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Charles River

ic 9.2/10 Overall Rating 90% Positive
ic 65 Orders Completed
Wilmington, Massachusetts, US

About Charles River

Founded: 1947 Type: Public Company Size: 5001-10,000 employees

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly... Show more »

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

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Certifications & Qualifications

AAALAC BSL-1 BSL-2 GCP GLP

Our Services (209)


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Cell and Tissue Culture

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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16S rRNA Sequencing

Price on request

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and... Show more »

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and can provide the appropriate cell storage services, all under Good Manufacturing Practice (GMP) guidelines. Our capabilities include purity, sterility, identity, genetic stability testing and an array of other characterization assays from our expansive testing portfolio. Our experienced technical staff can customize a project to create and characterize master cell banks, working cell banks, research cell banks, end-of-production cells and cells at the limit of in vitro cell age, according to client specifications.

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Purity Assay Copy Number GMP Mycoplasma Detection Sterility Microbial Contamination Cell Line Identification STR analysis DNA fingerprinting Barcode analysis Restriction Endonuclease Analysis bacteriophage testing viability testing RNA sequencing DNA sequencing retention of recombinant construct retention of selectable markers Genetic Stability 165 rDNA Sequencing Virology Contamination Adventitious Agent testing Show 21 more tags Show less

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Whole Genome Sequencing

Price on request

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and... Show more »

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and can provide the appropriate cell storage services, all under Good Manufacturing Practice (GMP) guidelines. Our capabilities include purity, sterility, identity, genetic stability testing and an array of other characterization assays from our expansive testing portfolio. Our experienced technical staff can customize a project to create and characterize master cell banks, working cell banks, research cell banks, end-of-production cells and cells at the limit of in vitro cell age, according to client specifications.

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Purity Assay Copy Number GMP Mycoplasma Detection Sterility Microbial Contamination Cell Line Identification STR analysis DNA fingerprinting Barcode analysis Restriction Endonuclease Analysis bacteriophage testing viability testing RNA sequencing DNA sequencing retention of recombinant construct retention of selectable markers Genetic Stability 165 rDNA Sequencing Virology Contamination Adventitious Agent testing Show 21 more tags Show less

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Plasmid DNA Preparation

Price on request

Charles River can detect and quantify minute amounts of residual host cell DNA by using three highly sensitive, validated methods. These methods encompass the entire range of residual DNA from nonspecific detection of total DNA to highly specific detection of single target sequences.

Charles River can detect and quantify minute amounts of residual host cell DNA by using three highly sensitive, validated methods. These methods encompass the entire range of residual DNA from nonspecific detection of total DNA to highly specific detection of single target sequences.

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GMP Hybridization Assay Threshold Assay qPCR Assay

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Parkinsons Disease Animal Models

Price on request

Charles River offers a comprehensive and more readily translatable modeling platform of chemically and biologically induced and genetic models to study mechanism of action and efficacy of novel PD therapies. The portfolio of animal models of Parkinson’s disease includes established chemically induced models (6-OHDA and MPTP) and... Show more »

Charles River offers a comprehensive and more readily translatable modeling platform of chemically and biologically induced and genetic models to study mechanism of action and efficacy of novel PD therapies. The portfolio of animal models of Parkinson’s disease includes established chemically induced models (6-OHDA and MPTP) and genetic models (alpha-synuclein).
Please find the following resource. Discovery:Neuroscience

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AAV-A53T Mice Parkinson's disease (PD) MPTP-induced Parkinson's disease model PD 6-OHDA AAV-A53T Mice unilateral 6-OHDA lesion MPTP Lesion model Show 8 more tags Show less

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Carcinogenicity/Tumorigenicity Testing

Price on request

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Carcinogenesis Animal Models

Price on request

Charles River offers the transgenic rasH2 mouse model as an alternative to the full 2-year carcinogenicity study design and has commenced more than 60 studies in this model since 2013. Please find the following resources. Safety: Carcinogenicity and... Show more »

Charles River offers the transgenic rasH2 mouse model as an alternative to the full 2-year carcinogenicity study design and has commenced more than 60 studies in this model since 2013. Please find the following resources. Safety: Carcinogenicity and Safety:Transgenic Carcinogenicity

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SNP Genotyping Data Analysis

Single nucelotide polymorphism genotyping data analysis
Price on request

RMS: Genetic Services

Charles River offers an array of off-the-shelf and custom-designed SNP panels designed to do everything from detecting a genetic contamination to fine-mapping a transgene insertion point.

RMS: Genetic Services

Charles River offers an array of off-the-shelf and custom-designed SNP panels designed to do everything from detecting a genetic contamination to fine-mapping a transgene insertion point.

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SNP Genotyping

Single Nucleotide Polymorphism Genotyping
Price on request

RMS: Genetic Services

Charles River offers an array of off-the-shelf and custom-designed SNP panels designed to do everything from detecting a genetic contamination to fine-mapping a transgene insertion point.

RMS: Genetic Services

Charles River offers an array of off-the-shelf and custom-designed SNP panels designed to do everything from detecting a genetic contamination to fine-mapping a transgene insertion point.

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Zygosity Testing

Price on request

It’s often difficult to discriminate between homozygous and hemizygous transgenic animals using traditional PCR, but the distinction between these zygositities is critical to transgenic breeding strategies, as well as to planning study cohorts. Charles River provides a definitive report on an animal’s zygosity quickly and... Show more »

It’s often difficult to discriminate between homozygous and hemizygous transgenic animals using traditional PCR, but the distinction between these zygositities is critical to transgenic breeding strategies, as well as to planning study cohorts. Charles River provides a definitive report on an animal’s zygosity quickly and accurately using our high-throughput, state-of-the-art qPCR technology.

RMS: Genetic Services

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Genotyping by PCR

Price on request

Fast, accurate genotyping conducted on a routine basis can help keep colony sizes manageable, select animals for study cohorts and set aside animals for future breeding. Our high-throughput, multi-platform genotyping laboratory delivers results in as little as 24 hours from sample receipt, facilitating more efficient colony... Show more »

Fast, accurate genotyping conducted on a routine basis can help keep colony sizes manageable, select animals for study cohorts and set aside animals for future breeding. Our high-throughput, multi-platform genotyping laboratory delivers results in as little as 24 hours from sample receipt, facilitating more efficient colony management.

RMS: Genetic Services

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Rodent Breeding

Price on request

Charles River provides off-site space for holding, breeding, and developing genetically engineered mouse and rat colonies. All colonies are assigned a dedicated project manager and clients are granted access to Charles River’s innovative Internet Colony Management (ICM™) system. Whether you want to simply maintain a line, produce... Show more »

Charles River provides off-site space for holding, breeding, and developing genetically engineered mouse and rat colonies. All colonies are assigned a dedicated project manager and clients are granted access to Charles River’s innovative Internet Colony Management (ICM™) system. Whether you want to simply maintain a line, produce regular animal shipments for your studies, or backcross your strain to a different genetic background, each breeding colony is scalable to your specific research needs.

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In vivo Drug Efficacy Testing

Price on request

In vivo pharmacology is the study of the biological effects of a drug in a complex living organism and is used to observe the complex physiological effects of a drug. Charles River offers early research and proof-of-principle pharmacology studies in relevant animal models of human diseases to assist your efficacy evaluations. Our... Show more »

In vivo pharmacology is the study of the biological effects of a drug in a complex living organism and is used to observe the complex physiological effects of a drug. Charles River offers early research and proof-of-principle pharmacology studies in relevant animal models of human diseases to assist your efficacy evaluations. Our scientific team has extensive experience helping clients with the selection of appropriate models and assays, as well as collaborating to design new models to meet the specific needs of a particular compound or discovery program. Capabilities include: Animal models of invection, Cardiovascular/Metabolic Disease pharmacology models, Inflammation and autoimmune disease models, musculoskeletal disease pharmacology models, neuroscience pharmacology models, ocular disease pharmacology models, oncology pharmacology models, rare disease pharmacology models, respiratory disease pharmacology models

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Oncology Animal Models

Price on request

Charles River’s experience with oncology drug discovery spans all phases, from target identification to IND studies. Utilizing the most effective combination of tools available to identify promising compounds, we work with our partners to design studies by selecting from amongst a broad range of well-characterized xenograft,... Show more »

Charles River’s experience with oncology drug discovery spans all phases, from target identification to IND studies. Utilizing the most effective combination of tools available to identify promising compounds, we work with our partners to design studies by selecting from amongst a broad range of well-characterized xenograft, patient-derived xenograft (PDX), and syngeneic tumor models. Combining those models with appropriate biomarkers, including flow cytometry and imaging, allows our partners to choose the most appropriate study design and screening method to identify promising compounds and optimize lead candidates. Please find the following resource. Discovery: Oncology

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PDX Patient-derived xenograft cell-line derived xenograft CDX human tumor xenograft

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In vivo Pharmacology Studies

Price on request

In vivo pharmacology is the study of the biological effects of a drug in a complex living organism and is used to observe the complex physiological effects of a drug. Charles River offers early research and proof-of-principle pharmacology studies in relevant animal models of human diseases to assist your efficacy evaluations. Our... Show more »

In vivo pharmacology is the study of the biological effects of a drug in a complex living organism and is used to observe the complex physiological effects of a drug. Charles River offers early research and proof-of-principle pharmacology studies in relevant animal models of human diseases to assist your efficacy evaluations. Our scientific team has extensive experience helping clients with the selection of appropriate models and assays, as well as collaborating to design new models to meet the specific needs of a particular compound or discovery program. Capabilities include: Animal models of invection, Cardiovascular/Metabolic Disease pharmacology models, Inflammation and autoimmune disease models, musculoskeletal disease pharmacology models, neuroscience pharmacology models, ocular disease pharmacology models, oncology pharmacology models, rare disease pharmacology models, respiratory disease pharmacology models

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Flow Cytometry

Price on request

Flow cytometry is a method that is easily added to in vitro and in vivo studies to comprehensively profile changes in immune cell populations in response to therapeutics. With a streamlined process for tissue dissociation, cell isolation, staining and acquisition, hundreds of systemic and tumor-infiltrating immune cells can be... Show more »

Flow cytometry is a method that is easily added to in vitro and in vivo studies to comprehensively profile changes in immune cell populations in response to therapeutics. With a streamlined process for tissue dissociation, cell isolation, staining and acquisition, hundreds of systemic and tumor-infiltrating immune cells can be processed per day to give clients the benefit of reviewing data and making decisions about compounds and studies in near-real time.

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immunology Oncology immuno-oncology syngeneic mouse models multiplex flow cytometry

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

With decades of experience running in vitro ADME assays and analyzing the data, we can offer those same in vitro assays and bioanalyses more efficiently to generate ADME data earlier in the drug discovery process. This high-speed process optimization and reproducibility can generate quality ADME data for every compound in your... Show more »

With decades of experience running in vitro ADME assays and analyzing the data, we can offer those same in vitro assays and bioanalyses more efficiently to generate ADME data earlier in the drug discovery process. This high-speed process optimization and reproducibility can generate quality ADME data for every compound in your chemical library. Please find the following resource. Discovery: Safety Assessment Services and Facilities

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LC-MS/MS In vivo assays in vitro assays DMPK ADME

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Animal Models and Studies

Price on request

Preconditioning services can help alleviate the space, time, and labor costs involved with refining a model to meet your unique research requirements. Whether you are looking for animals fed a special diet, altered through surgery, or reared to a certain age, Charles River has the state-of-the-art animal facilities, professional... Show more »

Preconditioning services can help alleviate the space, time, and labor costs involved with refining a model to meet your unique research requirements. Whether you are looking for animals fed a special diet, altered through surgery, or reared to a certain age, Charles River has the state-of-the-art animal facilities, professional animal care, and robust model selection to deliver study-ready animals right to your door. Please find the following resources. RMS:Surgical Services and RMS:Labstamp animal identification

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In vitro Immunotoxicity Testing

Price on request
Request a quote for more information about this service.
Mouse Rat Rodents Toxicology

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Biochemical Compound Screening

Price on request

The Charles River assay development and screening department offers a unique combination of target class and cell biology expertise together with state-of-the-art instrumentation to provide services tailored to your requirements.

We provide a collaborative environment and work closely with our teams in medicinal chemistry,... Show more »

The Charles River assay development and screening department offers a unique combination of target class and cell biology expertise together with state-of-the-art instrumentation to provide services tailored to your requirements.

We provide a collaborative environment and work closely with our teams in medicinal chemistry, ADME, structural biology and fragment-based drug discovery to deliver within challenging timelines.

Charles River has a range of orthogonal approaches that can deliver high-quality, validated hit compounds for your drug discovery project. These approaches can be applied in parallel or individually, depending on the nature of the project and the resources available. Our highly experienced teams regularly evaluate early-stage programs and will advise you concerning the best strategy for successful progression to hit-to-lead studies.

Hit Identification Approaches
High-throughput screening
Fragment screening
Virtual screening
Medicinal chemistry knowledge-based design

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Biology Drug Discovery

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Biomarker Analysis

Price on request

The identification and use of predictive biomarker assays has become an integral part of the drug discovery and development process. Charles River’s capabilities span the identification and validation of biomarkers and the development of quantitative assays in primary cells and disease tissue, pharmacodynamic and disease models,... Show more »

The identification and use of predictive biomarker assays has become an integral part of the drug discovery and development process. Charles River’s capabilities span the identification and validation of biomarkers and the development of quantitative assays in primary cells and disease tissue, pharmacodynamic and disease models, and as efficacy and translational medicine markers in the clinic. Please find the following resource. Safety: Biomarker Assay

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HPLC ELISA Enzyme immunoassay (EIA) Biomarkers Biomarker Identification Biomarker Assay Development predictive biomarkers Meso Scale Discovery (MSD®) Luminex® Show 9 more tags Show less

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Immunobiology Services

Price on request

We understand and have validated models for every cell in the immune system, and those cells which interact with it. This level of expertise is what enables our dedicated analytical and cell biology teams to run assays using primary cells that closely mimic human biology and are suitable for immunology drug screening... Show more »

We understand and have validated models for every cell in the immune system, and those cells which interact with it. This level of expertise is what enables our dedicated analytical and cell biology teams to run assays using primary cells that closely mimic human biology and are suitable for immunology drug screening programs.
Please find the following resources. Discovery:• Infectious Disease Drug Discovery: Pharmacology Models and In Vitro Capabilities, Discovery:Osteoarthritis Rat Model, Discovery:• Predictive Immunotoxicology Services, Discovery:• Pharmacodynamic Efficacy Biomarker Services, Discovery:Respiratory Disease Pharmacology Models, Discovery:Immunology Pharmacology Portfolio, Discovery:•End-to-end Capabilities to Assess Neuroinflammation, Discovery:Cell-based Assays for the Tumor Microenvironment, and Discovery:•End-to-end capabilities for Infectious Disease

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immunology

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In vivo Toxicity Testing

Price on request
Request a quote for more information about this service.

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Alzheimer's Disease Animal Models

Price on request

At Charles River, our scientists can guide you in the selection of the appropriate assay or disease model for every stage of the drug discovery process. Our extensive portfolio supports novel study designs and offers end-to-end validated in vitro services and in vivo models of pharmacology and toxicology. Our novel imaging... Show more »

At Charles River, our scientists can guide you in the selection of the appropriate assay or disease model for every stage of the drug discovery process. Our extensive portfolio supports novel study designs and offers end-to-end validated in vitro services and in vivo models of pharmacology and toxicology. Our novel imaging modalities, behavioral tests and biomarker endpoint assays enable you to make effective decisions to help identify new therapies for Alzheimer’s disease.
Alzheimer’s disease models available for studies include the transgenic CVN and Tg2576 mouse models, which display pathologies associated with Alzheimer’s disease. Aged rodents and scopolamine-induced amnesia models are also available. Established and novel AD models are validated using cognitive testing, MRI and nuclear imaging, measurement of the levels of soluble and insoluble beta amyloid, immunohistochemical measurements and relevant biomarkers. Our services provide an extensive platform for pharmaceutical research and development.
Please find the following resource. Discovery:Neuroscience

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Rodents aged rats aged mice aged rat aged mouse CNS/Neurology Alzheimers Disease cognitive decline Show 8 more tags Show less

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Biology

Price on request

The Charles River Ion Channel Portfolio is the most comprehensive library of ion channel-expressing cell lines for research, drug discovery and preclinical development. Cell lines are validated for structure, function and pharmacology, and performance is characterized on conventional manual patch clamp or on one or more automated... Show more »

The Charles River Ion Channel Portfolio is the most comprehensive library of ion channel-expressing cell lines for research, drug discovery and preclinical development. Cell lines are validated for structure, function and pharmacology, and performance is characterized on conventional manual patch clamp or on one or more automated electrophysiology platforms.   In addition to stable cell lines, we also offer EZCells,  which are single use, division arrested or transient transfected cells ideal for rapid, cost-effective screening and profiling.  We offer detailed methodology and consultation to support and expedite assay set up.   Charles River scientists have pioneered ion channel research for nearly 20 years, creating more than 120 functionally validated assays and cell lines. This industry-leading expertise, combined with our wide array of technologies for screening, profiling and mechanism of action (MOA) studies, makes us unmatched in our ability to support our partners’ quests for the discovery of novel ion channel therapeutics. Please find the following resources. Discovery: Ion Channel Portfolio

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Cell Lines CHO HEK293

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CNS/Neurology Animal Models

Price on request

Please find the following resource. Discovery: Neuroscience

Please find the following resource. Discovery: Neuroscience

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Cell-Based Compound Screening

Price on request

Charles River in vitro assay development services offers bespoke in vitro assay testing from target discovery through expression to provide insights that improve translation in vivo and ultimately the clinic. With over 100 validated in vitro human primary cell-based assays and access to patient-derived cell lines and gene editing... Show more »

Charles River in vitro assay development services offers bespoke in vitro assay testing from target discovery through expression to provide insights that improve translation in vivo and ultimately the clinic. With over 100 validated in vitro human primary cell-based assays and access to patient-derived cell lines and gene editing tools we have proven efficacy testing in oncology, neurology, immunology and rare diseases. Capabilities include human and rodent primary cell-based assays; oncology, immuno-oncology and immunology assays; antiviral and antimicrobial testing; rare disease assays, neuroscience assays, ion channel screening, mechanism of action studies, genome engineering techniques including RNAi and CRISPR.

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Hit Identification Approaches Fragment screening in vitro studies human primary cell based assay in vitro assay Biology Drug Discovery Show 7 more tags Show less

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Drug Discovery & Development

Price on request
Request a quote for more information about this service.
ELISA Potency Assay GMP N-terminal Sequencing Amino Acid Analysis Glycosylation Biosimilarity analysis Mass Spectrometry Biophysical Characterization liposomal product characterization glycan charaterization IBD hERG Action Potential Duration Assay Bioanalytical Assay Development and Optimization Biopharmaceutical Characterization Computational Drug Discovery Drug Absorption studies Drug Mechanisms of Action Studies Drug Targt Identification hERG Channel Inhibition Assay Hit Identification Lead Identification and Validation Inflammation and Immunology Pharmacology models Ion Channel Screening Cardiac Safety Assessment Dermatitis Scleroderma Psoriasis DTH Immune function RA Rheumatoid Arthritis SLE nephritis Anutoimmune uveitis Show 36 more tags Show less

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Imaging & Spectroscopy

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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analytical chemistry Circular Dichroism Fluorescence Fourier Transform Infrared Spectroscopy (FTIR) Spectroscopy Nuclear Magnetic Resonance MRS Magnetic Resonance Spectroscopy UV/VIS Absorbance UV-VIS Spectroscopy NMR Spectroscopy Show 11 more tags Show less

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Mycoplasma Testing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Drug Product Release

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PCR Spiroplasma Spiroplasma Detection Mycoplama detection Mycoplasma Testing spiroplasma testing QF-PCR Show 7 more tags Show less

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Veterinary Laboratory Services

Price on request
Request a quote for more information about this service.

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Assay Development

Price on request

Charles River scientists have more than 20 years of experience in the design and performance of viral and transmissible spongiform encephalopathy (TSE) clearance studies. With laboratories in Europe and the US, we have the technical and regulatory expertise to ensure studies comply with the relevant guidelines in a client’s target... Show more »

Charles River scientists have more than 20 years of experience in the design and performance of viral and transmissible spongiform encephalopathy (TSE) clearance studies. With laboratories in Europe and the US, we have the technical and regulatory expertise to ensure studies comply with the relevant guidelines in a client’s target market (e.g., EU, US, Japan, and WHO, including ICH Q5A). Intelligent, tailored study designs and robust, timely reporting create successful, cost-effective programs that meet the unique needs of each biopharmaceutical product. We have worked with a range of products, including monoclonal antibodies (mAbs), recombinant proteins, transgenic products, tissue- and blood-derived products, vaccines and medical devices. In addition, our team offers virus cleaning validation.

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assay development assay method development Assay Method validation Assay Method feasibility

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Cell-Based Assays

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Cell-based assays Cell-Based Screening Methods Custom Cell-Based Assay Development Specialized Cell-Based Assays

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Cell Line Authentication

Price on request

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and... Show more »

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and can provide the appropriate cell storage services, all under Good Manufacturing Practice (GMP) guidelines. Our capabilities include purity, sterility, identity, genetic stability testing and an array of other characterization assays from our expansive testing portfolio. Our experienced technical staff can customize a project to create and characterize master cell banks, working cell banks, research cell banks, end-of-production cells and cells at the limit of in vitro cell age, according to client specifications.

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Purity Assay Copy Number GMP Mycoplasma Detection Sterility Microbial Contamination Cell Line Identification STR analysis DNA fingerprinting Barcode analysis Restriction Endonuclease Analysis bacteriophage testing viability testing RNA sequencing DNA sequencing retention of recombinant construct retention of selectable markers virology Genetic Stability 165 rDNA Sequencing Virology Contamination Adventitious Agent testing Show 22 more tags Show less

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Cells and Tissues

Price on request
Request a quote for more information about this service.

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GEM Colony Care

Genetically Engineered Mouse Colony Care
Price on request

Charles River provides off-site space for holding, breeding, and developing genetically engineered mouse and rat colonies. All colonies are assigned a dedicated project manager and clients are granted access to Charles River’s innovative Internet Colony Management (ICM™) system. Whether you want to simply maintain a line, produce... Show more »

Charles River provides off-site space for holding, breeding, and developing genetically engineered mouse and rat colonies. All colonies are assigned a dedicated project manager and clients are granted access to Charles River’s innovative Internet Colony Management (ICM™) system. Whether you want to simply maintain a line, produce regular animal shipments for your studies, or backcross your strain to a different genetic background, each breeding colony is scalable to your specific research needs. Our Isolator-based animal quarantine facilities allow for the direct acceptance of animals from any institution worldwide, regardless of their known or unknown health status. This flexibility provides options to screen animals that would otherwise not be allowed into many animal facilities and speed up the process of acquiring valuable research animals. At the completion of the quarantine period, animals that are proven negative of excluded agents are allowed directly into most barrier facilities without the need to rederive. Charles River works with global customers on unique transgenic models to deliver study-ready cohorts to meet research needs. Our dedicated project management team, scientists, and animal care staff are always available to offer guidance, develop work plans, and help overcome any challenges. Through partnerships with genomics industry leaders, our combined expertise provides an optimum environment for generating, characterizing, preserving, and distributing your transgenic lines.

Charles River provides a wide range of genetically engineered models and services. Please see the following resources. GEMS:rederivation services , GEMS:Rapid Quarantine , GEMS:Line rescue services , GEMS:Transgenic models creation through colony expansion , GEMS:Model Creation , GEMS:Transgenic Model and Service

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Chemical Synthesis

Price on request

Charles River can assist in all aspects of drug discovery chemistry, including medicinal and synthetic chemistry, route development and optimization, purification and scale-up activities. Our scientists bring a wealth of experience from their prior roles in leading pharmaceutical and biotechnology companies. Consequently, they are... Show more »

Charles River can assist in all aspects of drug discovery chemistry, including medicinal and synthetic chemistry, route development and optimization, purification and scale-up activities. Our scientists bring a wealth of experience from their prior roles in leading pharmaceutical and biotechnology companies. Consequently, they are well-equipped to address the challenges of drug discovery projects and deliver high-quality outcomes to our clients. There is extensive knowledge in the eld of respiratory drug discovery, both oral and inhaled. The teams have a superb track record of delivering successful candidate drugs, and a detailed understanding of the design of inhaled compounds. We combine the latest synthetic chemistry methodologies and technologies with innovative synthetic route designs to ensure high productivity and maximum efficiency. We also utilize CADD with a history of success in computational screening.

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gram milligram

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Engineering and Fabrication

Price on request
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Histology and Pathology Services

Price on request

Charles River employs the largest assembly of pathologists in the contract research industry, offering multidisciplinary expertise for all types of drugs, biologics, chemicals, and devices and performing a wide array of routine and specialized pathology services either in support of in vivo studies performed at our sites or as a... Show more »

Charles River employs the largest assembly of pathologists in the contract research industry, offering multidisciplinary expertise for all types of drugs, biologics, chemicals, and devices and performing a wide array of routine and specialized pathology services either in support of in vivo studies performed at our sites or as a standalone service. Please find the following resource. Safety:Pathology Services

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Pathology services pathology laboratory pathology lab pathology associates

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ICP-MS

Inductively Coupled Plasma Mass Spectrometry
Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please see the following resources Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Drug Product Release

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ICP ICP-MS Elemental Impurities Inductively coupled plasma mass spectrometry

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Immunohistochemistry (IHC)

Price on request
  • Safety assessments for approximately 70 humanized, chimeric or murine monoclonal antibodies annually
  • Protocol development for over 80 different antibodies in a variety of species
  • Experience with unconjugated antibodies, antibodies conjugated to a variety of substances and Fab fragments
  • Techniques to reduce or eliminate... Show more »
  • Safety assessments for approximately 70 humanized, chimeric or murine monoclonal antibodies annually
  • Protocol development for over 80 different antibodies in a variety of species
  • Experience with unconjugated antibodies, antibodies conjugated to a variety of substances and Fab fragments
  • Techniques to reduce or eliminate the binding of secondary reagents to endogenous immunoglobulin, even when the tissue is of the same species as the immunoglobulin
  • Reproducibility of immunohistochemical techniques in conjunction with morphometric and stereological analyses
  • QIHC-certified staff using state-of-the-art automated staining instruments
  • Double IHC staining
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In vitro ADME/DMPK Studies

Price on request

Charles River helps clients identify the metabolic pathways, potential interactions and routes of elimination of their compound at an early stage. We can characterize your drug candidate's ADME properties through in vitro and in vivo studies providing expert study design and data interpretation. Please find the following resource.... Show more »

Charles River helps clients identify the metabolic pathways, potential interactions and routes of elimination of their compound at an early stage. We can characterize your drug candidate's ADME properties through in vitro and in vivo studies providing expert study design and data interpretation. Please find the following resource. Safety:Drug Metabolism

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In vitro Toxicity Testing

Price on request

Charles River has been leading the way in the development, validation, and acceptance of various animal-free models through rapid, reproducible, and reliable in vitro toxicology assays to examine the toxic properties of compounds of interest. Please find the following resource. Safety: Advanced in vitro Models

Charles River has been leading the way in the development, validation, and acceptance of various animal-free models through rapid, reproducible, and reliable in vitro toxicology assays to examine the toxic properties of compounds of interest. Please find the following resource. Safety: Advanced in vitro Models

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Cytotoxicity drug-drug interactions MiST hERG Cyp p450 in vitro studies metabolic toxicokinetic cell proliferation enzyme protein binding drug transporters reactive drug motabolites in vitro testing metabolism cytochrome caco-2 cells mic Show 19 more tags Show less

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In vivo PK/PD Studies

Price on request
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Process Consulting

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Project Management

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Toxicology

Price on request

Charles River designs and performs in vitro and in vivo safety programs to best characterize potential human drug toxicity and move your product from discovery to market in a rapid and efficient manner. Please find the following resource. Safety:Toxicology Services

Charles River designs and performs in vitro and in vivo safety programs to best characterize potential human drug toxicity and move your product from discovery to market in a rapid and efficient manner. Please find the following resource. Safety:Toxicology Services

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Tox preclinical toxicology studies Toxicology studies Toxicology testing toxicity testing Non-GLP Acute Toxicology Toxicology Toxicology Services Show 8 more tags Show less

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Cell Line Generation

Price on request

Charles River has extensive experience in generating stable cell lines for high-throughput screening and compound profiling. We offer a customized service, starting with stable expression of single proteins through to stable co-expression of multiple protein subunits.    You can also access a range of validated assays, in addition... Show more »

Charles River has extensive experience in generating stable cell lines for high-throughput screening and compound profiling. We offer a customized service, starting with stable expression of single proteins through to stable co-expression of multiple protein subunits.    You can also access a range of validated assays, in addition to our assay development and validation service, with expression profile selected to suit specific assay formats.

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High Throughput Screening Cell Lines In vitro biology Maxcyte GPCR cell lines compound profiling drug discovery Show 7 more tags Show less

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Protein Services

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Immunoassays Potency Assay western blot HPLC-SEC SDS-PAGE GMP N-terminal Sequencing DLS (Dynamic Light Scattering) Amino Acid Analysis Circular Dichroism IEF Osmolarity Residuals Biosimilarity analysis protein quantification Analytical Ultracentrifugation Peptide mapping Amino acid sequencing Spectrophotometric assays Biophysical Characterization product-related impurities intact molecular weight disulfide bridge mapping differential scanning calorimetry capillary zone electrophoresis intrinsic tryptophan fluorescence extrinsic fluorescence Surface plasmon resonance (SPR) Fourier Transform Infrared Spectroscopy (FTIR) Protein Characterization Protein Services Biocore Protein Biophysical Characterization Protein Structure Determination Show 34 more tags Show less

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qPCR

Quantitative PCR
Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources Biologics: Drug Product Release and Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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PCR qPCR qPCR Assay Quantitative Polymerase Chain Reaction Polymerase chain reaction

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RNA Sequencing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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RNA sequencing DNA sequencing Sanger Sequencing

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Sanger Sequencing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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RNA sequencing DNA sequencing Sanger Sequencing

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Surface Plasmon Resonance (SPR)

Price on request

Surface Plasmon Resonance

  • Biacore 4000 for high-throughput hit identification
  • Biacore T200 with added sensitivity for kinetic profiling, mechanistic analysis and backup screening

Please find the following resource [Biologics: Comprehensive Services for Biologics Developers and... Show more »

Surface Plasmon Resonance

  • Biacore 4000 for high-throughput hit identification
  • Biacore T200 with added sensitivity for kinetic profiling, mechanistic analysis and backup screening

Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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Biacore T-200 Biacore 4000 Surface plasmon resonance (SPR) SPR potency Biacore Biacore Show 7 more tags Show less

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Hydrolyzed Amino Acid Analysis

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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Amino Acid Analysis Extinction Coefficient analytical testing AAA hydrolyzed Amino Acid Analysis Protein Chemistry extinction coefficient determination Show 7 more tags Show less

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HPLC

High Performance Liquid Chromatography
Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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HPLC UPLC GMP GC Liquid Chromatography Chromatography LC Analytical High Performance Liquid Chromatography Show 9 more tags Show less

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Synthetic Chemistry

Price on request

High-quality synthetic chemistry creating novel compounds to progress your drug discovery programs. Capabilites include: Multi-stage syntheses (>10 steps) of milligram quantities (larger amounts can be prepared by our scale-up team); Validation of synthetic routes to previously unknown scaffolds; Parallel chemistry including the... Show more »

High-quality synthetic chemistry creating novel compounds to progress your drug discovery programs. Capabilites include: Multi-stage syntheses (>10 steps) of milligram quantities (larger amounts can be prepared by our scale-up team); Validation of synthetic routes to previously unknown scaffolds; Parallel chemistry including the synthesis of small arrays; Chiral synthesis and resolution; Flow chemistry; Automated mass-directed purification; Analytical and semi-prep supercritical fluid chromatography

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LC-MS

Liquid Chromatography-Coupled Mass Spectrometry
Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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Mass Spec LC-MS Mass Spectrometry Liquid Chromatography

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DNA Sequencing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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RNA sequencing DNA sequencing Sanger Sequencing

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Mass Spectrometry

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Mass Spec LC-MS/MS MALDI-TOF LC-MS ICP-MS Mass Spectrometry MS Show 7 more tags Show less

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Monoclonal Antibody (mAb) Production

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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Monoclonal Anbtibody (mAB) Production mAB Monoclonal antibodies Monoclonal antisera monoclonal antisera production

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Analytical Chemistry Services

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.Formulation development services range from preformulation investigations to analytical method development and validation. Charles River prepares formulations based on our extensive knowledge of vehicle suitability in animal models for most formulation types to support GLP preclinical studies. Please fine the following resource. Safety: Formulation Development/AnChem

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HPLC UPLC assay development Quality Control analytical chemistry GMP stability Method Development Method Validation QC testing formulation development Formulation assay validation Analytical Development Release Testing Preformulation concentration homogeneity bioavailability Show 19 more tags Show less

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Protein Production

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Cell Banking and Storage and Biologics: Cell Line Characterization

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Monoclonal Anbtibody (mAB) Production mAB Monoclonal antibodies Monoclonal antisera monoclonal antisera production

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ELISA

Enzyme-linked immunosorbent assay
Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource. Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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ELISA Enzyme-linked immunosorbent assay Residual Testing Impurities testing

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Chemistry and Materials

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Patch Clamp Recording

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Patient-Derived Xenograft (PDX)

Price on request

We currently have more than 400 fully characterized proprietary patient-derived xenografts in our portfolio, which represent all major histotypes and tumors, and provide extensive background and characterization. Our PDX Model portfolio includes:
Subcutaneous, orthotopic, and disseminated models of cancer, extensive molecular and... Show more »

We currently have more than 400 fully characterized proprietary patient-derived xenografts in our portfolio, which represent all major histotypes and tumors, and provide extensive background and characterization. Our PDX Model portfolio includes:
Subcutaneous, orthotopic, and disseminated models of cancer, extensive molecular and pharmacological characterization, and complete records on patients‘ pretreatment, integrated approach using the same PDX models and/or the corresponding cell line, 2D/3D screening assays and subsequent PDX in vivo efficacy studies, identification of biomarkers, which predicts tumor sensitivity of compounds and a PDX Model platform using humanized mice in standard or single mouse trial format (SMT).

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PDX drug discovery Oncology in vivo efficacy

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Animal Models of Disease

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Cell Lines

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers, Biologics: Cell Banking and Storage and Biologics: Cell Line Characterization

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Purity Assay Copy Number GMP Mycoplasma Detection Sterility Microbial Contamination Cell Line Identification STR analysis DNA fingerprinting Barcode analysis Restriction Endonuclease Analysis bacteriophage testing viability testing RNA sequencing DNA sequencing retention of recombinant construct retention of selectable markers Genetic Stability 165 rDNA Sequencing Virology Contamination Cell Line testing Adventitious Agent testing Show 22 more tags Show less

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Virology Testing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Drug Product Release

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retrovirus detection assays Virology testing In vitro adventitious virus testing adenovirus assay

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In vitro Disease Models

Price on request

Charles River in vitro assay development services offers bespoke in vitro assay testing from target discovery through expression to provide insights that improve translation in vivo and ultimately the clinic. With over 100 validated in vitro human primary cell-based assays and access to patient-derived cell lines and gene editing... Show more »

Charles River in vitro assay development services offers bespoke in vitro assay testing from target discovery through expression to provide insights that improve translation in vivo and ultimately the clinic. With over 100 validated in vitro human primary cell-based assays and access to patient-derived cell lines and gene editing tools we have proven efficacy testing in oncology, neurology, immunology and rare diseases. Capabilities include human and rodent primary cell-based assays; oncology, immuno-oncology and immunology assays; antiviral and antimicrobial testing; rare disease assays, neuroscience assays, ion channel screening, mechanism of action studies, genome engineering techniques including RNAi and CRISPR

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in vitro assays in vitro studies human primary cell based assays

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Pharmaceutical Formulation

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource. Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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Formulation drug development Preformulation Protein Formulation manufacturing services

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Energy Dispersive Spectroscopy

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Biomarkers

Price on request

Choosing the right translational biomarker is based on whether it is detectable, measurable and, in the end, able to be qualified or validated. Charles River advises on selecting the appropriate biomarker, analytical methodology and pull through from nonclinical to clinical use. Please see the following resource. [Safety:Biomarker... Show more »

Choosing the right translational biomarker is based on whether it is detectable, measurable and, in the end, able to be qualified or validated. Charles River advises on selecting the appropriate biomarker, analytical methodology and pull through from nonclinical to clinical use. Please see the following resource. Safety:Biomarker Assays

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Clinical Sample Analysis

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Compound Identification and Characterization

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Charles River has a full suite of capabilities to provide chemical purity (including chiral purity) and structural elucidation on compounds, impurities and degradants. We have access both internally and externally to state-of-the-art technologies, including high-field and solid-state NMR, high-resolution MS-MS and X-ray... Show more »

Charles River has a full suite of capabilities to provide chemical purity (including chiral purity) and structural elucidation on compounds, impurities and degradants. We have access both internally and externally to state-of-the-art technologies, including high-field and solid-state NMR, high-resolution MS-MS and X-ray diffraction.    If required, compounds can also be characterized by IR or Raman spectroscopy and their optical rotation/circular dichroism determined. Elemental analysis and small molecule crystallography are also available via third parties.  The reports produced by Charles River are suitable for inclusion in an IMPD (Investigational Medicinal Product Dossier).    In house:    - Two 400 MHz and two 300 MHz NMR instruments  - 14 mass spectrometers  - Agilent mass-directed autopurification system.

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NMR Raman Spectroscopy Infrared Spectroscopy

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Cognitive, Behavioral, and Psychiatric Animal Models

Price on request

Charles River offers several models of psychiatric disease including autism, schizophrenia, anxiety and depression. Charles River scientists recently characterized the BTBR T+tf/J model of autism using behavioral studies and noninvasive imaging to validate its utility for preclinical drug discovery of ASD therapies.... Show more »

Charles River offers several models of psychiatric disease including autism, schizophrenia, anxiety and depression. Charles River scientists recently characterized the BTBR T+tf/J model of autism using behavioral studies and noninvasive imaging to validate its utility for preclinical drug discovery of ASD therapies.
Additionally, our neuroscientists conduct contract studies in mice to assess the efficacy of novel anti-anxiety compounds, such as anxiolytics and selective serotonin reuptake inhibitors (SSRIs).
You can partner with our scientists to run your studies in well-characterized, disease-relevant models, using a comprehensive toolkit of imaging capabilities, behavioral assays and biomarkers including the forced swim test and touchscreen testing.
Charles River has validated a pencyclidine (PCP)-induced deficit model, which recapitulates several behavioral deficits, mimicking the symptoms of schizophrenia. This model displays both positive and negative symptoms, including cognitive deficits, and facilitates the development of drugs for either or both symptom categories.

Charles River offers mouse behavior analysis via touchscreen-based tests. The touchscreen tests possess several advantages over traditional methods of rodent cognitive assessment and are highly translational as they rely on the stimuli and actions similar to those used in human cognitive assessments. Due to their emphasis on sustained performance, touchscreen tests can be used in longitudinal pharmacological studies and this method can be easily combined with other behavioral or functional tests.

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Mouse Rat Psychiatry/Mental Health CNS/Neurology Neurodegenerative diseases

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Computational Drug Discovery

Price on request

Collaborating with Charles River‚Äôs Computer-Aided Drug Design (CADD) group puts leading informatics, virtual screening and molecular modeling expertise at your fingertips. Our highly experienced team works closely with our colleagues in medicinal chemistry, screening and structural biology to support projects and also plays a... Show more »

Collaborating with Charles River’s Computer-Aided Drug Design (CADD) group puts leading informatics, virtual screening and molecular modeling expertise at your fingertips. Our highly experienced team works closely with our colleagues in medicinal chemistry, screening and structural biology to support projects and also plays a leading role in the design of our fragment and SoftFocus® libraries. Our CADD capabilities are available as part of integrated hit identification, hit expansion, hit-to-lead and lead optimization programs or as a stand-alone offering. - Structure-based drug design - Ligand-based drug design - Virtual screening - Protein modeling - QSAR modeling - Screening library design and subset selection - Design of fragment and SoftFocus® libraries - HTS data triage - Chemo- and bio-informatics

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Pain/Neuropathy Animal Models

Price on request

Charles River conducts several hundred disease model studies on candidates targeting various types of pain including acute pain, inflammatory pain and neuropathic pain. We have developed a variety of clinically relevant pain models that have been validated using existing and novel methods to effectively test new therapeutic... Show more »

Charles River conducts several hundred disease model studies on candidates targeting various types of pain including acute pain, inflammatory pain and neuropathic pain. We have developed a variety of clinically relevant pain models that have been validated using existing and novel methods to effectively test new therapeutic candidates. Capabilites include: neuropathic pain model, chronic joint pain model, inflammatory pain model, spinal nerve ligation model, peripheral neuroinflammation model, nociceptive pain model.
Please find the following resource. Discovery:Neuroscience

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Spinal Nerve Ligation (SNL) Pain neuropathic pain chronic joint pain inflammatory pain peripheral neuroinflammation nociceptive pain Show 7 more tags Show less

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Xenograft Models

Price on request

Cell-line derived or patient-derived tumor xenografts are used to conduct in vivo efficacy evaluation of potential cancer therapies. Our broad range of well-characterized CDX and PDX tumor lines ensures a wide variety of testing alternatives for your molecule; complete profiling can be carried out in a variety of tumor types or in... Show more »

Cell-line derived or patient-derived tumor xenografts are used to conduct in vivo efficacy evaluation of potential cancer therapies. Our broad range of well-characterized CDX and PDX tumor lines ensures a wide variety of testing alternatives for your molecule; complete profiling can be carried out in a variety of tumor types or in combination with the desired clinical compound. Efficacy evaluation can be combined with: Hematology (CBC/Diff) analysis; Pharmacokinetic or bioavailability sampling and analysis; Histopathology or tissue sampling; Biomarker screening, sampling or evaluation

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PDX Patient-derived xenograft cell-line derived xenograft CDX human tumor xenograft

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Animal Microdialysis

Price on request

Microdialysis is a minimally-invasive sampling technique used to measure unbound analyte concentrations in extracellular fluid and tissues. At Charles River, we offer conventional microdialysis to measure small molecular weight analytes as well as push-pull microdialysis to measure larger molecules. Additionally, the proprietary... Show more »

Microdialysis is a minimally-invasive sampling technique used to measure unbound analyte concentrations in extracellular fluid and tissues. At Charles River, we offer conventional microdialysis to measure small molecular weight analytes as well as push-pull microdialysis to measure larger molecules. Additionally, the proprietary MetaQuant method is used to sample various tissues. We can customize assays by combining microdialysis with other methods such as behavior or EEG measurements.
Accuracy and sensitivity are critical parameters for bioanalysis and Charles River provides a wide range of bioanalytical services. A combination of expert scientists and state of the art equipment allows us to offer novel analytical techniques to analyze low concentrations of multiple neurotransmitters simultaneously in a single run.
Please find the following resource. Discovery:Translational tool for neuroscience

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CNS/Neurology Conventional Microdialysis push-pull microdialysis

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Drug Development Consulting

Price on request
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DART Studies

Developmental and Reproductive Toxicology Studies
Price on request

Developmental and reproductive toxicology (DART) services for the progression of pharmaceuticals and biopharmaceuticals include male and female fertility, developmental toxicity and pre/postnatal development (PPND) studies to assess the potential effects of a test article on the full spectrum of reproduction. Please find the... Show more »

Developmental and reproductive toxicology (DART) services for the progression of pharmaceuticals and biopharmaceuticals include male and female fertility, developmental toxicity and pre/postnatal development (PPND) studies to assess the potential effects of a test article on the full spectrum of reproduction. Please find the following resources. Safety: Reproductive Toxicology

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Rabbit Sheep Goat Mouse Pig Rat Cow Minipig Reproductive Toxicology developmental and reproductive toxicology developmental toxicology juvenile toxicology juvenile toxicity testing DART testing endocrine disruptor screening Show 15 more tags Show less

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Drug Mechanism of Action Studies

Mechanism of Action Studies
Price on request

Charles River uses its adenoviral technology to elucidate the mechanism of action of small molecules. By combining the compound of interest with knockdown or overexpression of candidate gene in the same phenotypic assay, we can start to elucidate the mechanism of action of the compound(s). In addition, we are able to access our... Show more »

Charles River uses its adenoviral technology to elucidate the mechanism of action of small molecules. By combining the compound of interest with knockdown or overexpression of candidate gene in the same phenotypic assay, we can start to elucidate the mechanism of action of the compound(s). In addition, we are able to access our other technologies to perform mode-of-action studies: - Use of our in-house chemogenomics database to predict candidate targets - Cross-screening of compounds of interest through panels of biochemical and cell-based assays linked by candidate pathways or candidate gene families - Biophysical assays to look for compound binding to candidate target proteins – SPR, size exclusion chromatography, X-ray crystallography

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Pharmacology & Toxicology

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PK/PD Data Analysis

Price on request

Charles River provides bioanalytical support for samples generated in toxicology studies, and the resultant test article/item concentration data can be interpreted by our pharmacokinetics staff utilizing industry-standard WinNonlin® software using noncompartmental and compartmental approaches. We offer this as an integrated... Show more »

Charles River provides bioanalytical support for samples generated in toxicology studies, and the resultant test article/item concentration data can be interpreted by our pharmacokinetics staff utilizing industry-standard WinNonlin® software using noncompartmental and compartmental approaches. We offer this as an integrated service, where all aspects of the study are managed within our laboratories, or as a stand-alone service, which enables analysis of concentration data generated elsewhere by the sponsor.
Toxicokinetic parameter estimation output includes a comprehensive interpretation of the data, as required. In addition, we can address preclinical-to-clinical considerations (e.g., allometric scaling) when planning first-in-human studies.

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WinNonlin®

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Electron Microscopy

Price on request

Charles River offers full-service GLP and non-GLP electron microscopy (EM) with both scanning and transmission capabilities in multiple locations. Our experienced staff is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample... Show more »

Charles River offers full-service GLP and non-GLP electron microscopy (EM) with both scanning and transmission capabilities in multiple locations. Our experienced staff is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample integrity.
In addition to our microscopy capabilities, we have extensive imaging laboratory services that can support your research and development efforts, including DXA, QCT, micro-CT and digital radiography.

Applications:

  • Ultrastructural pathology
  • Quantification of peroxisomes
  • Viral particle identification, characterization and tabulation
  • Cell culture contamination identification
  • Evaluation of tissue/medical device interface
  • Characterization of red blood cell morphology

Services:

  • Transmission electron microscopy (TEM)
  • Scanning electron microscopy (SEM)
  • Light microscopy
  • Dual-energy X-ray absorptiometry (DXA)
  • Quantitative computed tomography (QCT)
  • Micro-computed tomography (Micro-CT)
  • Digital radiography
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Electrophysiology

Price on request

Charles River offers a comprehensive portfolio of electrophysiology assays to monitor neuron-to-neuron communication and study the effects of physiological or pharmacological stimuli. Assays include single cell recordings, brain slice electrophysiology, and In vitro / ex vivo patch clamp studies to get a comprehensive... Show more »

Charles River offers a comprehensive portfolio of electrophysiology assays to monitor neuron-to-neuron communication and study the effects of physiological or pharmacological stimuli. Assays include single cell recordings, brain slice electrophysiology, and In vitro / ex vivo patch clamp studies to get a comprehensive understanding of the effect of a therapeutic on neuronal activity, synaptic changes and firing rates. The recordings are a valuable tool in the study of synaptic plasticity, which is thought to underlie learning, memory and some brain pathologies. Up- or down-regulation of synaptic transmission can shed light on cellular and network mechanisms of numerous CNS diseases, including Alzheimer's disease, autism and ataxia. Please find the following resource. Discovery:Neuroscience Translational Tool

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CNS/Neurology Neuroscience Synaptic firing electrical signals LTP brain slice ephys multi-electrode arrays Show 7 more tags Show less

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Bioanalytical Assays

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Protein Crystallization Screening and Optimization

Price on request

The structural biology team at Charles River carries out high-resolution structure determination by X-ray crystallography to support both stand-alone and integrated drug discovery projects. We have access to both in-house and synchrotron data collection facilities to provide fast turnaround and high-throughput structure... Show more »

The structural biology team at Charles River carries out high-resolution structure determination by X-ray crystallography to support both stand-alone and integrated drug discovery projects. We have access to both in-house and synchrotron data collection facilities to provide fast turnaround and high-throughput structure determination (including fragment screening campaigns). Integration of protein production, crystallization and structure solution allows for efficient streamlining of the structure determination process. The resulting structures, combined with the significant industrial design experience of our crystallographers and integrated with results from advanced biophysical assays, allow us to detail protein-ligand interactions at a structural, kinetic and thermodynamic level and provide insight to drug design projects. - Robotic nanoliter-scale screening and imaging - Screening with known ligands - Automated optimization of conditions for crystal growth - Co-crystallization or soaking of ligands

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X-ray crystallography

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Ligand Binding Assays

Price on request

Charles River scientists are global leaders in this rapidly growing and evolving field of ligand binding assays including peptides, monoclonal antibodies (mAb), multi-domain antibodies, antibody-drug conjugates (ADC), biosimilars, and traditional and next-generation oligonucleotides. Ligand binding assay bioanalysis is not an... Show more »

Charles River scientists are global leaders in this rapidly growing and evolving field of ligand binding assays including peptides, monoclonal antibodies (mAb), multi-domain antibodies, antibody-drug conjugates (ADC), biosimilars, and traditional and next-generation oligonucleotides. Ligand binding assay bioanalysis is not an independent discipline, our scientists work closely with our immunogenicity, pharmacokinetic and statistical specialists to deliver the pertinent solutions and interpretations applicable to your molecule and your study. Platforms: - Ligand binding assays (ELISA and MSD) - Automated ELISA systems - Ligand binding with LC-MS detection (Hybrid assays) - LC-MS/MS - Oligonucleotides - High-resolution mass spectrometry - Luminex technologies - Radioimmunoassay (RIA) - Enzyme immunoassay (EIA) - Fluorescence immunoassay (FIA) - Immunoradiometric assay (IRMA) - Dissociation-enhanced lanthanide fluorescence immunoassay (DELFIA) - Scintillation proximity assay (SPA)

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Immunoassays Radioimmunoassay (RIA) Mass Spectrometry Enzyme immunoassay (EIA) Fluorescence immunoassay (FIA) Immunoradiometric assay (IRMA) Dissociation-enhanced lanthanide fluorescence immunoassay (DELFIA) Scintillation proximity assay (SPA) ligand binding assays (ELISA and MSD) Ligan Binding with LC-MS Detection Luminex-AE Automated ELISA Show 12 more tags Show less

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Cancer Cell Line Panels

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Material Testing Services

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Quality Control analytical chemistry GMP QC testing Analytical Development Release Testing Show 6 more tags Show less

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Medicinal Chemistry

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Our medicinal chemistry team is world-class, with many of our scientists bringing a wealth of experience from previous employment in the pharmaceutical and biotechnology industries. With our exposure to a wide range of therapeutic areas and collaborative working styles, we are well equipped to drive your program forward. We have... Show more »

Our medicinal chemistry team is world-class, with many of our scientists bringing a wealth of experience from previous employment in the pharmaceutical and biotechnology industries. With our exposure to a wide range of therapeutic areas and collaborative working styles, we are well equipped to drive your program forward. We have an enviable record of delivering 64 preclinical candidates to our partners, and the strength and consistency of our innovation is exemplified by inventorship on more than 290 patent applications filed by clients.    We provide integrated drug discovery services spanning hit identification, hit-to-lead and lead optimization, all complemented by synthetic, process and scale-up chemistry, computer-aided drug design, structural biology, assay development and screening, and comprehensive ADME and PK profiling.    Key Skills and Experience  Delivery of high-quality preclinical candidates  Broad therapeutic disease area expertise (e.g., respiratory, CNS, oncology, inflammation)  Significant experience working across all druggable gene family target classes  Problem-solving expertise and creativity  Interpretation of biological data  Understanding of physicochemical properties  Application of compound quality metrics  Development of structure-activity relationships  Removal of unwanted off-target activities  Optimization of ADME, PK and PK/PD profiles  Ability to execute patenting strategies. Please find the following resource. Discovery:Medicinal Chemistry Handbook

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PK/PD PK ADME Drug Discovery

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hERG Channel Inhibition Assay

Price on request

In vitro hERG patch clamp assays have become standard components in cardiac safety evaluation during nonclinical drug development. Conventional manual patch clamp evaluation of hERG potency in the presence of 100% fetal bovine serum (FBS, dialyzed) evaluates the effect of drug-protein binding on hERG inhibition.

In vitro hERG patch clamp assays have become standard components in cardiac safety evaluation during nonclinical drug development. Conventional manual patch clamp evaluation of hERG potency in the presence of 100% fetal bovine serum (FBS, dialyzed) evaluates the effect of drug-protein binding on hERG inhibition.

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hERG hERG Channel Inhibition Assay Ion Channel Screening Cardiac Safety Assessment

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Transdermal/Transmucosal Drug Delivery Systems

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Microbial Identification and Strain Typing

Price on request

Axcess® System for Microbial Identification

The Axcess® system pairs the precision of the MALDI Biotyper instrument with the industry-leading Accugenix® proprietary microbial library through a secure online network. Based on MALDI-TOF mass spectrometry, the MALDI Biotyper is a paradigm shift which has become widely accepted... Show more »

Axcess® System for Microbial Identification

The Axcess® system pairs the precision of the MALDI Biotyper instrument with the industry-leading Accugenix® proprietary microbial library through a secure online network. Based on MALDI-TOF mass spectrometry, the MALDI Biotyper is a paradigm shift which has become widely accepted across industry segments as the next generation of microbial identification. While conventional identification methods are time-consuming and often require ancillary tests, the Axcess® system allows for nearly instantaneous identification of isolated colonies from a plate.

AccuBLAST®
Analysis & Interpretation of 16S Raw Data Sequence Files (*.ab1)

Exclusively designed for customers who have purchased the MicroSEQ® identification system, this service is provided for users who are not confident in the identifications made by the automated system. The AccuBLAST® service employs our own unrivaled sequence libraries and expert data analysis to generate meaningful reports, allowing us to deliver IDs more quickly and accurately.

AccuPRO-ID®
Proteotypic Identification of Bacteria and Yeast (MALDI-TOF Backed by 16S/ITS Sequencing)

AccuPRO-ID®, MALDI-TOF identification, is supported by AccuGENX-ID® rDNA sequencing. We have been offering this technology under cGMP for industrial applications since 2010, longer than any other contract laboratory in the industry. Our MALDI-TOF library is specific to industrial manufacturing environments; this maintains higher confidence in species-level identifications and yields accurate and effective ability to track and trend data that is pertinent to your environmental monitoring program.

AccuGENX-ID®
Genotypic Identification of Bacteria and Fungi (rDNA Sequencing)

The most accurate and reproducible method for identifying unknown microorganisms, AccuGENX-ID® utilizes comparative DNA sequencing of the 16S rRNA gene in bacteria and the ITS2 rRNA region in fungi through our BacSeq and FunITS identifications. This sequencing method is independent of the health or growth conditions of the isolate; samples can be viable or nonviable cultures, or simply genomic DNA from your microbe. For each sample submitted for identification, the resulting DNA sequence is compared against our validated libraries for bacteria and fungi. Our sequencing services are the most accurate method for identification of unknown microorganisms. This is important for contamination investigations.

AccuGENX-ST®
Sequence-Based Strain Typing - (M/SLST)

In production facilities, it is often necessary to determine the source of a contamination, the root cause, by
differentiating organisms to the subspecies (strain level). Strain typing allows you to ascertain how closely related an organism is to the same species observed in past events, or to verify if a certain production strain is the correct one. Our sequence-based strain typing method targets genes specific to the characterization of the species.

QC Custom Solutions

Identification and characterization, preservation and secure storage, and custom manufacturing in ready-to-use kit formats for your compendial testing.

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PCR MLST Multi-Locus Sequence Typing ITS2 rDNA sequencing MALDI-TOF Mass Spec SLST isolate storage isolate preservation Bacteria Yeast Fungi Yeast Bacteria Show 13 more tags Show less

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Transgenic Animal Model Development

Price on request

Charles River works with global customers on unique transgenic models to deliver study-ready cohorts to meet research needs. Our dedicated project management team, scientists, and animal care staff are always available to offer guidance, develop work plans, and help overcome any challenges. Through partnerships with genomics... Show more »

Charles River works with global customers on unique transgenic models to deliver study-ready cohorts to meet research needs. Our dedicated project management team, scientists, and animal care staff are always available to offer guidance, develop work plans, and help overcome any challenges. Through partnerships with genomics industry leaders, our combined expertise provides an optimum environment for generating, characterizing, preserving, and distributing your transgenic lines.

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Mouse Mice RNAi Knockin Mice Knockout Mice Model Creation Transgenic model creation genomics CRISPR/Cas9 genome editing microinjection services transgenes SNP modification ES Cell Injection CRISPR Injection plasmid BAC DNA ES Cell mutagenesis DNA Transgenesis Show 19 more tags Show less

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Transporter & Cell Uptake Assays

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Clinical Trials, Consulting, and Management

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Mouse Models

Price on request

With more than 20 breeding facilities around the world, Charles River is the leading global supplier of standard mouse models for biomedical research. Charles River stocks and strains are managed under the International Genetic Standardization (IGS) program, a unique program designed to manage the health and genetics of outbred... Show more »

With more than 20 breeding facilities around the world, Charles River is the leading global supplier of standard mouse models for biomedical research. Charles River stocks and strains are managed under the International Genetic Standardization (IGS) program, a unique program designed to manage the health and genetics of outbred and inbred strains on a global basis, ensuring that researchers worldwide have access to standardized models, regardless of the production location. Please find the following resource. RMS: Germ-Free Mice

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Mice inbred mice outbred mice hybrid mice germ-free mice immunodeficient mice nude mice SCID mice congenic mice Coisogenic mice oncology mice humanized mice microbiome mice Mouse Models Show 14 more tags Show less

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3D Cell Culture Models

Price on request

In conjunction with our drug sensitivity and molecular characterization data, our 3D assays, done by using our proprietary patient-derived xenograft (PDX) explants, enable you to evaluate the potency of your compound compared to standard-of-care drugs. This allows you to identify the most promising drug candidates, tumor... Show more »

In conjunction with our drug sensitivity and molecular characterization data, our 3D assays, done by using our proprietary patient-derived xenograft (PDX) explants, enable you to evaluate the potency of your compound compared to standard-of-care drugs. This allows you to identify the most promising drug candidates, tumor histotypes and molecular subtypes for further testing.

Data collected in these assays can then be used to select PDX models for subsequent in vivo efficacy tests. The data can also be used to run systematic two-drug combination therapy studies over a range of concentrations and to correlate the tumor response with molecular data (biomarker identification).

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PDX Patient-derived xenograft 3D Tissue Culture spheriod assays

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Hit to Lead and Lead Optimization

Price on request

Hit to lead: Charles River conducts hit-to-lead projects in an efficient cycle of rational design, synthesis and biological evaluation. Typically, multiple hit series are evaluated in parallel, with a view to establishing the scope for further optimization. One or two series are then selected for progression into lead optimization... Show more »

Hit to lead: Charles River conducts hit-to-lead projects in an efficient cycle of rational design, synthesis and biological evaluation. Typically, multiple hit series are evaluated in parallel, with a view to establishing the scope for further optimization. One or two series are then selected for progression into lead optimization studies.
Lead optimization projects: We are able to consistently deliver high-quality development candidates (over 75 since 2001) within industry standard timelines, including the data required to support progression into investigational new drug studies. A significant percentage of the 75+ candidates identified have progressed to clinical proof-of-concept, illustrating their high quality.

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Lead optimization Hit to lead

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Traumatic Brain Injury Animal Models

Price on request

Charles River conducts contract studies in established animal models of traumatic brain injury (TBI) to test the efficacy of novel therapeutics. We offer acute or long-term (chronic) histological, functional and behavioral follow-up along with detailed MRI/MRS imaging capabilities.

Charles River conducts contract studies in established animal models of traumatic brain injury (TBI) to test the efficacy of novel therapeutics. We offer acute or long-term (chronic) histological, functional and behavioral follow-up along with detailed MRI/MRS imaging capabilities.

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Rodents CNS/Neurology Spinal cord injury TBI Traumatic Brain injury

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Vaccine Production

Price on request

Charles River Laboratories can help expedite our clients’ vaccine development programs, from manufacturing for early-phase clinical trials through to lot release (potency assays) for commercial products. We have more than 20 years of experience manufacturing vaccines and viruses in cell culture, including dengue, influenza, and... Show more »

Charles River Laboratories can help expedite our clients’ vaccine development programs, from manufacturing for early-phase clinical trials through to lot release (potency assays) for commercial products. We have more than 20 years of experience manufacturing vaccines and viruses in cell culture, including dengue, influenza, and respiratory syncytial viruses.
Services:

  • cGMP virus and cell banking
  • Vaccine manufacturing via cell culture and SPF eggs
  • Vaccines for clinical trials (manufacturing scale – up to 7,500 vials per batch)
  • Pilot-scale virus manufacturing
  • Adaptation of production using animal component free reagents
  • Ability to work with clients to optimize processes and raise titers

Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers, Biologics: Cell Banking and Storage and Biologics: Cell Line Characterization

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GMP manufacturing Cell Banking Vaccine Production Virus Production

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Hybrid LBA/LC-MS Assays

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Ocular Toxicology

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Charles River performs safety and efficacy assessments for all ocular indications and tests for ocular effects of compounds administered by other routes. Ocular toxicity is characterized by one or more adverse changes that affect the structure or function of the eye following application of a substance, drug, or device. Please... Show more »

Charles River performs safety and efficacy assessments for all ocular indications and tests for ocular effects of compounds administered by other routes. Ocular toxicity is characterized by one or more adverse changes that affect the structure or function of the eye following application of a substance, drug, or device. Please find the following resource. Safety: Ocular Toxicology

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Rabbit Mouse Rat Minipig MPI Research Ocular Research Ocular Image Ocular Study Macular Degeneration AMD Diabetic Retinopathy glaucoma cytomegalovirus intravitreal subretinal eye irritation test cnv opthalmology veterinary opthalmology Show 18 more tags Show less

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Analytical Method Development

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following source. Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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Quality Control Method Development Method Validation Method Transfer QC testing Release Testing Analytical Method Development Show 7 more tags Show less

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Immunoassays

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource. Biologics: Comprehensive Services for Biologics Developers and Manufacturers Assay types include ADA screening, confirmatory, titration and isotyping, and neutralizing antibody (nAb). Please find the following resource. Safety:Investigational new drug development

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Immunoassays HCP Host cell proteins

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Analytical Method Validation

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X-ray Crystallography

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The structural biology team at Charles River carries out high-resolution structure determination by X-ray crystallography to support both stand-alone and integrated drug discovery projects. We have access to both in-house and synchrotron data collection facilities to provide fast turnaround and high-throughput structure... Show more »

The structural biology team at Charles River carries out high-resolution structure determination by X-ray crystallography to support both stand-alone and integrated drug discovery projects. We have access to both in-house and synchrotron data collection facilities to provide fast turnaround and high-throughput structure determination (including fragment screening campaigns).
Integration of protein production, crystallization and structure solution allows for efficient streamlining of the structure determination process. The resulting structures, combined with the significant industrial design experience of our crystallographers and integrated with results from advanced biophysical assays, allow us to detail protein-ligand interactions at a structural, kinetic and thermodynamic level and provide insight to drug design projects.

  • In-house X-ray facility with synchrotron access
  • Crystal bank of structures
  • Electron density maps
  • Scaled and merged diffraction data
  • Complete atomic coordinates
  • Structure interpretation
  • Ligand binding analysis (where appropriate)
  • Advice on medicinal chemistry design (where appropriate)
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X-ray crystallography

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Compound Profiling

Price on request

Identification of a compound‚Äôs target specificity and potential for off-target effects is a critical step in the drug discovery process and often includes assessments against specific target class families, critical safety targets or by therapeutic area. Charles River offers the largest collection of validated functional assays... Show more »

Identification of a compound’s target specificity and potential for off-target effects is a critical step in the drug discovery process and often includes assessments against specific target class families, critical safety targets or by therapeutic area. Charles River offers the largest collection of validated functional assays for ion channel selectivity profiling. Our ion channel portfolio includes over 120 assays, which have been organized into Channel Panels™ based on current scientific findings. We can provide functional, manual and automated ion channel screening by therapeutic area for profiling and risk assessment. Molecular target identification, or target deconvolution, is essential for understanding compound mechanism and further optimizing compounds of interest in the drug discovery pathway. Leverage CCMS, our proprietary technology for phenotypic screening target deconvolution.

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CCMS Ion Channel Selectivity Ion channel profiling

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Orthotopic Tumor Animal Models

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Orthotopic cancer models by Charles River were developed for use in the efficacy evaluation of novel anticancer compounds. Charles River offers the following orthotopic tumor models: Renal Sub-Capsule Orthotopic Model of Cancer; Intracranial Orthotopic Model; Intrasplenic Hepatic Colonization Model; Orthotopic Breast Tumor Model; Systemic Leukemia/Lymphoma Model

Orthotopic cancer models by Charles River were developed for use in the efficacy evaluation of novel anticancer compounds. Charles River offers the following orthotopic tumor models: Renal Sub-Capsule Orthotopic Model of Cancer; Intracranial Orthotopic Model; Intrasplenic Hepatic Colonization Model; Orthotopic Breast Tumor Model; Systemic Leukemia/Lymphoma Model

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Syngeneic tumor model xenograft tumor model

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Controlled Release Systems

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X-Ray Powder Diffraction

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Use X-ray crystallography to generate protein-ligand complexes that provide invaluable insights to your drug discovery teams. Charles River carries out high-resolution structure determination by X-ray crystallography to support both stand-alone and integrated drug discovery projects. We have access to both in-house and synchrotron... Show more »

Use X-ray crystallography to generate protein-ligand complexes that provide invaluable insights to your drug discovery teams. Charles River carries out high-resolution structure determination by X-ray crystallography to support both stand-alone and integrated drug discovery projects. We have access to both in-house and synchrotron data collection facilities to provide fast turnaround and high-throughput structure determination (including fragment screening campaigns). Protein Crystallization capabilities include: Robotic nanoliter-scale screening and imaging; Screening with known ligands; Automated optimization of conditions for crystal growth; Co-crystallization or soaking of ligands
X-ray crystallography capabilities include: Electron density maps; Scaled and merged diffraction data; Complete atomic coordinates; Structure interpretation; Ligand binding analysis (where appropriate); Advice on medicinal chemistry design (where appropriate)

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X-ray crystallography protein crystallization structural biology

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Animal Behavior Studies

Price on request

Anxiety/Depression
Forced Swim Test
Tail Suspension Test
Light/Dark Box
Cognition
-Novel Object Recognition (Natural Forgetting, Scopolamine -Induced Deficits, Phencyclidine Induced Deficits)
-Contextual Fear Conditioning
Motor Activity/Coordination
-Home Cage Locomotor Activity
-Open Field Test
-Rotorod
-Grip... Show more »

Anxiety/Depression
Forced Swim Test
Tail Suspension Test
Light/Dark Box
Cognition
-Novel Object Recognition (Natural Forgetting, Scopolamine -Induced Deficits, Phencyclidine Induced Deficits)
-Contextual Fear Conditioning
Motor Activity/Coordination
-Home Cage Locomotor Activity
-Open Field Test
-Rotorod
-Grip Strength
Psychosis/Mania
-Apomorphine Rearing/Climbing
-Psychostimulant Induced Locomotion
All behavior studies are carried out in mice or rats in our state of the art U.S. facility under review of an Institutional Animal Care and Use Committee. In addition to the array of pharmacologically validated assays, we strive to develop of new tests (in house or in collaboration with the sponsor). Given our expertise in microdialysis, all of our behavioral studies can be coupled to in vivo neurotransmitter monitoring via traditional microdialysis or with the use of biosensors.

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Animal Blood Collection

Price on request

Blood sampling is performed using automated Dilab AccuSamplers®
-Higher degree of precision and repeatability
-Sampling over prolonged periods of time
-Robust set-up for overnight operation
-Freely-moving and stress free conditions

Blood sampling is performed using automated Dilab AccuSamplers®
-Higher degree of precision and repeatability
-Sampling over prolonged periods of time
-Robust set-up for overnight operation
-Freely-moving and stress free conditions

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Particle Analysis and Characterization

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Animal Microsensor Studies

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Microsensoring has a higher spatial (10-25 μm diameter) and temporal resolution (second-scale recording of neurotransmitters) than microdialysis. Therefore, it can provide more spatial-temporal resolution measurements and capture the fast change neurotransmitter levels, glucose or other physiological compounds.

In our lab we... Show more »

Microsensoring has a higher spatial (10-25 μm diameter) and temporal resolution (second-scale recording of neurotransmitters) than microdialysis. Therefore, it can provide more spatial-temporal resolution measurements and capture the fast change neurotransmitter levels, glucose or other physiological compounds.

In our lab we routinely monitor brain glutamate and periphery glucose levels in both anesthetized and freely moving animals.

Currently we have sensors available for the monitoring of
-Lactic acid
-Glutamate
-Glucose
-NO
-H2O2
-Acetylcholine
-Choline

Sensors can be applied in
-Brain
-Spinal cord
-Subcutanous

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Dose Range Finding (DRF) Studies

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PCR

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource. Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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PCR qPCR qPCR Assay Quantitative Polymerase Chain Reaction

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In vitro Percutaneous Absorption Studies

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In Vitro Skin Corrosion Test

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Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Corrosion Assays:
SkinEthic EpiSkin® skin... Show more »

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River.

Skin Corrosion Assays:
SkinEthic EpiSkin® skin corrosion (OECD 431)
Corrositex® skin corrosion (OECD 435)
Acute dermal rodent

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Animal Plasma and Serum

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Animal Surgery

Price on request
  • Vascular Catherterizations
  • Non-Vascular Catheterizations
  • Soft Tissue Procedures
  • Neurological Procedures
  • Cardiovascular Procedures
  • Device Implants

Preconditioning services can help alleviate the space, time, and labor costs involved with refining a model to meet your unique research requirements. Whether you are... Show more »

  • Vascular Catherterizations
  • Non-Vascular Catheterizations
  • Soft Tissue Procedures
  • Neurological Procedures
  • Cardiovascular Procedures
  • Device Implants

Preconditioning services can help alleviate the space, time, and labor costs involved with refining a model to meet your unique research requirements. Whether you are looking for animals fed a special diet, altered through surgery, or reared to a certain age, Charles River has the state-of-the-art animal facilities, professional animal care, and robust model selection to deliver study-ready animals right to your door. Please find the following resources. RMS:Surgical Services and RMS:Labstamp animal identification

Charles River is AALAC certified.

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In vitro Skin Irritation/Sensitization Testing

Price on request

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River. Skin Sensitization Assays: * DPRA (direct peptide... Show more »

Many acute toxicity tests have been or are being effectively replaced by in vitro human, animal and 3D tissue alternatives. This shift is particularly evident in skin irritation, skin corrosion and skin sensitization models, all of which are fully supported at Charles River. Skin Sensitization Assays: * DPRA (direct peptide reactivity assay) * KeratinoSens and LuSens * MUSST * hCLAT * In silico (QSAR) * LLNA (local lymph node assay) * GPMT (guinea pig maximization test) * Buehler assay (contact sensitization) * DTH (delayed-type hypersensitization) Irritation Assays: * SkinEthic EpiSkin® skin irritation (OECD 439) * MatTek EpiOcular® eye irritation (OECD 492) * Bovine cornea and opacity permeability (BCOP – OECD 437) * Hen’s Egg Test (HET)-CAM ocular irritation * Ocular and dermal acute non-rodent * Acute dermal rodent

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Toxicology

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Drug Preformulation

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resource. Biologics: Comprehensive Services for Biologics Developers and Manufacturers

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formulation development Formulation Preformulation Drug Preformulation process development GMP Manufacturing Show 6 more tags Show less

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Bioanalysis

Price on request

With 12 laboratories around the world, we offer comprehensive bioanalytical services at every state of product development from discovery to post marketing studies. Our experienced scientists develop, validate and apply quantitative bioanalytical methods to measure drug and metabolite concentrations for both small and large... Show more »

With 12 laboratories around the world, we offer comprehensive bioanalytical services at every state of product development from discovery to post marketing studies. Our experienced scientists develop, validate and apply quantitative bioanalytical methods to measure drug and metabolite concentrations for both small and large molecules in all biological matrices. Please find the following resource. Safety:Bioanalysis

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LC-MS/MS Immunochemistry Mass Spectrometry bioanalysis Bioanalytical bioanalytical methods bioanalytical support metabolite concentrations LIMS capillary microsampling dry blood spot bioanalytical chemistry bioanalytical services DBS Show 14 more tags Show less

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Bioanalytical Analysis LC/MS/MS

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In vivo Biosafety Testing

Price on request

To help with safety evaluation, we provide in vivo biosafety (IVB) testing in our AAALAC-accredited laboratories according to GMP guidelines. IVB testing services include mouse/rat/hamster antibody production (MAP/RAP/HAP), inapparent virus assays, tumorigenicity testing and abnormal toxicity/general safety testing. Please find... Show more »

To help with safety evaluation, we provide in vivo biosafety (IVB) testing in our AAALAC-accredited laboratories according to GMP guidelines. IVB testing services include mouse/rat/hamster antibody production (MAP/RAP/HAP), inapparent virus assays, tumorigenicity testing and abnormal toxicity/general safety testing. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Drug Product Release

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Hamster Mouse Rat GMP Antibody Production Tumorigenicity MAP HAP inapparent virus general safety in vivo Biosafety testing RAP Vaccines Show 13 more tags Show less

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Product Quality Control

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Endocrine Disruptor Screening

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With new EPA endocrine disruptor regulations, proper testing is more important than ever. Whether you require Tier I or Tier II tests, our experts can help at every stage, from initial data gathering through evaluation and interpretation for hazard/risk assessment. All studies are validated and performed according to GLP... Show more »

With new EPA endocrine disruptor regulations, proper testing is more important than ever. Whether you require Tier I or Tier II tests, our experts can help at every stage, from initial data gathering through evaluation and interpretation for hazard/risk assessment. All studies are validated and performed according to GLP principles.

Sample capabilities:

  • In vitro assays
  • Androgen receptor binding
  • Aromatase (human recombinant)
  • Estrogen receptor binding
  • Estrogen receptor transcriptional activation
  • Steroidogenesis

In vivo assays:

  • Amphibian metamorphosis
  • Fish short-term reproduction
  • Hershberger
  • Pubertal female
  • Pubertal male
  • Uterotrophic
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Biochemistry & Molecular Biology

Price on request

Charles River performs a comprehensive array of genomics-based assays to support all phases of drug development, from discovery and preclinical studies through clinical trials, in either singleplex or multiplex formats. Please find the following resource. Safety: Laboratory Science

Charles River performs a comprehensive array of genomics-based assays to support all phases of drug development, from discovery and preclinical studies through clinical trials, in either singleplex or multiplex formats. Please find the following resource. Safety: Laboratory Science

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Endotoxin Testing

Price on request

The endotoxin testing performed by Charles River uses customer-requested methods for submitted samples. Our optimized formulations provide increased sensitivity, greater linearity, and superior interference resistance. Formulations are offered with a comprehensive range of buffers and accessories, providing numerous options for... Show more »

The endotoxin testing performed by Charles River uses customer-requested methods for submitted samples. Our optimized formulations provide increased sensitivity, greater linearity, and superior interference resistance. Formulations are offered with a comprehensive range of buffers and accessories, providing numerous options for resolving interferences with difficuit to test products. Please find the following resource.
Microbial: Endotoxin Testing

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Kinetic stability Stability Testing Chromogenic Turbidimetric LAL Limit Tests Depyrogenation On-Site Training Product Validation Routine Endotoxin Determination-Gel-clot Routine Endotoxin Determination-Turbidimetric Routine Endoctoxin Determination-Chromogenic Kinetic Product Release Testing Depyrogenation Validation SOP and Protocol Writing raw material in-process samples medical devices dialysis fluids chromogenic Kinetic cartridge technology gel-clot PTS Product Release final product semi-quantitative test dry heat dry-heat Gel-clot limit-test Gel-clot semi-quantitative test Turbidimetric Kinetic Chromogenic Endpoint Show 33 more tags Show less

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Protein Purification

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers, Biologics: Cell Banking and Storage and Biologics: Cell Line Characterization

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GMP Manufacturing Protein Purification Biopharmaceutical manufacturing

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Radiochemistry

Price on request
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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers, Biologics: Bioassay Services, Biologics: Cell Line Characterization, Biologics: Viral Clearance and TSE Clearance Studies, Biologics: Cell Banking and Storage and Biologics: Drug Product Release

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IND Submission IND BLA NDA NDA submission BLA submission regulatory submission Regulatory filing Show 8 more tags Show less

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Environmental Impact Assessment

Price on request

The Environmental Risk Assessment (ERA) service from Charles River is based on European guidelines; however, it can be applied to other submissions in differing countries and regulatory agencies. We have experience in ERA for all industry product sectors, including human pharmaceuticals.

The Environmental Risk Assessment (ERA) service from Charles River is based on European guidelines; however, it can be applied to other submissions in differing countries and regulatory agencies. We have experience in ERA for all industry product sectors, including human pharmaceuticals.

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Radiotracers and Radiopharmaceuticals

Price on request
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Integrated Drug Discovery

Price on request

Shorten times to IND with an integrated approach to drug discovery. Eliminate complicated logistics, increased administrative costs, and cycle time slippage by contracting with an organization that manages your project every step of the way.The industry standard from hit identification to development candidate nomination is on... Show more »

Shorten times to IND with an integrated approach to drug discovery. Eliminate complicated logistics, increased administrative costs, and cycle time slippage by contracting with an organization that manages your project every step of the way.The industry standard from hit identification to development candidate nomination is on average 33-36 months. Charles River’s truly integrated drug discovery programs have reduced this timeline to as little as 24 months through industry experienced, multi-disciplinary teams focused on resource efficiency, scientific excellence and strategic partnerships with clients through all aspects of drug discovery. With numerous technologies for hit identification, coupled with a knowledge-based approach to advance compounds from hit-to-lead into lead optimization, our scientific advisory services team consistently convert leads into successful preclinical development candidates.

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CNS/Neurology Lead optimization Hit Identification integrated drug discovery target discovery hit-to-lead Show 6 more tags Show less

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Regulatory Affairs Consulting

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Ex vivo Electrophysiology

Price on request

At Charles River, a variety of in vivo single-cell recording studies and brain slice electrophysiology are performed. In vitro / ex vivo patch clamp recording allows the direct measurement of neuronal activity of a single cell or channel (receptor) and is also used to quantify synaptic inputs from excitatory and inhibitory... Show more »

At Charles River, a variety of in vivo single-cell recording studies and brain slice electrophysiology are performed. In vitro / ex vivo patch clamp recording allows the direct measurement of neuronal activity of a single cell or channel (receptor) and is also used to quantify synaptic inputs from excitatory and inhibitory circuits in tissue obtained from living animals.
Multiplexed electrophysiological recordings from brain slices using multi-electrode arrays are a direct way to probe neural function, detect pathological functional abnormalities and explore sensitivity of spontaneous and evoked electrical signal transmissions to drugs. The recordings are a valuable tool in the study of synaptic plasticity, which is thought to underlie learning, memory and some brain pathologies. Up- or down-regulation of synaptic transmission can shed light on cellular and network mechanisms of numerous CNS diseases, including Alzheimer’s disease, autism and ataxia.

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Ion Channel Screening Assays

Price on request

Charles River works collaboratively with our partner to enable them to translate ion channel discoveries into tomorrows therapeutics in a timely and cost effective manner. As your scientific partner, we work to provide innovation through new assays and cell lines,  flexibility with our screening services or cell lines for in-house... Show more »

Charles River works collaboratively with our partner to enable them to translate ion channel discoveries into tomorrows therapeutics in a timely and cost effective manner. As your scientific partner, we work to provide innovation through new assays and cell lines,  flexibility with our screening services or cell lines for in-house efforts and efficiency in the drug development process.  Capabilities include:  - Assay development and transfer  - Fluorescence-based screens of up to 700,000 compounds (FLIPR¬Æ / Hamamatsu FDSS)  - IonWorks¬Æ Quattro and IonWorks¬Æ Barracuda‚Ñ¢ screens of up to 125,000 compounds per target (voltage-gated and ligand-gated ion channels)  - Conventional as well as PatchXpress¬Æ and QPatch HT¬Æ automated electrophysiology for detailed pharmacological and biophysical follow-up studies  - Ion channel selectivity profiling  - Computational chemistry for knowledge-based compound deck selection from our 850,000 diverse compound library  - Hit-to-lead and lead optimization support using fluorescence-based, automated and conventional electrophysiology  - GLP hERG and related cardiac safety liability studies. Please find the following resources. Discovery: Ion Channel Screening and Discovery: Ion Channel Portfolio

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Hamamatsu FDSS/μCell IonWorks® Quattro IonWorks® Barracuda™ PatchXpress® QPatch HT® ion channels ion channel screening in vitro biology Drug Discovery FLIPR FDSS Quattro PatchXpress QPatch Drug Discovery Show 15 more tags Show less

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Biomolecular Interaction Analysis

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Biacore biomolecular interaction analysis

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Biopharmaceutical Manufacturing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers, Biologics: Bioassay Services, Biologics: Cell Line Characterization, Biologics: Viral Clearance and TSE Clearance Studies, Biologics: Cell Banking and Storage and Biologics: Drug Product Release

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GMP Manufacturing Biopharmaceutical manufacturing biologics vaccines biosimilars

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Safety Pharmacology

Price on request

Understanding and mitigating the potential risks your program faces are crucial to a successful IND submission. Our comprehensive, global and harmonized safety pharmacology program complies with International Conference on Harmonisation (ICH) Guidelines (S7A, S7B) and provides the expert interpretations needed to advance your... Show more »

Understanding and mitigating the potential risks your program faces are crucial to a successful IND submission. Our comprehensive, global and harmonized safety pharmacology program complies with International Conference on Harmonisation (ICH) Guidelines (S7A, S7B) and provides the expert interpretations needed to advance your program successfully. Please find the following resource. Safety: Safety Pharmacology

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Safety Pharmacology MPI Research safety pharmacology studies safety pharmacology models ICH S7A ICH S7B core battery test drug safety in vivo research pharmacology program cardiovascular drugs Pharmacology Show 12 more tags Show less

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Liver Fibrosis Animal Models

Price on request

No single animal model accurately recapitulates the histopathology and metabolic profile of nonalcoholic steatohepatitis (NASH), but several have been identified that simulate the disease. Charles River capabilities include two animal models of NASH: Choline Deficient, Defined Amino Acid (CDAA) Mice; High Fructose, High Fat, Cholesterol Diet in ob/ob Mice

No single animal model accurately recapitulates the histopathology and metabolic profile of nonalcoholic steatohepatitis (NASH), but several have been identified that simulate the disease. Charles River capabilities include two animal models of NASH: Choline Deficient, Defined Amino Acid (CDAA) Mice; High Fructose, High Fat, Cholesterol Diet in ob/ob Mice

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Non-Alcoholic Steatohepatitis (NASH) NASH Nonalcoholic Steatohepatitis Models

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Functional Human Tissue Assays

Price on request
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Mammalian Cell Culture

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Mammalian Cell Culture Cell Line Characterization Cell Banking

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Gas Chromatography (GC)

Gas Chromatography
Price on request
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Gene Therapy Development

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine,gene and cell therapy and biosimilar development. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Drug Product Release

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Gene Therapy AAV testing Cell Therapy

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Medical Device Testing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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GMP

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Clinical Laboratory Services

Price on request
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Microbiology Testing

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please find the following resources. Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Drug Product Release

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endotoxin USP EP Sterility Microbiology testing GMP microbiology Show 6 more tags Show less

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IND-Enabling Studies

Price on request

Learn through our years of IND research experience, unique range of services and best-in-class expertise how we can help you successfully initiate and complete your IND-enabling program. With our ongoing efforts to improve upon our internal processes and continued focus on scientific excellence and guidance, we are pleased to... Show more »

Learn through our years of IND research experience, unique range of services and best-in-class expertise how we can help you successfully initiate and complete your IND-enabling program. With our ongoing efforts to improve upon our internal processes and continued focus on scientific excellence and guidance, we are pleased to offer a highly cost-effective IND program for our clients. Please find the following resource. Safety:IND E-Guide

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IND-Enabling Studies IND Submission Investigative New drugs Exploratory IND studies

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Scientific Sourcing

Price on request

The Charles River RightSourceTM scientific staffing program is a flexible insourcing/outsourcing option for biologics developers and manufacturers. The RightSourceTM program removes the challenges of externalizing your biologics testing by providing customized options that allow you to maintain as much or as little control over... Show more »

The Charles River RightSourceTM scientific staffing program is a flexible insourcing/outsourcing option for biologics developers and manufacturers. The RightSourceTM program removes the challenges of externalizing your biologics testing by providing customized options that allow you to maintain as much or as little control over your in-house resources, capital assets and facilities that you consider strategic and cost efficient. We work with you to evaluate your quality control (QC) testing programs by reviewing your current testing structure and selecting the best-suited and most cost-efficient mix of insourcing and outsourcing options. Combining 20 years of experience in facility management, staffing and consulting services with a long-standing history of operating quality control testing laboratories makes Charles River the best choice for your scientific staffing needs.

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QC testing QC services Outsourcing Insourcing Project management Staffing QC management Show 7 more tags Show less

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Regulatory Affairs Services

Price on request
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High Throughput Screening (HTS)

Price on request
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Antibody Services

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Antibody Production antibody manufacturing Antibodies Proteins Monoclonal antibodies polyclonal Antibodies Show 6 more tags Show less

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Antibody-Drug Conjugate (ADC) Analysis

Price on request

Charles River provides a broad array of analytical services designed to deliver a complete set of analytical solutions for antibody-drug conjugate (ADC) development and testing. We have worked on many conjugate projects across multiple biologic drug-conjugate technologies for some of the leading ADC product developers, including: ... Show more »

Charles River provides a broad array of analytical services designed to deliver a complete set of analytical solutions for antibody-drug conjugate (ADC) development and testing. We have worked on many conjugate projects across multiple biologic drug-conjugate technologies for some of the leading ADC product developers, including: Antibody-Drug Conjugates, Protein-Drug Conjugates, Antibody-Peptide Drug Conjugates, Peptide-Drug Conjugates Services for ADCs, and other conjugated products include: Drug-to-Antibody Ratio (DAR) Determination Site Occupancy via Mass Spectrometry Experience with Key Conjugation (Linker) Technologies Analysis of Free Drug (Payload) and Naked Carrier Protein / Antibody Confirmation of Secondary Structure and Aggregation (HOS) Extensive Method Development and ICH Validation Capabilities Methods for Quantifying Drug-Conjugate Components for PK and PD Studies Mapping of PTMs, Disulfide Bonds and Glycosylation cGMP Lot Release and Stability Testing Reference Standard Characterization Solubility Studies, Pre-formulation and Formulation Development Forced Degradation Degradants, Impurities and Isoform Characterization Bridging Studies and Comparability Programs

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ADCs ADC Anti-drug Conjugates Protein-Drug Conjugates Anti-peptide Drug Conjugates Peptide-Drug Conjugates Show 6 more tags Show less

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CAR-T Cell Therapy Development

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Immuno-Oncology

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Cell Banking

Price on request

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and... Show more »

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and can provide the appropriate cell storage services, all under Good Manufacturing Practice (GMP) guidelines. Our capabilities include purity, sterility, identity, genetic stability testing and an array of other characterization assays from our expansive testing portfolio. Our experienced technical staff can customize a project to create and characterize master cell banks, working cell banks, research cell banks, end-of-production cells and cells at the limit of in vitro cell age, according to client specifications. Please find the following resources.
Biologics: Cell Banking and Storage

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Yeast stem cells insect cells Mammalian cells Microbial cells GMP Bacteria Show 7 more tags Show less

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Cell Culture Consulting

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Yeast stem cells insect cells Mammalian cells Microbial cells GMP Bacteria Show 7 more tags Show less

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Cell Line Characterization

Price on request

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and... Show more »

Cell lines must be tested for the presence of general and specific contaminants to ensure the safety of the associated biological product. Our team collaborates with clients to develop scientifically sound and cost-effective cell bank programs. We manufacture cell banks for mammalian, microbial, insect, yeast and stem cells and can provide the appropriate cell storage services, all under Good Manufacturing Practice (GMP) guidelines. Our capabilities include purity, sterility, identity, genetic stability testing and an array of other characterization assays from our expansive testing portfolio. Our experienced technical staff can customize a project to create and characterize master cell banks, working cell banks, research cell banks, end-of-production cells and cells at the limit of in vitro cell age, according to client specifications.
Please find the following resources.
Biologics: Cell Line Characterization

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Purity Assay Copy Number GMP Mycoplasma Detection Sterility Microbial Contamination Cell Line Identification STR analysis DNA fingerprinting Barcode analysis Restriction Endonuclease Analysis bacteriophage testing viability testing DNA sequencing retention of recombinant construct retention of selectable markers Genetic Stability 165 rDNA Sequencing Adventitous Agent Testing Virology Contamination Show 20 more tags Show less

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Assay Development Consulting

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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assay development assay method development Assay Method validation Assay Method feasibility

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Nucleic Acid Services

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development

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Nucleic Acids RNA Bioanalytical Nucleic Acid Services

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Cell-Based Screening Methods

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Cell-based assays Cell-Based Screening Methods Custom Cell-Based Assay Development

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Glycosylation Analysis

Price on request

Charles River offers an expert panel of services for the characterization of glycosylation. We specialize in comparability programs that may be used for manufacturing/process changes and for comparisons of originator vs. biosimilar products. Glycosylation Site Occupancy and Mapping via Peptide Mapping LC-MS/MS N-Linked... Show more »

Charles River offers an expert panel of services for the characterization of glycosylation. We specialize in comparability programs that may be used for manufacturing/process changes and for comparisons of originator vs. biosimilar products. Glycosylation Site Occupancy and Mapping via Peptide Mapping LC-MS/MS N-Linked Oligosaccharide Profile via LC-MS/MS O-Linked Oligosaccharide Profile via LC-MS/MS Quantitative Monosaccharide Analysis Quantitative Sialic Acid Determination Glycan Structural Characterization / Confirmation via MS Glycan Profile / Isoform via cIEF Exoglycosidase Glycan Sequence / Mapping

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GMP Glycosylation oligosaccharide profile monosaccharide analysis sialic acid determination Glycosulation site Show 6 more tags Show less

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Host Cell Protein (HCP) Detection

Price on request

The presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. With over 30 years of combined experience, our team of host cell protein experts assists clients in the development of a downstream process with the use of effective assays to determine both the concentration of the... Show more »

The presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. With over 30 years of combined experience, our team of host cell protein experts assists clients in the development of a downstream process with the use of effective assays to determine both the concentration of the product and the quantity and concentration of host cell proteins present. The assays used accurately monitor changes in the product concentration and the removal of host cell proteins after purification.

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GMP ELISA-based assay HCP assay Mass Spectrometry

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Viral Assays

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Cell-based assays virology Viral Assays

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Liposome Characterization

Price on request

Charles River has extensive experience supporting liposomal product characterization as well as release testing and stability program management for liposomal products. Our liposomal product characterization services include all technologies used to characterize the active biologic or small molecule.
Liposomal product... Show more »

Charles River has extensive experience supporting liposomal product characterization as well as release testing and stability program management for liposomal products. Our liposomal product characterization services include all technologies used to characterize the active biologic or small molecule.
Liposomal product characterization services include:

  • Liposome characterization for analysis for identity, purity and quantitation of the lipid components
  • Analysis for identity, purity and quantitation of the active pharmaceutical ingredients (APIs)
  • Liposomal encapsulation efficiency
  • In vitro release testing
  • Method development for extraction and quantification of API, including peptide drug products
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Protein Characterization Liposome Characterization Liposome Product Characterization

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Monocyte Activation Testing

Price on request

Reflecting our strong commitment to the 3Rs, Charles River continuously seeks new methods and technologies to provide clients with viable in vitro alternatives to in vivo tests. In this accord, we offer the monocyte activation test (MAT) according to EP 2.6.30. The MAT works by predicting the human response to pyrogens on the... Show more »

Reflecting our strong commitment to the 3Rs, Charles River continuously seeks new methods and technologies to provide clients with viable in vitro alternatives to in vivo tests. In this accord, we offer the monocyte activation test (MAT) according to EP 2.6.30. The MAT works by predicting the human response to pyrogens on the basis of human fever, and may be used as an alternative to the rabbit pyrogen test. This assay can be used to detect Gram-positive and Gram-negative organisms and parasitic, viral and other biological pyrogens (e.g., yeast). It also offers a solution for the testing of products that prove problematic in other in vitro endotoxin tests, such as drugs that affect body temperature regulation (e.g., antipyretic drugs and steroids), drugs that cause immunological reactions (e.g., immunoglobulins), detergents, some blood-derived products (e.g., stem cells) and other products that are turbidimetric, strongly colored or interfere with clotting.

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GMP in vitro Monocyte activation testing MAT

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Pyrogen Testing

Price on request

In addition to services in biological testing and quality control, Charles River offers rabbit pyrogen testing according to GMP standards. In this assay, the body temperatures of a sampling of rabbits are measured over a period of time following exposure to a test article. An elevated temperature in the rabbits indicates the... Show more »

In addition to services in biological testing and quality control, Charles River offers rabbit pyrogen testing according to GMP standards. In this assay, the body temperatures of a sampling of rabbits are measured over a period of time following exposure to a test article. An elevated temperature in the rabbits indicates the presence of pyrogenic compounds within the test article. In vivo pyrogen tests are carried out on specific pathogen-free (SPF) rabbits. Testing is available at multiple facilities and can be performed according to USP<151>, EP 2.6.8 and JP 4.04 for release into the United States, Europe and Japan. With over 30 years of experience, Charles River performs more than 2,500 rabbit pyrogen tests per year and is able to provide results 7-10 days after sample receipt.

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Rabbit GMP in vivo Pyrogen testing

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Residual DNA Analysis

Price on request

Charles River can detect and quantify minute amounts of residual host cell DNA by using three highly sensitive, validated methods. These methods encompass the entire range of residual DNA from nonspecific detection of total DNA to highly specific detection of single target sequences.

Charles River can detect and quantify minute amounts of residual host cell DNA by using three highly sensitive, validated methods. These methods encompass the entire range of residual DNA from nonspecific detection of total DNA to highly specific detection of single target sequences.

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GMP Hybridization Assay Threshold Assay qPCR Assay

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Viral Clearance Assays

Price on request

All manufacturers of biologics are required to assess the ability of the manufacturing process to generate a product safe for human use. Therefore, a viral clearance study is performed to evaluate key steps of the manufacturing process to ensure that it is effective at removing or inactivating viruses. Our scientists have... Show more »

All manufacturers of biologics are required to assess the ability of the manufacturing process to generate a product safe for human use. Therefore, a viral clearance study is performed to evaluate key steps of the manufacturing process to ensure that it is effective at removing or inactivating viruses. Our scientists have extensive experience in the design and performance of viral clearance studies, including transmissible spongiform encephalopathy (TSE) clearance, for a wide range of products. We take a customized approach that includes advice and regulatory support in the selection of process steps and model viruses, scaling-down of purification processes and subsequent design of study protocols to ensure a successful program is established and reported to meet timelines.
Please find the following resources.
Biologics: Viral Clearance and TSE Clearance Studies

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qPCR western blot TSE Clearance Infectivity assay viral clearance DNA Enveloped DNA non-Enveloped RNA Enveloped RNA Non-Enveloped Show 9 more tags Show less

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Western Blot

Price on request

Blotting of proteins or peptides, commonly named 'Western blotting', is the method of choice whenever information is needed on protein identification and protein quantitation. Western blotting can be used a biochemical quantitation method and a topographical localization technique. Western blotting can be performed both on... Show more »

Blotting of proteins or peptides, commonly named 'Western blotting', is the method of choice whenever information is needed on protein identification and protein quantitation. Western blotting can be used a biochemical quantitation method and a topographical localization technique. Western blotting can be performed both on freshly prepared brain-slices and on homogenized brain-tissue. After tissue sample homogenization and they can be subjected to a number of separation treatments to select, for example membrane bound proteins or cytoplasmic proteins. After poly acrylamide gel electrophoreses and transferal to a membrane antibodies can be used to detect and quantify a protein/receptor of interest.

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western blot protein quantification Protein Identification

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Feasibility Studies

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Method Development Feasibility Studies Method Feasibility Method Evaluation

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Impurity Analysis

Price on request

The characterization of the purification process is a key part of the chemistry and manufacturing controls (CMC) section of regulatory filings. In support of quality by design for any process, testing of residual process impurities is an integral step. We support testing of all process stages for impurities such as residual... Show more »

The characterization of the purification process is a key part of the chemistry and manufacturing controls (CMC) section of regulatory filings. In support of quality by design for any process, testing of residual process impurities is an integral step. We support testing of all process stages for impurities such as residual Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin and host cell proteins. In addition to generic methods, we offer transfer or method development and validation for customized, product-specific methods.

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Impurity Analysis HPLC Mass Spec PCR ELISA N-terminal Sequencing Residuals Analytical Ultracentrifugation Peptide mapping HCP assay process-related residuals Show 11 more tags Show less

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Chromatography

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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HPLC UPLC GMP Gas Chromatography GC Liquid Chromatography Chromatography LC Analytical Show 9 more tags Show less

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Separation/Purification Services

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Separation Purification Services Impurities

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Residual Impurity Analysis

Price on request

In the course of product manufacturing, a number of chemicals are typically added upstream to improve on product expression, recovery, etc. These chemicals are almost entirely removed during the downstream purification process; however, residual levels of these agents may be left within the bulk drug substance and drug product. To... Show more »

In the course of product manufacturing, a number of chemicals are typically added upstream to improve on product expression, recovery, etc. These chemicals are almost entirely removed during the downstream purification process; however, residual levels of these agents may be left within the bulk drug substance and drug product. To ensure that the residual level of these agents is within safe amounts, highly sensitive analytical methods have been developed to detect and quantify such residuals. Charles River offers a full spectrum of ready-to-use analytical methods for the detection and quantification of process- and product-related residuals and impurities.

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HPLC ELISA LC-MS/MS Analytical SEC GMP LC-MS N-terminal Sequencing Analytical Ultracentrifugation Peptide mapping process-related residuals product-related impurities CAD Detector ELSD Show 13 more tags Show less

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Biopharmaceutical Development

Price on request

With decades of success in building biologics, Charles River is likewise an ideal partner in the development of biosimilars. We deliver client-focused solutions for the specific testing and manufacturing requirements of biosimilars. Services include cell bank creation, characterization and storage, biosafety testing, process... Show more »

With decades of success in building biologics, Charles River is likewise an ideal partner in the development of biosimilars. We deliver client-focused solutions for the specific testing and manufacturing requirements of biosimilars. Services include cell bank creation, characterization and storage, biosafety testing, process evaluation for viral clearance, originator and biosimilar product characterization, including mass spectrometry, originator and biosimilar unstressed and forced degradation comparability studies, stability studies, equivalence studies, bioassays and product release testing. In addition, as a contract research organization with true end-to-end capabilities, our Safety Assessment team can enhance efficiencies by providing the necessary services with a range of tests to support the development process. These can include toxicology studies to demonstrate biosimilarity, analytical (dose formulation analysis) and bioanalytical assays (toxicokinetics and immunogenicity), immunohistochemistry (e.g., tissue-cross reactivity) and immunology (e.g., flow cytometry and other biomarkers as appropriate).

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GMP Biosimilarity analysis Cytokines Hormones mABs

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Cytotoxicity Assays

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Cytotoxicity Assays

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Vaccines

Price on request

As part of the Charles River vaccine program, we draw from our global scientific network to provide vaccine companies with considerable flexibility and convenience in the development of their products. We manufacture both live and attenuated viral vaccines and challenge viruses in cell-based expression systems under GMP... Show more »

As part of the Charles River vaccine program, we draw from our global scientific network to provide vaccine companies with considerable flexibility and convenience in the development of their products. We manufacture both live and attenuated viral vaccines and challenge viruses in cell-based expression systems under GMP requirements for both preclinical studies and early-phase clinical trials. We offer testing from release of cell banks and viral stocks to the release of bulk and final vaccine products.

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Influenza Potency Assay GLP GMP Reproductive Toxicology Immunogenicity Studies Contamination Testing in vivo Immunotoxicology formulation development safety assessment efficacy testing immunology challenge studies virus manufacturing dose response biodistribution virology Vaccine Testing Services Microbiology Respiratory Syncytial Virus (RSV) Tunorigenicity Show 22 more tags Show less

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Formulation Services

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Charles River has expertise in the development of liquid formulations of proteins, peptides and other biologics products. Our formulation experience includes: Various routes of administration, such as IV, IM depot and ocular, several of which required high-concentration formulations Typically insoluble molecules Stability-indicating assays Forced degradation studies Accelerated stability studies Photostability testing Complex proteins Multi-peptide formulated therapeutics

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Manufacturing Services

Price on request

All products entering domestic or global pharmaceutical markets require GMP testing to ensure that they are released in accordance with approved specifications. Release testing packages include a range of studies previously validated to demonstrate compliance of the product. Charles River provides release testing services for... Show more »

All products entering domestic or global pharmaceutical markets require GMP testing to ensure that they are released in accordance with approved specifications. Release testing packages include a range of studies previously validated to demonstrate compliance of the product. Charles River provides release testing services for bulk drug substances, as well as clinical and marketed products for the EU, US and other regulatory-distinct markets, and can unify global release testing with a single provider. We provide a full range of support, including analysis using suitable in vivo and in vitro potency assays, analytical and microbiology tests, and pyrogen and monocyte activation testing (MAT) to determine purity, identity and other biochemical and biophysical characteristics. We develop and produce monoclonal antibodies by production of hybridomas. We can offer our standard services or customize development and production services based on client needs. We can also offer polyclonal antibody production services such as antigen synthesis, purification, and analysis. In addition, we can design studies in terms of number of immunizations, duration, sample bloods, analysis, etc. to meet each customer's needs.
Please find the following resources.
Biologics: Comprehensive Services for Biologics Developers and Manufacturers
and
Biologics: Drug Product Release

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GLP GMP Drug Product Release virus manufacturing Cell Banking Vaccine Manufacturing Monoclonal Anbtibody (mAB) Production Lot Release testing Chemistry Manufacturing and controls (CMC) IND BLA nonGMP Polyclonal Antibody Production Show 14 more tags Show less

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Product Development, Testing, and Packaging

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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GMP photostability stability Stability Testing Stability Storage QC testing Release Testing Product Development Accelerated Stability Testing ICH Accelerated Stability ICH Stability Testing Product Quality Control product stability testing Product Testing Services analytical testing Show 16 more tags Show less

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Spectrophotometry

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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spectrophotometry

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Genetically Engineered Mice

Price on request

Charles River provides off-site space for holding, breeding, and developing genetically engineered mouse and rat colonies. All colonies are assigned a dedicated project manager and clients are granted access to Charles River’s innovative Internet Colony Management (ICM™) system. Whether you want to simply maintain a line, produce... Show more »

Charles River provides off-site space for holding, breeding, and developing genetically engineered mouse and rat colonies. All colonies are assigned a dedicated project manager and clients are granted access to Charles River’s innovative Internet Colony Management (ICM™) system. Whether you want to simply maintain a line, produce regular animal shipments for your studies, or backcross your strain to a different genetic background, each breeding colony is scalable to your specific research needs.
Our Isolator-based animal quarantine facilities allow for the direct acceptance of animals from any institution worldwide, regardless of their known or unknown health status. This flexibility provides options to screen animals that would otherwise not be allowed into many animal facilities and speed up the process of acquiring valuable research animals. At the completion of the quarantine period, animals that are proven negative of excluded agents are allowed directly into most barrier facilities without the need to rederive.
Charles River works with global customers on unique transgenic models to deliver study-ready cohorts to meet research needs. Our dedicated project management team, scientists, and animal care staff are always available to offer guidance, develop work plans, and help overcome any challenges. Through partnerships with genomics industry leaders, our combined expertise provides an optimum environment for generating, characterizing, preserving, and distributing your transgenic lines.

Please see the following resources. GEMS:rederivation services , GEMS:Rapid Quarantine , GEMS:Line rescue services , GEMS:Transgenic models creation through colony expansion , GEMS:Model Creation , GEMS:Transgenic Model and Service

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Mouse Rat MEA RNAi mutagenesis ES cell Knockin Mice Knockout Mice Model Creation Cryopreservation MAX-BAX Breeding services Quarantine Services Trangenic Model Creation Model creation Products and Services Rederivation Services Cryopreservation Services Cryorecovery services Assisted Reproduction Services rat breeding mouse breeding rat and mouse breeding rodent colony management Quarantine Isolator quarantine Transgenic model creation genomics CRISPR/Cas9 genome editing microinjection services DNA transgeneis transgenes SNP modification ES Cell Injection CRISPR Injection plasmid BAC DNA blastokit embryos sperm rederivation IVF IVF rapid expansion embryo rederivation embryo cryopreservation sperm sperm cryopreservation germplasm cryostrorage cryostorage cryorecovery reconstitution embryo reconstitution sperm reconstitution reproduction services assisted reproduction mouse rescue mouse embryo assay human sperm assay HAS Show 58 more tags Show less

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Laboratory Animal Genetic Quality Control

Price on request

Genotyping that is conducted routinely can help keep colony sizes manageable, aid in selecting animals for study cohorts, and set aside animals for future breeding. Our high-throughput, multi-platform genotyping laboratory delivers results from sample receipt to facilitating more efficient lab animal colony management.
Assay... Show more »

Genotyping that is conducted routinely can help keep colony sizes manageable, aid in selecting animals for study cohorts, and set aside animals for future breeding. Our high-throughput, multi-platform genotyping laboratory delivers results from sample receipt to facilitating more efficient lab animal colony management.
Assay development and genetic quality control (GQC) work in conjunction to help identify contamination early and keep your lines in check. Assays are custom designed based on the information you provide to ensure specificity of allele detection and accurate genotype determinations. Each protocol is reviewed by our expert team of scientists. Our scientists will work with you to help resolve any issues and deploy new breeding strategies to overcome any challenges that may arise.
Genetic background characterization alerts you to genetic variation, which may eventually arise even in closed breeding programs, as well as via the introduction of contaminating genetic backgrounds through misbreeding. Charles River has microsatellite and SNP panels appropriate for the genetic monitoring of any inbred strain of mouse or rat, from detecting a genetic contamination to fine-mapping a transgene insertion point.
Marker-assisted accelerated backcrossing (MAX-BAX®) could save a year and a half or more of breeding by screening the background strain genetics of your research animals and selecting those with the highest percentage of the desired background. Our MAX-BAX® service is a custom microarray platform that utilizes robust fluorescence-based assays. The 384 SNP marker screens are strategically spaced across the genome to analyze common polymorphisms found between inbred strains.
Expression profiling data has proven useful in safety lead optimization and dose-limited toxicity studies, yielding insights sometimes not gleaned from traditional methods. Charles River offers low- and mid-density mouse and rat gene expression testing using pre-validated TaqMan® gene expression assays from Life Technologies.
PCR-based screening services for CRISPR/Cas9-generated models quickly and accurately identifies which founders or cell lines carry mutations with small INDELS at the intended targeting site. Our PCR analysis platform based on microfluidic, laser-induced fluorescence technology allows sensitive detection of heteroduplex formation when small INDELs are present, which is the basis for T7 endonuclease digestion, the most commonly used screening method for CRISPR/Cas9 generated mutations. This PCR platform combined with our proprietary assays produce cleaner data compared to T7 digestion, which often produces background noise, making mutation detection ambiguous.

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assay development Gene expression profiling assay validation CRISPR Cas9 gene expression SNP Genotyping Assay Development and Genetic Quality Control Background Strain Characterization MAX-BAX Cogenic Strain Production strategies Expression testing strain-specific genetic variation zygosity testing mutations gene targeting ES cells transgenic carriers transgene segregation instability gene targeted screening colony management genentic quality control GQC SNP Analysis Genotyping services genentic background speed congenics phenotype congenic strain production MAX-BAX congenic strain marker-assisted accelerated backcrossing espression testing expression profiling gene expression testing TaqMan CRISPR/Cas9 CRISPR-Cas9 INDELS PCR analysis heteroduplex formation PCR-based screening PCR based screening Show 44 more tags Show less

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Laboratory Animal Monitoring

Price on request

360 Diagnostics

Our diagnostic laboratory is a full-service rodent and rabbit necropsy laboratory with a complete spectrum of specialized services, including infectious disease PCR, serology, microbiology, pathology, and parasitology. We offer testing services on multiple laboratory animal species for both routine... Show more »

360 Diagnostics

Our diagnostic laboratory is a full-service rodent and rabbit necropsy laboratory with a complete spectrum of specialized services, including infectious disease PCR, serology, microbiology, pathology, and parasitology. We offer testing services on multiple laboratory animal species for both routine surveillance and diagnosis of diseases.Using Multiplexed Fluorometric ImmunoAssay® (MFIA®), Charles River's primary serology testing method, allows our lab to test multiple strains of a single pathogen as well as incorporate system and sample suitability controls for increased sensitivity and accuracy. Available profiles include mouse, rat, hamster, guinea pig, rabbit, gerbil, simian, custom profile, and single agent assay upon request.Our microbiology services incorporates MALDI-TOF mass spectrometry analysis for screening bacterial species that are primary pathogens as well as a select group of bacteria that are considered to be important opportunistic agents. Screening can be completed as part of whole live animal health monitoring or from individual samples collected at your facility and submitted to us. Microbiological analysis is available for mice, rats, hamsters, guinea pigs, gerbils, rabbits, zebrafish, ferrets, and nonhuman primates.Endo- and ectoparasites continue to be a significant concern for laboratory animal facilities. Charles River offers multiple screening methods for the detection of parasites in rodent, rabbit, and large animal colonies. Samples (e.g., feces, swabs, tapes) collected at your facility can be submitted directly to our laboratory for testing. We can also work directly with you to develop a testing regimen that supplements your health monitoring program.Charles River offers you the flexibility of outsourcing any part of your pathology requirements. The laboratory is overseen by ACVP board-certified veterinary pathologists and offers custom protocol design and rapid report turnaround. Our services range from routine diagnostic assessment to pathology support as part of your in-house research studies.We offer comprehensive diagnostic testing services for both pre-export testing and health monitoring of your nonhuman primate (NHP) colonies. Please note that these testing services are available for samples only. Our health monitoring services are fully customizable to meet your specific program requirements. Please find the following resources. RMS:360 Diagnostics , RMS:GE-DS Simian Testing Services , RMS:Zebrafish Testing Services , RMS:Ferret Health Surveillance , RMS: Culture Technical Sheet and RMS:Next generation Sequencing

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Hamster Rabbit Guinea pig Ferret Mouse Rat Zebrafish Gerbil Non-human primates (NHP) PCR ELISA Next Generation Sequencing histology NGS MALDI-TOF Environmental Monitoring RODAC Serology Animal Health Surveillance Serology Profiles Microbiology Culture Rodent and Rabbit Parasitology Necropsy and Histology Services Simain (Non Human Primate) Health Surveillance Zebrafish Health Surveillance Ferret Health Surveillance Serology Reagents for in-house Animal Health Surveillance Clear-cell line Research Biologics screening Microbiome Diagnostic Services health Monitoring alternative health monitoring health surveillance PRIA EAD FELASA MFIA Multiplexed fluorometric immunoassay IFA Indirect Fluorescent Anitbody Enzyme-linked immunosorbent assay mouse serology HemaTIP Blood microsampler rat serology hamster serology guinea pig serology rabbit serology gerbil serology rodent serology upper respiratory culture gastrointestinal tract culture microbiology services surface testing rodent parasitology rabbit parasitology rat parasitology mouse parasitology necropsy diagnostic pathology clinical pathology simian health surveillance simian health monitoring nonhuman primate health monitoring simian macaque baboon african green Flavivirus serology reagants in-house health surveillance indirect fluorescent antibody Clear PCR Panel CLEAR Rodent infectious agent human infectious agent customized panel Germ-free microbiome microbial cultures animal monitoring Show 81 more tags Show less

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Animal Model Housing and Maintenance

Price on request

Due to the challenges inherent in researching and developing anticancer therapeutics, it is important that you have the right tools and resources available to you. Furthermore, selecting the most appropriate animal model is a critical step when designing an oncology study.Preconditioning services can help alleviate the space,... Show more »

Due to the challenges inherent in researching and developing anticancer therapeutics, it is important that you have the right tools and resources available to you. Furthermore, selecting the most appropriate animal model is a critical step when designing an oncology study.Preconditioning services can help alleviate the space, time, and labor costs involved with refining a model to meet your unique research requirements. Whether you are looking for animals fed a special diet, altered through surgery, or reared to a certain age, Charles River has the state-of-the-art animal facilities, professional animal care, and robust model selection to deliver study-ready animals right to your door.With more than 20 breeding facilities around the world, Charles River is the leading global supplier of standard rat models for biomedical research. Charles River stocks and strains are managed under the International Genetic Standardization (IGS) program, a unique program designed to manage the health and genetics of outbred and inbred strains on a global basis, ensuring that researchers worldwide have access to standardized models, regardless of the production location.Because most diseases cause a wide range of complications, their study is complex and often requires research programs to take a multidisciplinary approach. Therefore, aside from mouse and rat models, we also provide other species of research models in order to support your program requirements.

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Hamster Rabbit Guinea pig Mouse Rat Gerbil Rat Model Mouse Model Immunodeficient Models Guinea pig, hamster, Gerbil, and Rabbit Models Preconditioning services rats inbred rats outbred rats hybrid rats immunodeficient rats nude rats mice inbred mice outbred mice hybrid mice germ-free mice immunodeficient mice nude mice SCID mice congenic mice Coisogenic mice oncology mice humanized mice microbiome mice hartley guinea pigs hairless guinea pigs LVG Golden Syrian Hamsters Mongolian gerbils NZW Rabbits NZW Research models and services surgical services vascular catheterizations catheterizations catheter soft tissue procedures neurological procedures cardiovasular procedures device implants surgical support Pre-ID Pre-Screening Pre-Dosing Pre-Injection Custom Diets aging study phenotypic evaluations biospecimens blood products serum whole blood organs tissues Show 59 more tags Show less

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Free Amino Acid Analysis

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. Please see the following resources Biologics: Comprehensive Services for Biologics Developers and Manufacturers and Biologics: Drug Product Release

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Amino Acid Analysis Extinction Coefficient analytical testing AAA hydrolyzed Amino Acid Analysis Protein Chemistry extinction coefficient determination Show 7 more tags Show less

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Animal Isolators

Price on request

Isolators are critical for safeguarding your animals' health and genetic status, ensuring the welfare of your research models, and protecting the integrity of your research data. We offer semi-rigid and flexible isolators in three different sizes. We also can provide custom designs to meet individual client requirements. Upon... Show more »

Isolators are critical for safeguarding your animals' health and genetic status, ensuring the welfare of your research models, and protecting the integrity of your research data. We offer semi-rigid and flexible isolators in three different sizes. We also can provide custom designs to meet individual client requirements. Upon isolator purchase, we can schedule an on-site setup and training, as well as provide SOPs based on your need. Please find the following resource. IS:Semi Rigid and Flexible Film Isolators

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Abuse and Dependence Liability Testing

Price on request

Fully GLP-compliant abuse liability assays are offered in both rats and large animals in accordance with regulatory guidelines worldwide along with nonclinical screening in other standard models, addressing pain and specialized sensory functions, and various psychological and neurological disorders.

Fully GLP-compliant abuse liability assays are offered in both rats and large animals in accordance with regulatory guidelines worldwide along with nonclinical screening in other standard models, addressing pain and specialized sensory functions, and various psychological and neurological disorders.

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Abuse Liability abuse potential addiction addiction models behavioral assay behavioural assay conditioned place drug abuse drug addiction drug dependence dependence liability drug seeking discontunuation syndrome drug discrimination Show 14 more tags Show less

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In vivo Genotoxicity Testing

Price on request

Genetic toxicology studies are conducted to assess the potential for induction of genetic mutations or chromosomal damage and for more than 30 years, Charles River has been helping clients to develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs. Please find... Show more »

Genetic toxicology studies are conducted to assess the potential for induction of genetic mutations or chromosomal damage and for more than 30 years, Charles River has been helping clients to develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs. Please find the following resource. Safety: Genetic Toxicology

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In vitro Genotoxicity Testing

Price on request

Genetic toxicology studies are conducted to assess the potential for induction of genetic mutations or chromosomal damage and for more than 30 years, Charles River has been helping clients to develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs. Please find... Show more »

Genetic toxicology studies are conducted to assess the potential for induction of genetic mutations or chromosomal damage and for more than 30 years, Charles River has been helping clients to develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs. Please find the following resource. Safety: Genetic Toxicology

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Ototoxicity Testing

Price on request

The evaluation and assessment of potential ototoxicity of a compound involves a thorough safety evaluation that includes functional auditory testing, relevant histopathology and evaluation of the cytocochleogram. Please find the following resources. [Safety:Auditory Safety... Show more »

The evaluation and assessment of potential ototoxicity of a compound involves a thorough safety evaluation that includes functional auditory testing, relevant histopathology and evaluation of the cytocochleogram. Please find the following resources. Safety:Auditory Safety Inforgraphic and Safety: Auditory Safety Assessment

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MPI Research Mattawan Montreal ototoxicity auditory safety ototox cytochleogram auditory brainstem response drug-induced hearing loss drug-induced vestibular loss hearing loss hair cell ototoxicology auditory tox ear hearing Show 16 more tags Show less

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In vivo Phototoxicity Testing

Price on request

We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs to evaluate phototoxicity that meet standard and specialized requirements for evaluation of any test material. Utilizing a number of different light sources, including visible light, xenon arc solar simulators, and fluorescent... Show more »

We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs to evaluate phototoxicity that meet standard and specialized requirements for evaluation of any test material. Utilizing a number of different light sources, including visible light, xenon arc solar simulators, and fluorescent ultraviolet radiation sources, our scientists can design specialized exposure conditions and custom light source configurations for any product. Please find the following resource. Safety:phototoxicology

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In vitro Phototoxicity Testing

Price on request

We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs to evaluate phototoxicity that meet standard and specialized requirements for evaluation of any test material. Utilizing a number of different light sources, including visible light, xenon arc solar simulators, and fluorescent... Show more »

We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs to evaluate phototoxicity that meet standard and specialized requirements for evaluation of any test material. Utilizing a number of different light sources, including visible light, xenon arc solar simulators, and fluorescent ultraviolet radiation sources, our scientists can design specialized exposure conditions and custom light source configurations for any product. Please find the following resource. Safety:phototoxicology

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SEND Data Conversion

Price on request

Partnering with Charles River will ensure that you will have validated, submission-ready SEND packages that include all necessary accompanying materials (define.xml, nsdrg, and dataset validation reports) for your study. Clients can rely on our regulatory and data standards expertise to provide direction through the sometimes... Show more »

Partnering with Charles River will ensure that you will have validated, submission-ready SEND packages that include all necessary accompanying materials (define.xml, nsdrg, and dataset validation reports) for your study. Clients can rely on our regulatory and data standards expertise to provide direction through the sometimes confusing, and often changing, data standardization requirements. Please find the following resource. Safety:SEND

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Clinical Biomarkers

Price on request

We support our clients in the preclinical phase of their projects to identify potential biomarkers, and can support projects already entering the clinic to implement appropriate assays. Key to a successful program is the implementation of a validated set of analytical, cellular, and even functional assays, as part of the clinical... Show more »

We support our clients in the preclinical phase of their projects to identify potential biomarkers, and can support projects already entering the clinic to implement appropriate assays. Key to a successful program is the implementation of a validated set of analytical, cellular, and even functional assays, as part of the clinical team in Phase 0-2 studies, confirmation that the drug is engaging with the target and is having the effect predicted. Please find the following resource. Safety:Biomarker Assays

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KWS Biotest portishead clinical biomarkers PD biomarkers KWS biomarker testing pharmacodynamic biomarkers clinical sample analysis clinical services biomarker services Show 10 more tags Show less

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In vitro Immunogenicity Assays

Price on request

Immunogenicity refers to the ability of an antigen to induce an immune response. Proteins, peptides, monoclonal antibodies (mAbs), PEGylated proteins, multi-domain biotherapeutics, antibody-drug conjugates (ADCs) and cellular therapeutics are likely to be antigenic, which greatly affects the design of safety evaluation programs... Show more »

Immunogenicity refers to the ability of an antigen to induce an immune response. Proteins, peptides, monoclonal antibodies (mAbs), PEGylated proteins, multi-domain biotherapeutics, antibody-drug conjugates (ADCs) and cellular therapeutics are likely to be antigenic, which greatly affects the design of safety evaluation programs for biotechnology products. At Charles River, we have the expertise and resources to develop and validate methods, and perform sample analysis to help you fully study the immunogenicity of your novel compounds in discovery, preclinical and clinical stages. Immunogenicity of peptide and protein therapeutics and biosimilars is one of the primary concerns held by regulatory agencies worldwide. All therapeutic proteins and peptides can potentially trigger some level of immune response. Assays: - ADA screening - Confirmatory - Titration and isotyping - Neutralizing antibody (nAb) Platforms/Assay formats: - ELISA - Electrochemiluminescence (ECL) and Meso Scale Discovery (MSD) - Flow cytometry - SPEAD (solid-phase extraction with acid dissociation)

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Flow cytometry ELISA electrochemiluminescence ECL neutralizing antibody assays ADA Screening Confirmatory Titration and isotyping nAB Meso Scale Discovery MSD SPEAD solid-phase extraction with acid dissociation Show 13 more tags Show less

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Predictive Toxicology

Price on request

Charles River specialises in mapping human immune function ex vivo in early development and as part of clinical trials, and can work with you to predict unexpected immunotoxicology and reduce the risks involved. Please find the following resource. Safety:Predictive Immunotoxicology Services

Charles River specialises in mapping human immune function ex vivo in early development and as part of clinical trials, and can work with you to predict unexpected immunotoxicology and reduce the risks involved. Please find the following resource. Safety:Predictive Immunotoxicology Services

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Immunodeficient Animal Models

Price on request

Due to the challenges inherent in researching and developing anticancer therapeutics, it is important that you have the right tools and resources available to you. Furthermore, selecting the most appropriate animal model is a critical step when designing an oncology study. Please find the following resources. [RMS:North America... Show more »

Due to the challenges inherent in researching and developing anticancer therapeutics, it is important that you have the right tools and resources available to you. Furthermore, selecting the most appropriate animal model is a critical step when designing an oncology study. Please find the following resources. RMS:North America Immunodeficient Models and RMS:ncg mouse

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Immunodeficient Models nude rats immunodeficient mice nude mice SCID mice congenic mice Coisogenic mice oncology mice humanized mice microbiome mice Show 10 more tags Show less

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Scientific Consulting

Price on request

Charles River has built a team of talented scientific advisors whose sole purpose is to guide clients, every step of the way. With decades of industry experience and a proven ability to navigate a complex regulatory landscape, our Scientific Advisors design and manage lean yet robust nonclinical programs that reduce risk and... Show more »

Charles River has built a team of talented scientific advisors whose sole purpose is to guide clients, every step of the way. With decades of industry experience and a proven ability to navigate a complex regulatory landscape, our Scientific Advisors design and manage lean yet robust nonclinical programs that reduce risk and accelerate timelines. Their strategic advice includes customized program and study designs, risk mitigation tactics, program management, and regulatory advice. Please find the following resource. Safety: Scientific Advisory Services

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Analytical Ultracentrifugation (AUC)

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Biophysical Characterization AUC higher order structure HOS

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Intact Mass Analysis

Price on request

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized... Show more »

Charles River provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development.

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Mass Spec Mass Spectrometry MS

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Glycan Analysis

Price on request

Charles River offers an expert panel of services for the characterization of glycosylation. We specialize in comparability programs that may be used for manufacturing/process changes and for comparisons of originator vs. biosimilar products. Glycosylation Site Occupancy and Mapping via Peptide Mapping LC-MS/MS N-Linked... Show more »

Charles River offers an expert panel of services for the characterization of glycosylation. We specialize in comparability programs that may be used for manufacturing/process changes and for comparisons of originator vs. biosimilar products. Glycosylation Site Occupancy and Mapping via Peptide Mapping LC-MS/MS N-Linked Oligosaccharide Profile via LC-MS/MS O-Linked Oligosaccharide Profile via LC-MS/MS Quantitative Monosaccharide Analysis Quantitative Sialic Acid Determination Glycan Structural Characterization / Confirmation via MS Glycan Profile / Isoform via cIEF Exoglycosidase Glycan Sequence / Mapping

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GMP Glycosylation oligosaccharide profile glycosylation site occupancy monosaccharide analysis sialic acid determination Glycosylation Analysis Show 7 more tags Show less

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N-Terminal Sequencing

Price on request

To help clients generate the data needed to gain the level of product characterization required for regulatory submission, Charles River offers protein analysis as part of an integrated package of expert analytical services. We have extensive experience in developing and establishing protein characterization methods, including... Show more »

To help clients generate the data needed to gain the level of product characterization required for regulatory submission, Charles River offers protein analysis as part of an integrated package of expert analytical services. We have extensive experience in developing and establishing protein characterization methods, including product-specific in vitro potency assays. These characterization services are also a part of our stability and product release support services, where we offer key identity, purity and potency assays. Analytical Services: Mass spectrometry Biophysical characterization Glycosylation/Glycan characterization Chromatography & electrophoretic methods N-terminal sequencing and amino acid analysis ELISA and immunoassay development Potency assays

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Biophysical Characterization Protein Characterization Edman Degradation

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  • Positive review for Mycoplasma Testing:

    January 2018

    "Consistent, reliable mycoplasma testing service with rapid turnaround time."

Charles River has not received any endorsements.