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Charles River

ic 9.3/10 Overall Rating 90% Positive
ic 58 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 what... 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 (177)


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In vivo Drug Efficacy Testing

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Oncology Animal Models

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In vivo Pharmacology Studies

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In vivo Pharmacology Studies Services

In vivo Pharmacology Studies Services

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Flow Cytometry

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Animal Models and Studies

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In vitro Immunotoxicity Testing

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Mouse Rat Rodents Toxicology

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Biochemical Compound Screening

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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

Charles River provides a comprehensive range of biomarker services in key therapeutic areas. From early discovery stages to clinical support, the experienced scientists in the Biomarker Services group have the expertise to relate our biomarker service offerings to your drug development program, every step of the way.

Biomarker... Show more »

Charles River provides a comprehensive range of biomarker services in key therapeutic areas. From early discovery stages to clinical support, the experienced scientists in the Biomarker Services group have the expertise to relate our biomarker service offerings to your drug development program, every step of the way.

Biomarker assays and analytical readouts are important tools in drug discovery from target validation studies to candidate selection, so the ability to measure with accuracy and sensitivity is essential in making critical go/no-go study decisions. With years of experience in assay design and sample processing, Charles River can support your drug discovery pipeline by providing biomarker analysis in a non-GxP environment.
Whether your study is performed at your facility or designed and implemented at ours, our focus on strategic assay validation/qualification enables us to accurately test your study samples and provide reliable biological translation to your drug discovery program.

Charles River offers a wide range of study-specific analytical services using platforms such as Meso Scale Discovery (MSD®), Luminex®, ELISA, EIA, Western blotting and HPLC.

Services:
- Protein/phosphoprotein analysis
- Plate-based apoptosis assays
- Tumor profiling for target expression and modulation
- Tumor sampling for in vivo preclinical study to monitor for target modulation
- Cytokine analysis
- Clinical biochemistry testing
- Immunohistochemistry capabilities
- Mouse and rat gene expression testing
- Biobank resource of flash frozen samples of our in vivo portfolio available

On-Demand Assay Design and Development:
Our scientists will help to design and qualify study-specific biomarker assays and readouts for small and large research animal models. We can transfer and qualify assays, or develop them for you. Fast and accurate testing services are available once the assay is developed.

Therapeutic area-specific bioassays
Bioanalytical immunoassays
Infectious disease
Genetic biomarkers
Gene expression testing

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HPLC ELISA Enzyme immunoassay (EIA) Meso Scale Discovery (MSD®) Luminex®

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Immunobiology Services

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In vivo Toxicity Testing

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Alzheimer's Disease Animal Models

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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.

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Rodents CNS/Neurology Alzheimers Disease

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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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Cell-Based 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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Hit Identification Approaches Fragment screening Biology Drug Discovery

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CNS/Neurology Animal Models

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Drug Discovery & Development

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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

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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

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Veterinary Laboratory Services

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Assay Development

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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

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Cells and Tissues

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Chemical Synthesis

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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

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GEM Colony Care

Genetically Engineered Mouse Colony Care
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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.

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Histology and Pathology Services

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Histopathology
The Histology Group prepares over 1,000,000 tissues per year and is at the leading edge of new developments. The resultant slides from inhalation studies prepared by the Histology Group are evaluated by in-house pathologists who participate in peer reviews and pathology working groups, and several of whom... Show more »

Histopathology
The Histology Group prepares over 1,000,000 tissues per year and is at the leading edge of new developments. The resultant slides from inhalation studies prepared by the Histology Group are evaluated by in-house pathologists who participate in peer reviews and pathology working groups, and several of whom specialize in inhalation toxicology. Not only can digital microphotography be included in the contributing pathology report, but we are also able to share digitalized images of glass slides (for illustrative purposes) directly with the sponsor without them having to leave their office, through the use of the Aperio system.

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Immunohistochemistry (IHC)

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  • 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

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In vitro ADME Services

In vitro ADME Services

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In vitro Toxicity Testing

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In vitro Toxicity Testing Services

In vitro Toxicity Testing Services

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In vivo PK/PD Studies

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Process Consulting

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Project Management

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Surface Plasmon Resonance (SPR)

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Surface Plasmon Resonance

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

Surface Plasmon Resonance

  • Biacore 4000 for high-throughput hit identification
  • Biacore T200 with added sensitivity for kinetic profiling, mechanistic analysis and backup screening
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Biacore T-200 Biacore 4000 Biacore

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Toxicology

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Cell Line Generation

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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

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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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Hydrolyzed Amino Acid Analysis

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HPLC

High Performance Liquid Chromatography
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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

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Mass Spectrometry

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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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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.

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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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Chemistry and Materials

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Patch Clamp Recording

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Patient-Derived Xenograft (PDX)

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Animal Models of Disease

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Virology Testing

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In vitro Disease Models

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In vitro Disease Models Services

In vitro Disease Models Services

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Pharmaceutical Formulation

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Energy Dispersive Spectroscopy

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Cell Lines

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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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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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Biomarkers

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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

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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 Mental Health CNS/Neurology Neurodegenerative diseases

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Computational Drug Discovery

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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

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Pain Drug Discovery Services

At Charles River, we have developed validated models for in vitro and in vivo studies along with a comprehensive toolkit, including imaging, translational behavior and fine motor kinematics to accelerate novel therapies to treat acute and chronic pain. We offer comprehensive ion channel panels... Show more »

Pain Drug Discovery Services

At Charles River, we have developed validated models for in vitro and in vivo studies along with a comprehensive toolkit, including imaging, translational behavior and fine motor kinematics to accelerate novel therapies to treat acute and chronic pain. We offer comprehensive ion channel panels focused on pain as well as multiple in vivo readouts, including tactile and thermal hyperalgestia, cold allodynia, nocifensive behavior, fine motor kinematics, dynamic weight bearing and kinetic PET imaging.
We offer a growing portfolio of various pain models targeting chronic joint pain, inflammatory pain, nociception and neuropathic pain. Additionally, our scientists conduct contract studies in trigeminal ganglia electrostimulation and cortical spreading depression (KCl-induced) animal models to assess the efficacy of novel antimigraine drugs.
We also proof-of-principle/proof-of-concept studies for neuroprotection and reduction of infarct, as well as longer-term, more comprehensive studies looking at functional and cognitive outcomes or stroke prevention. Animal models of stroke and brain ischemia available for use in our studies include the tMCAO, MCAO, EMCAO as well as brain ischemia and hind limb peripheral ischemia models.

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Xenograft Models

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Animal Microdialysis

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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.

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CNS/Neurology

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DART Studies

Developmental and Reproductive Toxicology Studies
Price on request

Charles River offers overall developmental and reproductive toxicology (DART) program planning and individual study design to conduct safety assessments for your products according to internationally recognized guidelines, including ICH and OECD.

We conduct male and female fertility, developmental toxicity (embryo-fetal... Show more »

Charles River offers overall developmental and reproductive toxicology (DART) program planning and individual study design to conduct safety assessments for your products according to internationally recognized guidelines, including ICH and OECD.

We conduct male and female fertility, developmental toxicity (embryo-fetal development), pre- and postnatal development and multigenerational studies to assess the potential effects of novel products on the entire reproductive spectrum. Our expertise includes pharmaceuticals (including vaccines, biopharmaceuticals, and veterinary and medical devices) agrochemicals, industrial chemicals and food additives. Our multigenerational study portfolio now includes the Extended One-Generation Reproductive Toxicity Study, required to satisfy OECD Guideline 443.

A full range of rodent and nonrodent species are tested with dose routes ranging from dermal to intravenous infusion. A range of specialized functional evaluations is also available, including neurobehavioral testing and immunologic assays. All studies are supported by our own laboratory and regulatory experts.

  • Developmental and reproductive pathology
  • Specialized neurobehavioral testing
  • Functional assessments, including growth (and the skeleton), pulmonary, neurobehavioral, reproductive and immunological development
  • Toxicokinetic evaluations, including induction studies
  • Juvenile toxicity testing in rodents and nonrodent species
  • Screening Information Data Sets (SIDS)

Specialized evaluations:
- Hormone assays
- Male reproductive assessments in rodents and nonrodents
- Variety of behavioral tests (e.g., activity and learning and memory) for pre- and postnatal and multigenerational studies
- Range of developmental immunology tests that can be added to pre- and postnatal and multigenerational studies
- Endocrine disruptor screenings (in vivo and in vitro)
- Skeletal measurements (e.g., bone size, geometry and density) for pre- and postnatal studies using micro-CT, pQCT, X-ray and DXA

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Rabbit Sheep Goat Mouse Pig Rat Cow Minipig Show 8 more tags Show less

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Drug Development Consulting

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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

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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

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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

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Electrophysiology Services

Electrophysiology Services

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Bioanalytical Assays

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Protein Crystallization Screening and Optimization

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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.

  • 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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Protein Production

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Ligand Binding Assays

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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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Cell and Tissue Culture

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Material Testing Services

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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

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PK/PD PK 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

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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.

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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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Hit to Lead and Lead Optimization

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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... Show more »

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

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.
We will work closely with you to define the compound profile required, prioritizing compounds for detailed evaluation and interpreting results from a customized screening cascade including primary target and cellular activity together with ADME/PK assessment and target engagement biomarker assay development. Our medicinal chemists have an impressive track record of delivering high-quality lead series to our clients within agreed timelines across a broad range of target classes and therapeutic areas.

Hit-to-Lead Activities:

  • Design and synthesis of new analogues for rapid SAR determination
  • Increasing compound potency and selectivity
  • Improvement of drug-like properties
  • Applying CADD to generate binding hypotheses and to investigate SAR
  • Early assessment of ADME properties
  • Evaluation of target engagement biomarker assays
  • Ranking of hits or hit series for lead optimization

Lead optimization is a core strength within Charles River. We are able to consistently deliver high-quality, preclinical development candidates (63 since 2001) within industry standard timelines, including the data required to support progression into investigational new drug (IND) studies. A significant percentage of the 63 candidates identified have progressed to clinical proof-of-concept, illustrating their high quality. In addition, the first drug on the market resulting from a collaboration with Charles River's medicinal chemistry group was announced in July 2014.
Our efficiency is achieved through the integration of key disciplines, such as assay development and screening, computer-aided drug design, ADME/PK and pharmaceutical sciences, into project teams with many years of experience in tackling the problems associated with converting leads into candidates. An additional aid to efficient decision making during this phase of a project is the use of translational biomarkers, which are employed whenever possible.

We also have many years of experience in providing medicinal chemistry services in joint project teams with a variety of pharmaceutical and biotechnology companies.
This collaborative approach to our partners' drug discovery programs is reflected in patent applications (where our scientists appear as joint inventors on client projects) and in our publications. Wherever possible, we encourage our scientists to publish, present and defend posters, and present orally at conferences.

Lead Optimization Deliverables

  • Compounds with maximized potency and selectivity plus minimized toxicity
  • Compounds with evidence of target or pathway engagement in human systems
  • Human dose predictions
  • Patent filings
  • Generation of a preclinical candidate meeting agreed criteria
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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

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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

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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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Our ocular specialists perform safety and efficacy studies using intravitreal injection, topical instillation, subretinal dosing and other systemic routes of exposure. Programs are designed for therapeutic agents targeting a range of diseases and conditions, such as age-related macular degeneration, diabetic retinopathy, glaucoma... Show more »

Our ocular specialists perform safety and efficacy studies using intravitreal injection, topical instillation, subretinal dosing and other systemic routes of exposure. Programs are designed for therapeutic agents targeting a range of diseases and conditions, such as age-related macular degeneration, diabetic retinopathy, glaucoma and cytomegalovirus. In addition, we can perform in vitro eye irritation testing and can confirm negative tests in vivo.

Support Services:
- Specular microscopy for noninvasive, in vivo evaluation of the corneal endothelium
- Electroretinography
- Spectral domain optical coherence tomography (SD-OCT, anterior and posterior)
- Tonometry (IOP) evaluations
- Pachymetry (corneal thickness)
- Digital fundus photography/video
- Confocal scanning laser ophthalmoscope (multiple image modes - infrared and tomography for 3D images)
- Fundus autofluorescence
- Fluorescein angiography (FA) and Indocyanine green angiography (ICG)
- Vitrectomy
- Quantitative autoradiography
- Ocular and systemic tissue distribution
- Enhanced microscopic evaluation
- Ocular surgery/implant

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Rabbit Mouse Rat Minipig

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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.

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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

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Compound Profiling

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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... 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.

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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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Orthotopic Tumor Animal Models

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X-Ray Powder Diffraction

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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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Controlled Release Systems

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Animal Blood Collection

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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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In vitro Genotoxicity Testing

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Dose Range Finding (DRF) Studies

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In vitro Immunogenicity Assays

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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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Drug Discovery

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PCR

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In vitro Percutaneous Absorption Studies

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Animal Plasma and Serum

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In Vitro Skin Corrosion Test

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 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 Surgery

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

Charles River is AALAC certified.

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

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

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Bioanalysis

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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.

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.

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Hamster Mouse Rat GMP Antibody Production Tumorigenicity inapparent virus general safety Vaccines Show 9 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

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Endotoxin Testing

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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

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Radiochemistry

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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
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Environmental Impact Assessment

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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

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Integrated Drug Discovery

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Charles River’s integrated drug discovery programs have reduced the drug discovery timeline to as little as 24 months through industry experienced, multi-disciplinary teams focused on resource efficiency, scientific excellence and strategic partnerships. With numerous technologies for hit identification and knowledge-based... Show more »

Charles River’s integrated drug discovery programs have reduced the drug discovery timeline to as little as 24 months through industry experienced, multi-disciplinary teams focused on resource efficiency, scientific excellence and strategic partnerships. With numerous technologies for hit identification and knowledge-based approach to lead optimization along with the development of targeted in vitro and in vivo assays, our integrated research teams consistently convert leads into successful preclinical development candidates.

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CNS/Neurology

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Regulatory Affairs Consulting

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Ex vivo Electrophysiology

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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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Biomolecular Interaction Analysis

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Ion Channel Screening Assays

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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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Biopharmaceutical Manufacturing

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Safety Pharmacology

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Making decisions about your safety pharmacology study can be challenging. We can help. Charles River has established ICH core battery tests and supplementary models to meet current regulatory requirements and provide meaningful data. We can customize your study to address both your program- and compound-specific needs, or include... Show more »

Making decisions about your safety pharmacology study can be challenging. We can help. Charles River has established ICH core battery tests and supplementary models to meet current regulatory requirements and provide meaningful data. We can customize your study to address both your program- and compound-specific needs, or include our core safety parameters in toxicology studies as an efficient means of meeting regulatory expectations.

Our safety pharmacology facilities feature dedicated telemetry suites, surgical pharmacology capabilities and custom-built cardiovascular laboratories that allow for remote observation of the animals without disrupting data collection.

We have validated the use of electrocardiogram (ECG) pattern recognition software to increase the sensitivity of our ECG analyses, and have integrated automated arrhythmia detection for full ECG data sets.

The core battery of safety pharmacology studies should be included in small molecule IND-enabling programs to assess the acute and potentially life-threatening risks of novel pharmaceuticals for human use.

  • Cardiovascular System: Blood pressure, heart rate, electrocardiograms (ECGs), left ventricular pressure, echocardiography
  • Respiratory System: Respiratory rate, hemoglobin oxygen saturation, tidal and minute volumes
  • Central Nervous System (CNS): Functional observation battery (FOB), modified Irwin screen, body temperature, large animal neurological evaluations
  • In Vitro Electrophysiology: Cloned human potassium channels (hERG)

Second-tier studies can be used to develop a greater understanding of mechanistic effects on vital functions, and evaluate potential adverse effects on other organ systems such as renal and gastrointestinal systems.

  • Tier II Assessments: Cardiovascular system, central nervous system (CNS) and respiratory system assessments
  • Renal/Urinary: Renal function and general clinical chemistry
  • Gastrointestinal: Motility and function
  • In Vitro Electrophysiology: Anticipated CiPA battery
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Liver Fibrosis Animal Models

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Functional Human Tissue Assays

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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

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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

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Microbiology Testing

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Transgenic Mouse Services

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IND-Enabling Studies

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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.

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.

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IND-Enabling Studies IND Submission Investigative New drugs

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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

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High Throughput Screening (HTS)

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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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CAR-T Cell Therapy Cell Therapy Cell and Gene Therapy

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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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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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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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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

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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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Cytotoxicity Assays

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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

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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

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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

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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

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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

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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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Animal Isolators

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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.

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Genetically Engineered Mice

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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.

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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

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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.

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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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  • Positive review for Mycoplasma Testing:

    January 2018

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

Charles River has not received any endorsements.