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Charles River

ic 9.0/10 Overall Rating 84% Positive
ic 40 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 (394)


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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.

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Purity Assay Copy Number GMP Mycoplasma Detection 16S rDNA sequencing Sterility Cell Line Identification adventitious agent testing 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 Microbial Contamination Virological Contamination Genetic Stability Show 21 more tags Show less

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Hepatic Animal Models

Price on request
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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.

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GMP Bacteria Yeast Stem Cells Insect Cells mammalian cells microbial cells Show 7 more tags Show less

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In vitro Cardiotoxicity Screening

Price on request

Charles River offers preclinical cardiac risk assessment services together with industry-leading expertise. Offerings range from GLP hERG and action potential duration (ADP) assays, which are recommended for candidate selection and IND submissions, to a comprehensive survey of cardiac ion channels and cardiomyocyte assays. Our... Show more »

Charles River offers preclinical cardiac risk assessment services together with industry-leading expertise. Offerings range from GLP hERG and action potential duration (ADP) assays, which are recommended for candidate selection and IND submissions, to a comprehensive survey of cardiac ion channels and cardiomyocyte assays. Our services provide insight into potential cardiac risk and aid in effective decision-making in early preclinical development.

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Compound Profiling

Price on request

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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Genetic Stability Testing

Price on request

The identity and integrity of recombinant genes has to be verified and shown to be stable throughout the production process. Stability is supported by characterization studies for mammalian or microbial cells at the end of production and comparing the attributes to those of the master cell bank.
Charles River applies the... Show more »

The identity and integrity of recombinant genes has to be verified and shown to be stable throughout the production process. Stability is supported by characterization studies for mammalian or microbial cells at the end of production and comparing the attributes to those of the master cell bank.
Charles River applies the following methods to determine the genetic stability of recombinant products and to characterize plasmid products:
Restriction endonuclease analysis
Copy number determination
DNA/RNA/plasmid sequencing
Retention of recombinant construct
Retention of selectable marker
Determination of yeast prototrophy

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Cell Uptake/Transporter Assays

Price on request

Epithelial Ion Transport Assays: Ussing Chamber Assay (UCA) for screening CFTR and ENaC ion channels

Epithelial Assay Benefits:
Identify activators or inhibitors channels essential for epithelial ion conductance
Determine concentration-response relationships for CFTR modulators or inhibitors
Evaluate effects on ENaC – an... Show more »

Epithelial Ion Transport Assays: Ussing Chamber Assay (UCA) for screening CFTR and ENaC ion channels

Epithelial Assay Benefits:
Identify activators or inhibitors channels essential for epithelial ion conductance
Determine concentration-response relationships for CFTR modulators or inhibitors
Evaluate effects on ENaC – an important target in hypertension and cystic fibrosis

Ussing Chamber Assays Available:
Screen against the ΔF508-CFTR (associated with Cystic Fibrosis) in CF patient-derived bronchial epithelial (CFhBE) primary cultures
Screen against wild-type CFTR in NhBE cells from normal patients
Epithelial Sodium Channel assay (ENaC) in NhBE.

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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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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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Disinfectant Testing

Price on request

Charles River's disinfectant efficacy testing is performed in accordance with USP chapters <1072> and <1227>, AOAC 955.14 and 964.02, EN13704, EN13697, EN1276, EN1650 and EN13704, each study is designed to evaluate a disinfectant at the concentration(s) commonly used against a panel of clinically significant microorganisms and... Show more »

Charles River's disinfectant efficacy testing is performed in accordance with USP chapters <1072> and <1227>, AOAC 955.14 and 964.02, EN13704, EN13697, EN1276, EN1650 and EN13704, each study is designed to evaluate a disinfectant at the concentration(s) commonly used against a panel of clinically significant microorganisms and environmental isolates (up to BSL Level 2) on the surfaces routinely disinfected.

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Disinfectant Efficacy Determination

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Stable Cell Line Generation

Price on request

Charles River has extensive experience in generating stable cell lines for high-throughput screening and compound profiling. We offer a customized service, starting with stable expression of single proteins through to stable co-expression of multiple protein subunits.

You can also access a range of validated assays, in addition... Show more »

Charles River has extensive experience in generating stable cell lines for high-throughput screening and compound profiling. We offer a customized service, starting with stable expression of single proteins through to stable co-expression of multiple protein subunits.

You can also access a range of validated assays, in addition to our assay development and validation service, with expression profile selected to suit specific assay formats.

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Antibody-Drug Conjugate 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,... 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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Lead Identification and Validation

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Animal Antiserum Production

Price on request

Charles River offers monoclonal and polyclonal antisera production in a variety of species, such as rodents and farm animals (sheep and goats are the most commonly used). Projects can be customized to meet client requirements and GMP standards. Other product types available include de brinated blood products, whole blood in... Show more »

Charles River offers monoclonal and polyclonal antisera production in a variety of species, such as rodents and farm animals (sheep and goats are the most commonly used). Projects can be customized to meet client requirements and GMP standards. Other product types available include de brinated blood products, whole blood in anticoagulant (sodium citrate, Alsever’s, heparin), serum, plasma and lysed blood.

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Rabbit Goat Chicken GMP Antibody Production

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Radiochemistry

Price on request
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In vitro Immunotoxicity Testing

Price on request
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Mouse Rat Rodents Toxicology

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Cardiovascular Animal Models

Price on request
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Biopharmaceutical Development

Price on request

With decades of success in building biologics, Charles River is likewise an ideal partner in the development of biosimilars. We deliver client-focused solutions for the speci c 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 speci c 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 ef ciencies 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., ow cytometry and other biomarkers as appropriate).

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GMP Biosimilarity analysis Hormones mAbs Cytokines

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Vaccines

Price on request

As part of the Charles River vaccine program, we draw from our global scientific network to provide vaccine companies with considerable exibility 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 exibility 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 Tumorigenicity Immunotoxicology formulation development safety assessment efficacy testing immunology challenge studies virus manufacturing dose response biodistribution virology Microbiology Show 20 more tags Show less

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Research Record Retention

Price on request

Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of... Show more »

Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of preclinical and clinical studies for government and private sector businesses, organizations and consortia.
By archiving with Charles River you get:
- Expedited retrieval of records for agency/client inspections
- Site visits and on-site access to Study Directors
- Full service record keeping from inception to destruction

Facilities and Services:
- Over 500,000 cubic feet of controlled, dedicated space
- Several layers of security to limit access as well as safeguard essential study materials under GLP conditions
- Storage conditions include room temperature, refrigerated, frozen at -20°C or -70°C and cryostorage at -196°C
- Periodic inventory and materials inspections
- Hard copy transfer to CD
- Microform printing
- Pick-up and delivery services for both short-term and long-term storage

Materials:
- Paper data, records and reports
- Electronic media
- Microform

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Chloride Channel Assays

Price on request
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Cell-Based Screening Methods

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Vaccine Testing Services

Price on request

Experience with in vivo bacterial and vaccine challenge studies has become an important element of drug discovery and development. Designing an animal challenge study that will translate to humans requires consideration of route of infection, infectious dose, permissive animal species, vaccine formulation, biomarkers, immune... Show more »

Experience with in vivo bacterial and vaccine challenge studies has become an important element of drug discovery and development. Designing an animal challenge study that will translate to humans requires consideration of route of infection, infectious dose, permissive animal species, vaccine formulation, biomarkers, immune responses and disease endpoints. Charles River conducts in vivo challenge studies with BSL-2 pathogens. Observing our commitment to humane care,
we address all regulations, animal ethics and safety considerations when working with pathogens. Scientists from our Microbiology, Discovery, Biologics and Safety Assessment groups assist sponsors in these nonclinical and regulatory aspects of vaccine development.

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Influenza Respiratory syncytial virus (RSV) Potency Assay GLP GMP Reproductive Toxicology Immunogenicity Studies in vivo Tumorigenicity Immunotoxicology safety assessment efficacy testing dose response biodistribution virology Microbiology Show 16 more tags Show less

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Calcium Channel Assays

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Neuropathology

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Charles River combines experienced pathologists with a highly trained technical staff and well-designed laboratories to offer pathology services in the specialized area of neuropathology. We provide assistance in study design, development strategies and regulatory submissions for a wide variety of compounds affecting the nervous... Show more »

Charles River combines experienced pathologists with a highly trained technical staff and well-designed laboratories to offer pathology services in the specialized area of neuropathology. We provide assistance in study design, development strategies and regulatory submissions for a wide variety of compounds affecting the nervous system. Each year, our scientists conduct over 30 GLP-compliant neuropathology studies in support of FDA and EPA regulatory submissions.

  • Whole-body perfusion
  • Specialized nerve tissue embedding
  • Specialized staining capabilities
  • Electron microscopy (transmission electron microscopy and scanning electron microscopy)
  • Morphometric analysis
  • Immunohistochemistry
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Potassium Channel Assays

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Electron Microscopy

Price on request

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

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

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

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

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Humanized Mouse Models

Price on request

Charles River offers two study platforms using humanized mouse models (NOG, NSG, and the new NCG) engrafted with CD34+ or PBMC. Our models have been characterized with known immune checkpoint inhibitors of clinical relevance to help take the next step in evaluating your compound in immuno-oncology. We have validated our... Show more »

Charles River offers two study platforms using humanized mouse models (NOG, NSG, and the new NCG) engrafted with CD34+ or PBMC. Our models have been characterized with known immune checkpoint inhibitors of clinical relevance to help take the next step in evaluating your compound in immuno-oncology. We have validated our patient-derived xenograft models as well as our human xenograft portfolio and provide the widest platform for testing your therapeutic in a humanized system.

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BD FacsCantoII/LSRII IVIS Attune NXT IVIS Spectrum CT Bruker In Vivo MS FX Pro Mouse Humanized mouse Immunology Oncology Immuno-Oncology Cancer Melanoma Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukemia (ALL) Chronic Myelogenous Leukemia (CML) Chronic Lymphocytic Leukemia (CLL) Hodgkin's Lymphoma Non-Hodgkin Lymphoma Colorectal cancer Prostate Cancer Breast cancer Lung Cancer Ovarian Cancer Gastric Cancer Flow cytometry Immunoassays Cell culture Biomarker discovery Immune Profiling Biomarker analysis FACS Immunogenicity Studies Flow in vitro in vivo Human tumor Tumor cells Cell Line tumor Biology Drug Discovery Genomics Toxicology biomarker Drug-Gene Regulation kinase antibody Oncotest PDX Collection Show 48 more tags Show less

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Scientific Sourcing

Price on request

The Charles River RightSource℠ scientific staffing program is a flexible insourcing/outsourcing option for biologics developers and manufacturers. The RightSource℠ 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... Show more »

The Charles River RightSource℠ scientific staffing program is a flexible insourcing/outsourcing option for biologics developers and manufacturers. The RightSource℠ 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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Cell Services

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Stereology

Price on request

We offer a full range of services for discovery and GLP-compliant studies from conception and design through to data analysis. We are ready to help you with a wide range of measurements, including cell counts, cell or tissue volumes, and length and surface area determination for all tissue sizes from any species.

We offer a full range of services for discovery and GLP-compliant studies from conception and design through to data analysis. We are ready to help you with a wide range of measurements, including cell counts, cell or tissue volumes, and length and surface area determination for all tissue sizes from any species.

  • Analysis directly on scanned slides using Visiopharm®, GLP-validated software
  • Plastic and frozen sectioning capability
  • Systematic uniform random sampling and analysis of tissues of any size from all species
  • Counting objects using physical or optical dissectors
  • Estimation of volume for tissues, tissue compartments, or cells
  • Estimation of surface area and length
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Drug Discovery Toxicology

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Ex vivo Electrophysiology

Price on request

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

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

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Syngeneic (Allograft) Tumor Models

Price on request

Charles River offers a broad range of syngeneic tumor models with well-characterized responses to known immune checkpoint inhibitors (e.g., anti-PDL-1, anti-PD-1 and anti-CTLA-4), making us the ideal partner to advance your immuno-oncology pipeline.

Now available! Use whole exome sequencing (WES) data to enhance your model... Show more »

Charles River offers a broad range of syngeneic tumor models with well-characterized responses to known immune checkpoint inhibitors (e.g., anti-PDL-1, anti-PD-1 and anti-CTLA-4), making us the ideal partner to advance your immuno-oncology pipeline.

Now available! Use whole exome sequencing (WES) data to enhance your model selection, giving you the ability to choose based on mutation status as well as sensitivity to immune checkpoint inhibitors. To view WES data, visit our Tumor Model Compendium.

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BD FacsCantoII/LSRII IVIS Attune NXT IVIS Spectrum CT Bruker In Vivo MS FX Pro Mouse Rat Immunology Oncology Immuno-Oncology Cancer Melanoma Acute Lymphocytic Leukemia (ALL) Chronic Lymphocytic Leukemia (CLL) Hodgkin's Lymphoma Non-Hodgkin Lymphoma Colorectal cancer Prostate Cancer Breast cancer Lung Cancer Ovarian Cancer Gastric Cancer Flow cytometry Cell culture Biomarker analysis FACS Cell line engineering Flow in vitro in vivo Tumor cells Cell Line tumor Biology Drug Discovery Genomics Toxicology Syngeneic Models Show 38 more tags Show less

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Hypertension Animal Models

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Image Analysis

Price on request

Our state-of-the-art facilities house image analysis systems that perform all of the standard and user-defined static and dynamic measurements for bone. The dynamic measurements can be completed with or without fluorochrome labels.
Our facilities also provide a wide range of image analysis techniques for other tissues.... Show more »

Our state-of-the-art facilities house image analysis systems that perform all of the standard and user-defined static and dynamic measurements for bone. The dynamic measurements can be completed with or without fluorochrome labels.
Our facilities also provide a wide range of image analysis techniques for other tissues. Whole-slide scanning with online slide viewing capabilities is available, as are whole-slide morphometric analysis and stereological analysis on slides scanned using GLP-validated Visiopharm® software.
Each system is operated by highly trained technical staff supervised by pathologists board certified by the American College of Veterinary Pathologists, Royal College of Pathologists and European College of Veterinary Clinical Pathology.

  • Small intestine villus length, crypt depth and villus/crypt ratios
  • Image analysis of immunohistochemically or histochemically stained slides, including number of labeled cells, area of positive staining and tissue composition analysis
  • Determination of cell proliferation index (Ki67, BrdU, PCNA) or apoptotic index (caspase-3, TUNEL)
  • Diameter of stented blood vessels
  • Extent of infarcts in the heart
  • Capillary angiogenesis in cutaneous wound defects, including microvascular density quantification
  • Goblet cell number in the respiratory tract
  • Adult and juvenile rat cerebellar and cerebral measurements
  • Axon and nerve fiber changes in peripheral nerves
  • Skeletal muscle characterization
  • Pulmonary fibrosis assessment
  • Thyroid gland epithelial height and colloid area for endocrine disruptor assessment
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Cell Electrophysiology

Price on request

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

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

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Coronary Artery Disease Animal Models

Price on request
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Protein Production

Price on request
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In situ Hybridization (ISH)

In Situ Hybridization
Price on request
  • RNAscope® technology
  • Fluorescein probe
  • Chromogenic probe
  • Biotin probe
  • Digoxigenin probe
  • 33P-labeled probes
  • Autoradiographic emulsion detection
  • Microautoradiography detection
  • RNAscope® technology
  • Fluorescein probe
  • Chromogenic probe
  • Biotin probe
  • Digoxigenin probe
  • 33P-labeled probes
  • Autoradiographic emulsion detection
  • Microautoradiography detection
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Patch Clamp Recording

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Cardiomyocyte Toxicity Assay

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Immunohistochemistry (IHC)

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

Price on request

Origin
This immunodeficient nude mouse originated from NIH and was originally thought to be a BALB/c congenic. It was later determined that it was not inbred and is therefore maintained as an outbred. It is not associated with any stock or strain. The animal lacks a thymus, is unable to produce T cells, and is therefore... Show more »

Origin
This immunodeficient nude mouse originated from NIH and was originally thought to be a BALB/c congenic. It was later determined that it was not inbred and is therefore maintained as an outbred. It is not associated with any stock or strain. The animal lacks a thymus, is unable to produce T cells, and is therefore immunodeficient. To Charles River from NCI in 2010.

Coat Color
Hairless, albino background

Ideal For:
Tumor biology and xenograft research

Strain Code:
491 (Heterozygous, not immunodeficient), 490 (Homozygous)

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Arrhythmia Animal Models

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Tissue Cross Reactivity Studies

Price on request

Charles River can support your monoclonal antibody research with our expertise in the initial stages of safety assessment for therapeutic antibodies targeted for use in humans. We hold a full range of tissues from various animal species, including human.
For immunohistochemistry-based tissue cross-reactivity studies, we provide... Show more »

Charles River can support your monoclonal antibody research with our expertise in the initial stages of safety assessment for therapeutic antibodies targeted for use in humans. We hold a full range of tissues from various animal species, including human.
For immunohistochemistry-based tissue cross-reactivity studies, we provide efficiency of scale in full compliance with Good Laboratory Practice (GLP) regulations and interpretation of findings, and can represent you in presenting to the applicable regulatory agencies.

Tissue-Based Biomarkers:
We provide correlative studies that are designed as an adjunct to clinical trials. These studies assist in determining whether a drug is reaching the intended target and whether the drug will work the same way in humans as it has in animals. Because each project has its own unique requirements, our pathologists and scientists will work closely with you to identify which tissue-based biomarkers to assess.

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In vivo PK/PD Studies

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Central Lab Services

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Action Potential Duration Assay

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Anatomic Pathology

Price on request

With full-service pathology and histology laboratories and facilities strategically positioned across the United States, Canada and Europe, we have both the infrastructure and the scientific expertise to readily meet the evolving needs of our clients. We offer services ranging from traveling necropsy teams to routine toxicity... Show more »

With full-service pathology and histology laboratories and facilities strategically positioned across the United States, Canada and Europe, we have both the infrastructure and the scientific expertise to readily meet the evolving needs of our clients. We offer services ranging from traveling necropsy teams to routine toxicity histopathological assessments. Our global pathology network has unparalleled capacity, allowing us to perform the histologic processing and histopathologic evaluation of several million tissue samples every year.

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Electroencephalogram (EEG) Models

Price on request

At Charles River, we use EEG monitoring to assess changes in sleep state and electrical activity associated with neurological disease models of seizure. Using a telemetric approach, EEG patterns indicative of changes in underlying neuronal function are recorded and show specific rhythmic activity that can be used as... Show more »

At Charles River, we use EEG monitoring to assess changes in sleep state and electrical activity associated with neurological disease models of seizure. Using a telemetric approach, EEG patterns indicative of changes in underlying neuronal function are recorded and show specific rhythmic activity that can be used as characteristic translational biomarkers. Understanding the effects of test compounds on the activity and function of the brain are essential in drug development and Charles River can perform continuous EEG following acute or chronic compound treatment in combination with PK/PD studies and behavioral testing.

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CNS/Neurology

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Engineering and Fabrication

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Ecotoxicity Testing

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Ecotoxicity Testing Services

Ecotoxicity Testing Services

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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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Human Tumor Xenograft Models

Price on request

Our broad range of tumor lines ensures a wide variety of testing alternatives for your agent. Our xenograft model portfolio is evaluated on a regular basis for response to standards of care and this data is available for designing combination studies.

Our scientific staff can assist in selecting the most appropriate model for... Show more »

Our broad range of tumor lines ensures a wide variety of testing alternatives for your agent. Our xenograft model portfolio is evaluated on a regular basis for response to standards of care and this data is available for designing combination studies.

Our scientific staff can assist in selecting the most appropriate model for your agent. Complete profiling of agents can be carried out in a variety of tumor types or in combination with the appropriate clinical agent.

  • Human Tumor Xenografts (mice)
  • Human Tumor Xenografts (rats)
  • Patient-Derived Xenografts (PDX)
  • Syngeneic Models
  • Orthotopic Models
  • Angiogenesis Model
  • Cachexia Model
  • Radiation
  • Neurotoxicity
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Drug Target Identification

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Veterinary Pathology

Price on request

Charles River offers a complete range of clinical pathology laboratory services to support animal models, discovery and/or preclinical studies. Our clinical pathology laboratory staff has extensive knowledge of animal and human hematology, coagulation, clinical biochemistry and urinalysis. In addition, specialized pathology... Show more »

Charles River offers a complete range of clinical pathology laboratory services to support animal models, discovery and/or preclinical studies. Our clinical pathology laboratory staff has extensive knowledge of animal and human hematology, coagulation, clinical biochemistry and urinalysis. In addition, specialized pathology laboratory services are available to meet your assay or biomarker development needs for specific research requirements or drug safety studies.
Our staff, which includes pathologists certified by the American College of Veterinary Pathologists and the European College of Veterinary Clinical Pathology, has expertise across the spectrum of major therapeutic areas and routinely assesses and interprets data from regulatory and investigative/research studies. With nine state-of-the-art clinical pathology labs, we can support all stages of human and veterinary drug development. We conduct research in accordance with the current standards of Good Laboratory Practice (GLP).

Capabilities - Standard Platforms:
- Hematology and coagulation
- Clinical biochemistry (including microsampling)
- Urinalysis
- Bone marrow and bronchoalveolar evaluation
- Blood gas
- Platelet function

Capabilities - Specialized Platforms
- Cytology (CSF, BAL, etc.)
- Hormones
- Cytokines
- Hemolytic studies
- Assay/Method development and validation

Scientific Expertise:
- Broad experience in regulatory assessment and interpretation of clinical pathology data from regulatory and investigative/research studies
- Clinical pathology report preparation
- Scientific cross-linking and integrated reports
- Bridging of clinical medicine, laboratory medicine and basic sciences
- Contribution to study design, special investigations, health authorities’ questions and regulatory documents (e.g., expert reports, IBs, CTDs)

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Animal Microdialysis

Price on request

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

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

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CNS/Neurology

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Biomarker Discovery

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In vitro Angiogenesis Assays

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hERG Channel Inhibition Assay

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Animal Movement Analysis

Price on request

Fine Motor Kinematic Analysis - Scientists at Charles River use a novel automated and high-precision system coupled with proprietary data analysis methods to successfully analyze fine motor skills in mouse models of neurological diseases. Fine motor kinematic analysis reveals early changes in muscular or neuronal function in... Show more »

Fine Motor Kinematic Analysis - Scientists at Charles River use a novel automated and high-precision system coupled with proprietary data analysis methods to successfully analyze fine motor skills in mouse models of neurological diseases. Fine motor kinematic analysis reveals early changes in muscular or neuronal function in disease models to support the development of therapeutics that reverse or slow progressive degeneration and to test compounds that can cause fine motor impairment as a side effect.
The experimental output is a high speed film that is analyzed using proprietary algorithms to generate quantitative analysis of over 100 movement associated parameters.

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Mouse CNS/Neurology

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Animal Microsensor Studies

Price on request

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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IND-Enabling Studies

Price on request

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

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Orthotopic Tumor Animal Models

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Electrophysiology Animal Models

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In 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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CNS/Neurology electrophysiology single cells

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Animal Blood Collection

Price on request

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

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

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In vivo 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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Minipig

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In vivo ADME/DMPK Studies

Price on request

In vivo ADME/DMPK Studies Services

In vivo ADME/DMPK Studies Services

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Cachexia Animal Models

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Custom Cell-Based Assay Development

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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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Environmental Impact Assessment

Price on request

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

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

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Bioanalytical Analysis LC/MS/MS

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Cognition and Behavior Animal Models

Price on request

Sub-chronic Phencyclidine

Sub-chronic Phencyclidine

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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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Cell Culture Consulting

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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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Endocrine Disruptor Screening

Price on request

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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Hybrid LBA/LC-MS Assays

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Assay Development

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Huntington's Disease Animal Models

Price on request

Quinolinic Acid Huntington's Model

Quinolinic Acid Huntington's Model

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2D Cell Culture

Price on request

In addition to more than 200 commercial human tumor cell lines, we currently have 80 proprietary cell lines derived from our PDX models, each with selected clinical data and comprehensive molecular data for the originating tumor, and which have been characterized by their sensitivity for up to 240 reference agents.

By using... Show more »

In addition to more than 200 commercial human tumor cell lines, we currently have 80 proprietary cell lines derived from our PDX models, each with selected clinical data and comprehensive molecular data for the originating tumor, and which have been characterized by their sensitivity for up to 240 reference agents.

By using cell lines derived from our portfolio of PDX models, we retain characteristics such as expression and mutation profiles, which enables us to offer “matched pairs” of xenografts and corresponding cell lines. This allows you to use the same models for in vitro, ex vivo and in vivo efficacy studies.

We offer fixed screening panels for the most cost- and time-efficient studies such as:

  • Solid tumor histotypes
  • Hematological cell lines
  • Asian cancer cell lines
  • We also offer customized panels of up to 100 cell types.
  • Our 2D assays can be used in a variety of ways:
  • Assessment of potency and selectivity
  • Identification of mode of action via COMPARE analysis
  • Administration of combination studies
  • Analysis of multidrug resistance
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Assay Development Consulting

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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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Immunocytochemistry

Price on request

ICC is particularly suitable to answer questions related to the localization of signal transduction markers. ICC is routinely performed on brain sections that can best be prepared by means of frozen sectioning. The availability of primary antibodies or radioligands directed against neurotransmitters, cell surface receptors and... Show more »

ICC is particularly suitable to answer questions related to the localization of signal transduction markers. ICC is routinely performed on brain sections that can best be prepared by means of frozen sectioning. The availability of primary antibodies or radioligands directed against neurotransmitters, cell surface receptors and intracellular receptors, intracellular proteins, peptides etc. these days is nearly unlimited. We have experience with these techniques, with particular interest in receptor systems, G-proteins, kinases and phophatases, neuropeptides, neurotransmitters and neurotransmitter-specific enzymes, cytoskeletal proteins; to mention only a few groups of biomarkers that are being studied.

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In vitro Neurotoxicity Testing

Price on request

The neurotoxicology program at Charles River encompasses a broad range of products, including pharmaceuticals, biopharmaceuticals, chemicals and agrochemicals, in both rodent and nonrodent species. With over two decades of experience, we have a valuable historical control database for tests in developmental neurotoxicology. We... Show more »

The neurotoxicology program at Charles River encompasses a broad range of products, including pharmaceuticals, biopharmaceuticals, chemicals and agrochemicals, in both rodent and nonrodent species. With over two decades of experience, we have a valuable historical control database for tests in developmental neurotoxicology. We also have a knowledgeable staff of scientists and technical personnel who routinely perform neurotoxicity screening tests for possible on- or off-target effects, specialized target tissue delivery, expanded investigative studies and developmental neurotoxicity.

Capabilities include:
- Neurobehavior, including assays of locomotor activity, rotarod forced activity, water maze learning and memory testing, auditory startle habituation and functional observational batteries
- Neurochemistry, including cholinesterase assays in red blood cell, plasma and brain samples, as well as quantification of endogenous levels of neurotransmitters
- Neuropathology, including in situ perfusion, morphometry, stereology and qualitative neuropathological evaluations
- Drug abuse/dependence liability testing

Dose Routes:
- Standard dose routes
- Routine and specialized routes of parenteral injection or infusion and target-tissue administration
- Intravenous
- Subcutaneous
- Epidural
- Intrathecal
- Intracerebroventricular
- Intracerebral
- Intracisternal

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Analytical Method Development

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Animal Quarantine Service

Price on request

Charles River's isolator-based quarantine facilities allow us to accept animals from any institution worldwide, regardless of their health status. Breeding, mating and procedures can be arranged to help speed the expansion of your colony or keep your study on track during the quarantine period.

Quarantine Services:

PRIA... Show more »

Charles River's isolator-based quarantine facilities allow us to accept animals from any institution worldwide, regardless of their health status. Breeding, mating and procedures can be arranged to help speed the expansion of your colony or keep your study on track during the quarantine period.

Quarantine Services:

PRIA (PCR Rodent Infectious Agent Panel) Quarantine: Up to 10 mice quarantined following our standard PRIA health testing protocol (6 weeks) $2,385

Standard Quarantine: Up to 10 mice or 5 rats quarantined following our standard health testing protocol (10 weeks) $3,155

Standard Quarantine with Breeding: Up to 17 cages of mice or 8 cages of rats following our standard health testing protocol (10 weeks) $3,880

Note: Charles River will develop customized health testing protocols to meet individual facility requirements. We can also accommodate large-scale breeding projects during quarantine. Please contact us for pricing on these custom options.

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Cancer Cell Line Panels

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Biochemical Assay Kits

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Parkinsons Disease Animal Models

Price on request

Classical rodent models for Parkinson’s disease, such as 6-OHDA or MPTP lesioning, are standard working tools that offer mechanistic support for therapeutic testing. Charles River has maximized the utility of these models by providing a comprehensive and translatable modeling platform of chemically and biologically induced (6-OHDA... Show more »

Classical rodent models for Parkinson’s disease, such as 6-OHDA or MPTP lesioning, are standard working tools that offer mechanistic support for therapeutic testing. Charles River has maximized the utility of these models by providing a comprehensive and translatable modeling platform of chemically and biologically induced (6-OHDA and MPTP) and genetic models (A53T Alpha-Synuclein mouse model and AAV-human A53T transgenic rat model). Translational tools to assess Parkinson’s disease progression and symptoms include fine motor kinematics to assess gait changes, MRI and nuclear imaging and the assessment of biomarkers via immunohistochemistry, ELISA etc.

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Mouse Rat CNS/Neurology Parkinson's disease (PD)

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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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Manufacturing Services

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In vitro Genetic Screening

Price on request

Charles River offers screening assays to support our clients during their hit-to-lead and lead optimization phases of drug discovery. These assays are highly predictive of the regulatory assays and can be used to support go/no-go decisions. Because of low compound requirement, screening assays are the ideal tool at stages where... Show more »

Charles River offers screening assays to support our clients during their hit-to-lead and lead optimization phases of drug discovery. These assays are highly predictive of the regulatory assays and can be used to support go/no-go decisions. Because of low compound requirement, screening assays are the ideal tool at stages where compound synthesis is not yet optimized or more data is needed before committing resources to further compound development.

In Vitro Assays:
- Bacterial Mutation Test (OECD 471)
- Ames MPF, Ames II, mini Ames
- Mammalian Cell Gene Mutation Test (HPRT Gene, OECD 476)
- Mammalian Chromosome Aberration Test (OECD 473)
- Mammalian Cell Gene Mutation Test (TK Gene, OECD 490)
- Mammalian Cell Micronucleus Assay (OECD 487)
- Fluorescence In Situ Hybridization (FISH)

In Vivo Assays:
- Mammalian Alkaline Comet Assay (OECD 489)
- Rodent Micronucleus Test (OECD 474)
- Unscheduled DNA Synethesis (OECD 486)
- Bone Marrow Chromosome Aberration (OECD 475)
- Pig-a Gene Mutation Assay
- Immunofluorescent Antikinetochore (CREST Staining)
- Combined Comet/Micronucleus Assay

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Analytical Chemistry Services

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Transgenic Mouse Services

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Bone Safety Studies

Price on request

Charles River offers a fully integrated service with a team of scientists, pathologists, veterinarians and surgeons in the field of musculoskeletal research. Our team of musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal... Show more »

Charles River offers a fully integrated service with a team of scientists, pathologists, veterinarians and surgeons in the field of musculoskeletal research. Our team of musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system.
This integrated approach allows the comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications.

Models include:
- Gonadectomy (ovariectomy and orchiectomy)-induced bone loss for osteoporosis drug testing
- 5/6 nephrectomy model
- TPTx (thyroparathyroidectomy) model
- Schenk model in weanling rats (screen for anti-resorptive agents)
- Bone defect models
- Orthopedic models
- Osteoarthritis models
- Rheumatoid arthritis models

Non-GLP efficacy models are also available for your early research.

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications. Non-GLP efficacy models are available for early research.

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Mouse Rat

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Bioanalytical Assays

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Genetically Engineered Mice

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Animal Embryo and Sperm Cryopreservation

Starting at $3,640.00 per strain

Mouse embryo cryopreservation for heterozygous animals crossed with a wildtype strain.

Guaranteed delivery of 250-300 cryopreserved embryos.

We recommend that you plan to send 4-6 males (< 6 months old), and 20 females (3-4 weeks old). Fewer than 4 males will be accepted, however the timeline of the project may be... Show more »

Mouse embryo cryopreservation for heterozygous animals crossed with a wildtype strain.

Guaranteed delivery of 250-300 cryopreserved embryos.

We recommend that you plan to send 4-6 males (< 6 months old), and 20 females (3-4 weeks old). Fewer than 4 males will be accepted, however the timeline of the project may be extended.

Note on additional services available (not included in price):
Charles River can provide wildtype females if you prefer not to ship them . We can also store your cryopreserved strains for you. We offer secure cryostorage in two independent facilities. Please speak to one of our client services representatives about this additional service.

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Alzheimer's Disease Animal Models

Price on request

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

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

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Rodents CNS/Neurology Alzheimers Disease

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Product Quality Control

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Rodent Rederivation

Starting at $2,575.00 per strain

Rapid rederivation by embryo transfer (mouse) - $2,575.00 USD per Strain

  • Requirements: 2 males (<6 months old); 10 females (3-4 weeks old)
  • Deliverables: Minimum of 2 visibly pregnant, embryo transfer females
  • Estimated Project Timeline: 6 weeks
    _______

Rederivation by embryo transfer with health report -... Show more »

Rapid rederivation by embryo transfer (mouse) - $2,575.00 USD per Strain

  • Requirements: 2 males (<6 months old); 10 females (3-4 weeks old)
  • Deliverables: Minimum of 2 visibly pregnant, embryo transfer females
  • Estimated Project Timeline: 6 weeks
    _______

Rederivation by embryo transfer with health report - $5,560.00 USD per Strain

  • Requirements: 2 males (<6 months old); 10 females (3-4 weeks old)
  • Deliverables: Minimum 10 offspring with complete health report (conventional colony will be maintained until project completion)
  • Estimated Project Timeline: 12-15 weeks
    _______

Rederivation by embryo transfer with homozygous expansion breeding (mouse) - $7,420.00 USD per Strain

  • Requirements: 5 breeding pairs (minimum)
  • Deliverables: Minimum 10 offspring with complete health report (conventional colony will be maintained until project completion)
  • Estimated Project Timeline: 6-9 months
    _______

Note:

All rederived animals from Charles River meet our VAF/Elite® health status, backed by our track record of 100% success in removing unwanted organisms in over 10,000 unique mouse and rat strains.

Customize a rederivation program to meet your project needs and timelines: embryo or sperm rederivation, standard or rapid turn-around time.

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Hairless Rat Model

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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 Enzyme immunoassay (EIA) Meso Scale Discovery (MSD®) Luminex® ELISA Western blotting Show 6 more tags Show less

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CNS/Neurology Animal Models

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PK/PD Data Analysis

Price on request

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

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

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WinNonlin®

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Spectroscopy

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Ligand Binding Assays

Price on request

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

Peptides, monoclonal antibodies (mAb), multi-domain antibodies, antibody-drug conjugates (ADC), biosimilars, and traditional and next-generation oligonucleotides—Charles River scientists are global leaders in this rapidly growing and evolving field. 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 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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Mass Spectrometry Ligand binding assays (ELISA and MSD Automated ELISA Ligand binding with LC-MS detection (Hybrid hybrid assays) Radioimmunoassay (RIA) Enzyme immunoassay (EIA) Fluorescence immunoassay (FIA) Immunoradiometric assay (IRMA) Dissociation-enhanced lanthanide fluorescence immunoassay (DELFIA) Scintillation proximity assay (SPA) Luminex® Show 11 more tags Show less

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In vitro Ion Channel Assays

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Pharmaceutical Formulation

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Liquid Chromatography (LC)

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Discovery Pathology

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Adding anatomic and clinical pathology endpoints in discovery studies enhances the understanding, characterization and translational ability of animal models, as well as allows for comparison of developmental candidates and lead optimization and provides, in some cases, early efficacy information.

Charles River combines... Show more »

Adding anatomic and clinical pathology endpoints in discovery studies enhances the understanding, characterization and translational ability of animal models, as well as allows for comparison of developmental candidates and lead optimization and provides, in some cases, early efficacy information.

Charles River combines expertise from our discovery, research models and preclinical services groups with our pathology expertise to provide clients with a comprehensive approach to animal model evaluation for specialized therapeutic areas, including oncology, cardiovascular, respiratory, CNS, ophthalmology, inflammation and metabolic disease.

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Industrial Design

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Western Blot

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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 electroforeses and transferal to a membrane antibodies can be used to detect and qunatify a protein/receptor of interest.

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Transgenic Breeding and Genotyping

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Carcinogenicity/Tumorigenicity Testing

Price on request

Our carcinogenicity toxicology studies in rodents and toxicity studies in both rodent and nonrodent species (including the minipig) are performed in full compliance with Good Laboratory Practice (GLP) regulations. In addition, all protocols are designed to meet the regulatory requirements of the various countries in which the products are to enter clinical trials or be marketed.

Our carcinogenicity toxicology studies in rodents and toxicity studies in both rodent and nonrodent species (including the minipig) are performed in full compliance with Good Laboratory Practice (GLP) regulations. In addition, all protocols are designed to meet the regulatory requirements of the various countries in which the products are to enter clinical trials or be marketed.

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Rabbit Mouse Rat Minipig

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GEM Colony Care

Genetically Engineered Mouse Colony Care
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Drug Development

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Mammalian Models

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Transgenic Animal Colony Management

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Business Development Consulting

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Drug Discovery Consulting

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Drug Discovery

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Bioanalytical Assay Development and Optimization

Price on request

Synthetic Chemistry
To assist in quantitative bioanalysis, our chemical synthesis group can produce non-labeled or stable isotype-labeled compounds, such as deuterated or carbon-13 analogues, for use as internal standards. We can also assist with metabolite identification, profiling and synthesis.

Method Development and... Show more »

Synthetic Chemistry
To assist in quantitative bioanalysis, our chemical synthesis group can produce non-labeled or stable isotype-labeled compounds, such as deuterated or carbon-13 analogues, for use as internal standards. We can also assist with metabolite identification, profiling and synthesis.

Method Development and Transfer
Dedicated method development teams are able to rapidly evaluate and develop assays for you. Our firsthand knowledge in the development of a wide range of compounds and our experience across the drug development continuum can be used to help you create an efficient, cost-effective and successful program from discovery through the clinical phase. Our experts provide services for method transfer, development and validation in accordance with Good Laboratory Practices (GLP).

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Cells and Tissues

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Animal Imaging

Price on request

Imaging has the potential to dramatically increase the efficiency of lead candidate selection by providing earlier and more highly predictive data, compared with traditional methods. Imaging is also well suited for facilitating translation between preclinical testing and clinical evaluation of drugs. Furthermore, imaging methods... Show more »

Imaging has the potential to dramatically increase the efficiency of lead candidate selection by providing earlier and more highly predictive data, compared with traditional methods. Imaging is also well suited for facilitating translation between preclinical testing and clinical evaluation of drugs. Furthermore, imaging methods are more easily applied than traditional methods in the newer, more realistic models of human disease that are becoming increasingly prevalent.

Charles River has an in vivo imaging facility with high-field MRI, PET/CT and SPECT/CT scanners for radionuclide-based imaging applications. All platforms are applicable for longitudinal studies with multiple imaging endpoints to study phenotype progression and treatment efficacy, biodistribution or tissue activity changes.

  • Anatomical MRI
  • Diffusion MRI
  • fMRI & phMRI
  • Hemodynamic MRI
  • Localized 1H-MRS
  • Optical Coherence Tomography
  • Positron Emission Tomography (PET)
  • Single Photon Emission Computed Tomography (SPECT)
  • Radiochemistry
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CNS/Neurology Neurodegenerative diseases

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Multiomics

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In vitro Phototoxicity Testing

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Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the... Show more »

Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs that meet not only standard, but specialized requirements for evaluation of any test material.

Cytotoxicity endpoints in cell lines or hepatocytes
- In vitro 3T3 NRU phototoxicity assay (OECD 432; ICH S10)
- In vitro phototoxicity in the human reconstructed skin model Epiderm (ICH S10)
- Photo Ames assay
- Melanin Binding assay (ICH S10)
- In vitro drug screening, development and safety testing
- Regulatory experience in the phototoxicology field

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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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Formulation Services

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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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Cytotoxicity Assays

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Antibody Services

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Infusion Toxicology

Price on request

Charles River has decades of experience in the conduct of safety and efficacy studies utilizing infusion dosing techniques essential for evaluating parenteral drug formulations. Our in-depth knowledge and skill of intermittent and continuous infusion studies for both rodent and nonrodent species can help support your research.... Show more »

Charles River has decades of experience in the conduct of safety and efficacy studies utilizing infusion dosing techniques essential for evaluating parenteral drug formulations. Our in-depth knowledge and skill of intermittent and continuous infusion studies for both rodent and nonrodent species can help support your research. Acute to chronic studies requiring infusions of minutes or hours to continuous (24-hour) infusion using indwelling or peripheral catheters can be performed, as appropriate.

To overcome the ever-increasing challenges posed by pharmaceutical and biopharmaceutical compounds, we are continually expanding our range of infusion toxicology services to meet the needs of this specialized route of administration. Procedures have been established to allow us to support the conduct of ICH-compliant reproductive and juvenile toxicology studies utilizing infusion techniques.

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Rabbit Mouse Rat Minipig

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Rodent Breeding

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Mouse Rat Rodents

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Biochemical Compound Screening

Price on request

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

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

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

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

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

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

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Biology Drug Discovery

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Geological Sciences

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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 High-throughput screening Medicinal chemistry knowledge-based design Fragment screening Biology Drug Discovery Show 6 more tags Show less

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Material Testing Services

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Flow Cytometry

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Clinical Sample Kits

Price on request

Biological samples are key components of clinical studies that provide important information on the toxicity, pharmacokinetics and/or efficacy of a new drug. They also often provide critical data on the new drug’s market potential.
To support your clinical program, we offer customized clinical sample kits. We have over 40 years... Show more »

Biological samples are key components of clinical studies that provide important information on the toxicity, pharmacokinetics and/or efficacy of a new drug. They also often provide critical data on the new drug’s market potential.
To support your clinical program, we offer customized clinical sample kits. We have over 40 years of experience in sample management and kit assembly for Phase I to III clinical trials worldwide. Our kits are specifically designed to facilitate the collection, shipment and storage of your samples.

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Mouse Models

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Sequencing data in FASTQ

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CAR-T Cell Therapy Development

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Transporter & Cell Uptake Assays

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Animal Facility Environmental Monitoring

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Environmental monitoring provides a proactive approach to identifying and excluding harmful factors that may affect the health of your animal colonies. Our professional staff members will work with to you develop a customized program for your facility utilizing microbiological or PCR testing methods.

Environmental monitoring provides a proactive approach to identifying and excluding harmful factors that may affect the health of your animal colonies. Our professional staff members will work with to you develop a customized program for your facility utilizing microbiological or PCR testing methods.

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Dermal Toxicity Studies

Price on request

Our full dermal toxicology testing service is designed to cross all industrial sectors. Therapeutic indication and topical use are considered in the design of a dermal testing program. We offer a range of studies to include penetration, irritation, sensitization, wound healing and photobiology. In addition, access to advanced... Show more »

Our full dermal toxicology testing service is designed to cross all industrial sectors. Therapeutic indication and topical use are considered in the design of a dermal testing program. We offer a range of studies to include penetration, irritation, sensitization, wound healing and photobiology. In addition, access to advanced technology allows us to offer in vitro alternatives to traditional in vivo models for some forms of testing.

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Rabbit Mouse Rat Minipig

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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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Clinical Sample Services

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Brown Norway Rat Model

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Origin
Silvers and Billingham began brother x sister matings with selection for histocompatibility in 1958 from a brown mutation in a stock of wild rats maintained by King and Aptekman in a pen-bred colony of rats trapped from the wild in 1930 by King at the Wistar Institute. To Charles River from Radiobiology Institute,... Show more »

Origin
Silvers and Billingham began brother x sister matings with selection for histocompatibility in 1958 from a brown mutation in a stock of wild rats maintained by King and Aptekman in a pen-bred colony of rats trapped from the wild in 1930 by King at the Wistar Institute. To Charles River from Radiobiology Institute, Netherlands in 1976.

Coat Color
Non-agouti brown

MHC Haplotype
RT1n

Ideal For:
Respiratory inflammation, genetic mapping, immunological dysfunction, aging, transplantation research

Strain Code:
091

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Rat

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Animal Learning, Memory, and Behavior Tests

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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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Animal Models and Studies

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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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Biocompatibility Testing

Price on request

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the... Show more »

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications. Non-GLP efficacy models are available for early research.

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Clinical Laboratory Services

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Immune Function Testing

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At Charles River, our immunology groups can evaluate a compound’s potential to be an immunosuppressor or an immunostimulator. We can provide you with fully integrated services to support toxicology and clinical studies that determine the safety of compounds, and define immunological endpoints and alterations of cellular function... Show more »

At Charles River, our immunology groups can evaluate a compound’s potential to be an immunosuppressor or an immunostimulator. We can provide you with fully integrated services to support toxicology and clinical studies that determine the safety of compounds, and define immunological endpoints and alterations of cellular function induced by test compounds.

Assays:
- T-Cell dependent antibody response – TDAR (ELISA or Plaque)
- Immunophenotyping in blood or organs (flow cytometry)

Neutrophil/Macrophage (flow cytometry)
- Oxidative burst activity
- Phagocytosis
- Migration

Complement (ELISA, flow cytometry)

Cytokine/Chemokine (ELISA, flow cytometry)
- Profiling
- Release

  • Proliferation (beta counter, flow cytometry)
  • Natural killer (NK) cell activity (gamma counter, flow cytometry)
  • Basophil (flow cytometry)
  • T-cell cytotoxicity
  • ADCC/CDC (flow cytometry)
  • ELISpot and FluoroSpot
  • Extracellular markers of cell activation, indicators of cell injury and death, and receptor occupancy and test article binding (flow cytometry)
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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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Computational Drug Discovery

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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... 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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Cryopreservation

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Orthopedic Models

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Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the... Show more »

Our musculoskeletal specialists can assess the safety and efficacy of drugs and devices that have an intentional or unintentional effect on the musculoskeletal system. This includes comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility, orthopedic device efficacy and the effects of new orthobiologic applications. Non-GLP efficacy models are available for early research.

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Editorial and Writing Services

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Custom Biochemical Assay Development

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Charles River develops and executes more than 100 assays per year covering an extensive range of target classes. We have broad expertise in developing biochemical and cellular assays for:

  • Ion channels
  • Epigenetic protein targets
  • Kinases
  • G-protein coupled receptors (GPCRs)
  • Protein-protein interactions

Beyond the... Show more »

Charles River develops and executes more than 100 assays per year covering an extensive range of target classes. We have broad expertise in developing biochemical and cellular assays for:

  • Ion channels
  • Epigenetic protein targets
  • Kinases
  • G-protein coupled receptors (GPCRs)
  • Protein-protein interactions

Beyond the target family expertise, our scientists regularly develop assays for novel modes of actions to address pharmacological relevance.

Clients can access our assay development service or elect to transfer their own validated assays to us. We have developed disease-relevant assays in human primary cells for inflammatory diseases, bone and joint diseases, respiratory diseases, neurodegenerative diseases, obesity and diabetes, as well as oncology.

Key Technology Platforms

  • 96, 384 and 1536 densities
  • Capillary-based and automated pipetting instrumentation
  • Radioisotopic assays
  • Electrophysiology, including automated patch-clamp and conventional techniques
  • Multi-modal fluorescence and luminescence readouts
  • High-content, multi-parametric analysis
  • High-throughput plate imaging
  • Multi-array electrochemiluminescence detection
  • Label-free screening
  • Surface plasmon resonance
  • "Lab on a chip" microfluidic assays
  • Screening under Biosafety Level 2 containment
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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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Clinical and Anatomic Pathology

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Services provided include clinical chemistry, hematology, coagulation assays and urinalysis performed by experienced technical, scientific and biomedical staff. For inhalation studies, bronchoalveolar lavage analysis can be performed with cell count and other evaluations.

Services provided include clinical chemistry, hematology, coagulation assays and urinalysis performed by experienced technical, scientific and biomedical staff. For inhalation studies, bronchoalveolar lavage analysis can be performed with cell count and other evaluations.

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Immunoassays

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Protein Structure Determination

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Crystal Bank

Charles River has experience with many targets of pharmaceutical interest covering a range of gene families, including kinases (Ser/Thr and Tyr), phosphodiesterases, nuclear hormone receptors, and proteases such as deubiquitinases and other epigenetic targets.
Crystal Bank is a library of >75 proteins with known... Show more »

Crystal Bank

Charles River has experience with many targets of pharmaceutical interest covering a range of gene families, including kinases (Ser/Thr and Tyr), phosphodiesterases, nuclear hormone receptors, and proteases such as deubiquitinases and other epigenetic targets.
Crystal Bank is a library of >75 proteins with known routes to structure, which can be used to speed up the analysis of your protein/ligand complexes by X-ray crystallography.

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Animal Models of Disease

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Medical Device Testing

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Antimicrobial Activity Testing

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Immunostaining

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Immunology Animal Models

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With over 25 years’ experience, the Immunology Group offers a range of services, including assessment of immunotoxicity, immunomodulation, immune biomarkers, immunogenicity, and molecular biology assays. Depending on the pharmacology and toxicology of the compound to be tested, it is possible that inhalation studies may have one... Show more »

With over 25 years’ experience, the Immunology Group offers a range of services, including assessment of immunotoxicity, immunomodulation, immune biomarkers, immunogenicity, and molecular biology assays. Depending on the pharmacology and toxicology of the compound to be tested, it is possible that inhalation studies may have one or more of these assessments and assays included.

The Immunology Group provides guidance and assays as per ICHS8 to support immunotoxicology evaluation of compounds. In addition, the Immunology Group has conducted numerous assays to assess immunomodulation, such as measurement of immune biomarkers including cytokines, chemokines, complement factors and immunoglobulins. The Immunology Group also supports other immunogenicity testing needs, including screening, confirmatory assays, titration and neutralizing antibody assays.

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Salt Screening

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Salt Screening
With a wide range of pharmaceutically acceptable salts available, the correct choice of salt form and method of production can be vital. Charles River can perform multiple salt screens to improve an API or IMP’s solid form characteristics, such as solubility/dissolution, stability (both chemical and polymorphic)... Show more »

Salt Screening
With a wide range of pharmaceutically acceptable salts available, the correct choice of salt form and method of production can be vital. Charles River can perform multiple salt screens to improve an API or IMP’s solid form characteristics, such as solubility/dissolution, stability (both chemical and polymorphic) and hygroscopicity. Salts are characterized using a variety of techniques and their solubility assessed, thus providing early directional data for the selection of the optimum salt. We take an adaptive approach to help you meet your goals in the shortest possible timelines.

With the ability to scale up salts in jacketed vessels from 250mL to 20L, Charles River can provide sufficient material for all pre-GMP work if required and liaise with third parties to ensure the correct solid form is produced. Appropriate documentation is provided to facilitate GLP services.

Characterization of Salts
Determination of optimum conditions for production of salt using metastable zone width properties
Thermodynamic solubility measured in a range of aqueous buffers
Dissolution rates assessed in a variety of biologically relevant media
Long-term stability trials under ICH guidelines
Forced degradation studies including light and solution stability assessment
In-house micronization and particle size determination to meet specified requirements

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Clinical Immunology Tests

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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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Physical Analysis Methods

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A full knowledge and understanding of the properties of a compound is essential in drug discovery. At Charles River, we can measure a wide variety of molecular properties in both the solid and the solution state to facilitate rapid development.

Physical Properties

  • LogP, pKa, logD
  • Melting points and other thermal events... Show more »

A full knowledge and understanding of the properties of a compound is essential in drug discovery. At Charles River, we can measure a wide variety of molecular properties in both the solid and the solution state to facilitate rapid development.

Physical Properties

  • LogP, pKa, logD
  • Melting points and other thermal events using DSC
  • Degradation using TGA and TGA-IR
  • Hygroscopicity using DVS
  • Particle size
  • Particle morphology using SEM
  • Toughness and hardness
  • Lactose blend performance using NGI technology
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Animal Model in vivo Analyses

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Polymorphism Screening

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Polymorphism Screening
The importance of understanding and controlling the crystalline form produced cannot be overstated. The production of the incorrect polymorphic form can have an effect on a variety of parameters which will have an impact on the quality of your API.
Charles River has the ability to perform multiple... Show more »

Polymorphism Screening
The importance of understanding and controlling the crystalline form produced cannot be overstated. The production of the incorrect polymorphic form can have an effect on a variety of parameters which will have an impact on the quality of your API.
Charles River has the ability to perform multiple crystallization screens to investigate solid-state polymorphism. Using a variety of techniques, we aim to identify and characterize all relevant polymorphic forms as well as any hydrates or solvates of your API. Ultimately, our goal is to identify and recommend the most thermodynamically stable form under ambient conditions and provide you with information on how to obtain it.

Polymorphism Characterization
XRPD to obtain a fingerprint diffractogram
TGA and DSC to understand thermal behavior
Microscopy to assess crystal habit (optical or SEM as appropriate)
Hot-stage microscopy to correlate with events observed in TGA and DSC
GVS to assess hygroscopicity
UPLC™ and 1H NMR to assess chemical purity, structural integrity and residual solvent levels
Storage under ICH guidelines to assess stability
Thermodynamic solubility and kinetic dissolution rates in any relevant media
Single-crystal X-ray diffraction (on special request)

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DART Studies

Developmental and Reproductive Toxicology Studies
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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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High Content Screening

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High-Content Platform

Our high-content screening (HCS) platforms offer high-throughput screening and high-content profiling using standard cell models, human primary cells or disease-related cell lines. We develop assays for small molecule screening using our 850,000 compound collection and for RNAi screening using our... Show more »

High-Content Platform

Our high-content screening (HCS) platforms offer high-throughput screening and high-content profiling using standard cell models, human primary cells or disease-related cell lines. We develop assays for small molecule screening using our 850,000 compound collection and for RNAi screening using our proprietary adenoviral platform, SilenceSelect®.

The infrastructure available in-house at Charles River includes multiple GE InCell Analyzer 2200 instruments, GE InCellAnalyzer 6000, TTP LabTech Acumen Explorer™, BD Pathway™ 435, LI-COR Odyssey imager and 10 TB and 30 TB dedicated image servers.

Our extensive experience in high-throughput screening, in-house image analysis algorithm design and disease biology allows us to make the right selection of cell type and assay parameters before initiating HCS. Our expertise in assay development, image analysis and screening includes:

  • Anchorage independence (in 3D)
  • Apoptosis and cell death
  • Autophagy and protein aggregation
  • Cell motility and migration
  • Cytoskeletal rearrangements
  • Epigenetic modifications
  • Live imaging (e.g., Ca flux)
  • Marker expression
  • Neurite outgrowth
  • Protein acetylation and phosphorylation
  • Receptor internalization and degradation
  • Sub-cellular localization
  • Translocation of transcription factors
  • Viral replication
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Drug Discovery

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Blending

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Powder formulation can be prepared on site for use on GLP toxicology studies. Micronized test article can be blended with an appropriate excipient, using a validated, custom-designed, high-efficiency blending system. The uniformity of the resultant blend and its achieved concentration is determined. Results are then processed,... Show more »

Powder formulation can be prepared on site for use on GLP toxicology studies. Micronized test article can be blended with an appropriate excipient, using a validated, custom-designed, high-efficiency blending system. The uniformity of the resultant blend and its achieved concentration is determined. Results are then processed, verified, audited by our Quality Assurance unit, and a certificate of use prepared, allowing the blend to be released for use on the study.

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Fragment Screening

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Charles River has extensive capabilities in fragment-based drug discovery (FBDD), offering access to expertise in screening, structural biology, and computational and medicinal chemistry. Our range of fragment libraries and orthogonal fragment screening technologies allows us to customize a fragment-based lead discovery solution... Show more »

Charles River has extensive capabilities in fragment-based drug discovery (FBDD), offering access to expertise in screening, structural biology, and computational and medicinal chemistry. Our range of fragment libraries and orthogonal fragment screening technologies allows us to customize a fragment-based lead discovery solution to a wide array of target types.

Our FBDD platform provides access to:

  • Orthogonal Screening Technologies - Technologies include thermal shift assay, surface plasmon resonance (SPR) using Biacore™ instrumentation, isothermal titration calorimetry (ITC), NMR, high-concentration biochemical assay and X-ray crystallography
  • Structural Biology - Experience in the development of structure routes to support FBDD; in-house X-ray facility and Crystal Bank of structures
    Unique
  • Fragment Library - 1,500 member core library, 500 member kinase focused set and 500 member 19F labelled set, all designed for fragment screening and rapid FBDD optimization of hits
  • Computational Chemistry - Proprietary fragment hit expansion techniques and fragment shape-based analysis tools
  • Medicinal Chemistry - Expertise in structure-based drug discovery and fragment hit optimization
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Animal Model Housing and Maintenance

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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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Cell Lines

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Liver Steatosis Animal Models

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Mouse Non-Alcoholic Steatohepatitis (NASH)

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Energy Dispersive Spectroscopy

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Data Services

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In vivo Acute Toxicity Studies

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Rat

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X-Ray Powder Diffraction

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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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Project Management

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Transgenic Animal Model Development

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Virology Testing

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Inhalation Toxicology

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With decades of experience, Charles River offers a full range of inhalation toxicology study designs to support the worldwide registration of pharmaceuticals, agrochemicals and chemicals. Our expert toxicologists work within our modern inhalation laboratory facilities, which are equipped with custom-designed apparatus for a... Show more »

With decades of experience, Charles River offers a full range of inhalation toxicology study designs to support the worldwide registration of pharmaceuticals, agrochemicals and chemicals. Our expert toxicologists work within our modern inhalation laboratory facilities, which are equipped with custom-designed apparatus for a variety of inhalation toxicology studies in multiple species.

Our experience includes specialized studies to demonstrate efficacy or pharmacotoxicity, the selection of inhaled drug formulations and inhalation delivery systems, design of appropriate analytical methodologies and the estimation of dosage in animal models.

Study Types
- Reproductive inhalation
- Immunologic sensitization via inhalation
- Intranasal
- Intratracheal
- Anti-asthmatic efficacy
- Neonatal inhalation
- Acute to chronic toxicity, plus carcinogenicity
- Nose-only, oronasal and head-only
- Radiolabeled aerosol studies

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Viral Assays

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Pharmacology & Toxicology

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Transdermal/Transmucosal Drug Delivery Systems

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Patient-Derived Xenograft (PDX)

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Angiogenesis & Endothelial Cell Assays

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Gene Therapy Development

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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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Controlled Release Systems

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Protein Quantification

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Protein Expression Visualization

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Cytometry

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Preclinical Study Design

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Stem Cell Lines

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Animal Biospecimens

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Feasibility Studies

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Statistical Analysis

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Toxicology Risk Assessment

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For more than 30 years, Charles River has been helping clients develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs as part of a comprehensive safety assessment program or as a stand-alone service.
With three sites in North America and Europe and a team of... Show more »

For more than 30 years, Charles River has been helping clients develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs as part of a comprehensive safety assessment program or as a stand-alone service.
With three sites in North America and Europe and a team of more than 70 scientists and support staff, we take an active role in the development of the assays and have in-depth experience complying with global regulatory guidelines and guidance (FDA, EPA, OECD, ICH, EMEA, Health Canada, etc.) in testing a wide variety of compounds, including but not limited to pharmaceuticals, biologicals, medical devices, industrial chemicals, agrochemicals, nutraceuticals, food additives, cosmetics and petroleum products.

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Chemical Stability Testing

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DNA Services

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Product Stability Testing

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Laboratory and Facility Management Services

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Regulatory Affairs Consulting

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Animal Cognition & Behavior Tests

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Radiotracers and Radiopharmaceuticals

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Biospecimens

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In vivo Immunotoxicity Testing

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Regulatory guidelines recommend incorporation of immunotoxicity assessments within preclinical and clinical studies. Charles River conducts immunotoxicity assessments in relevant animal models, either as part of a toxicology study or as a stand-alone service. We offer a complete panel of GLP-validated immunotoxicology assays,... Show more »

Regulatory guidelines recommend incorporation of immunotoxicity assessments within preclinical and clinical studies. Charles River conducts immunotoxicity assessments in relevant animal models, either as part of a toxicology study or as a stand-alone service. We offer a complete panel of GLP-validated immunotoxicology assays, including development, validation and sample analysis for antidrug antibodies as part of preclinical and clinical safety assessments of peptide and protein therapeutics.

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Biochemical Assays

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Genetic Engineering

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Cryostorage and Cryoprocessing

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Drug Development Consulting

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In vivo Phototoxicity Testing

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Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the... Show more »

Our scientists have pioneered the quantitative study of cutaneous photobiology by designing instruments, techniques and protocols now accepted as industry standards. Expert knowledge of light sources, including xenon arc solar simulators and fluorescent sources, informs our ability to accurately control these sources. We serve the pharmaceutical, chemical and agrochemical industries with in vivo and in vitro study designs that meet not only standard, but specialized requirements for evaluation of any test material.

Qualitative and quantitative phototoxicology in mice, rats and guinea pigs
- Photoallergy studies, including photoactivated sensitizers
- Safety assessment of photodynamic drugs
- Safety assessment of unique light sources
- Expertise in ocular phototoxicity in rats and rabbits
- Board-certified veterinary ophthalmologists
- Experienced ophthalmic pathologists
- Light exposure (UVR, visible, near-infrared) under surgical conditions
- Assessment of potential damage to thoracic and abdominal organs

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Animal Glucose and Insulin Tolerance Testing

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Glucose Tolerance in Rodents
The glucose tolerance test (GTT) is valuable as a primary in vivo screening assay. This test can be used to assess the ability of your compound to enhance glucose handling following acute or chronic administration in rodents. With quick study initiation and rapid turnaround times on data... Show more »

Glucose Tolerance in Rodents
The glucose tolerance test (GTT) is valuable as a primary in vivo screening assay. This test can be used to assess the ability of your compound to enhance glucose handling following acute or chronic administration in rodents. With quick study initiation and rapid turnaround times on data generation, the GTT can collect information on gut hormone responses, changes in hepatic glucose output and whole-body glucose disposal in the postprandial state. A quick go/no-go on an inexpensive platform, it is ideal for investigating multiple routes of compound and glucose administration (PO, IP, IV, SC and IM) to move your discovery program to the next step in short order.

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Drug Preformulation

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Bioparticle Technology

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De Novo Drug Design

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Clinical Drug Management

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Protein Purification

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In vitro PK/PD Studies

In vitro pharmacokinetics/pharmacodynamics
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In vitro PK screening

Charles River can aid in the design and testing of compounds targeting the lung via both the inhaled and systemic routes. At the in vitro level, specialized screens and assays relating to inhaled delivery are used. Our integrated approach to PK studies means our scientists and study directors act as... Show more »

In vitro PK screening

Charles River can aid in the design and testing of compounds targeting the lung via both the inhaled and systemic routes. At the in vitro level, specialized screens and assays relating to inhaled delivery are used. Our integrated approach to PK studies means our scientists and study directors act as the single point of contact and are engaged from formulation to data delivery.

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Diabetes Animal Models

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Mouse Models of Diabetes
Genetically altered mice are at the center of much of the drug discovery world, and metabolic disease is no exception. The ob/ob, db/db and NOD mouse models are widely used across the field as they offer a defined and robust whole-body phenotype of diabetes, with the ob/ob and db/db specifically... Show more »

Mouse Models of Diabetes
Genetically altered mice are at the center of much of the drug discovery world, and metabolic disease is no exception. The ob/ob, db/db and NOD mouse models are widely used across the field as they offer a defined and robust whole-body phenotype of diabetes, with the ob/ob and db/db specifically adding an obese phenotype to the profile. The ob/ob and db/db strains have deficiencies in the leptin signaling pathway (lacking leptin and lacking the leptin receptor, respectively), which results in an early phenotype of hyperphagia and an ensuing profile of impaired glucose tolerance, reduced insulin sensitivity, hyperglycemia (transient in the ob/ob mouse) and hyperinsulinemia. The db/db mouse is a more aggressive model of type 2 diabetes that will progress to pancreatic failure and frank diabetes.

The NOD mouse provides an animal model that is similar to the etiology of type 1 diabetes. The severe combined immunodeficiency (SCID) mutation provides a genetic background for insulitis to develop in the pancreatic beta cell by way of leukocyte infiltration, resulting in a type 1 diabetic-specific phenotype of glycosuria and hyperglycemia.

All these mouse models are well suited for assessment of drug candidates in a chronic (2–4 week studies are common among discovery groups) setting paired with oral glucose tolerance tests and drug target-specific biomarkers, as well as advanced histological endpoints. Whether your group is looking to screen compounds to identify a lead candidate or dive deeper into mechanism-of-action studies to prepare for IND submission, these mouse models are useful tools that our scientists have relied on for years to help clients move towards the clinic.

Rat Models of Diabetes
The Zucker Fatty rat (ZFR) and the Zucker Diabetic Fatty (ZDF) rat have been used in metabolic disease research for decades. With related phenotypes of metabolic disease centered around impaired leptin signaling, these strains can be used to provide a rich dataset for investigators looking to assess the efficacy of lead candidate therapies for this multifactorial disease.

The ZDF strain initially presents as modestly hyperglycemic, but profoundly hyperinsulinemic, representing a state of considerable insulin resistance. Over time, the pancreas becomes exhausted, insulin secretion decreases (as it does in human diabetics) and plasma glucose increases in the face of insulin resistance.

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Mouse Rat Diabetes Drug Discovery Toxicology

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In Vitro Skin Corrosion Test

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

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

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

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

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Osteoporosis Animal Models

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Xenograft Models

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Osteoarthritis Animal Models

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Particle Analysis and Characterization

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In vitro Genotoxicity Testing

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Cell-Based Assays

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In vivo Genotoxicity Testing

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Rabbit Mouse Rat Minipig

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Chemistry, Manufacturing and Controls (CMC)

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In vivo Toxicity Testing

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SEND Data Conversion

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Drug Discovery & Development

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Veterinary Molecular Diagnostics

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Charles River offers molecular pathology services that include in situ hybridization (ISH), real-time PCR (rt-PCR) and quantitative PCR (qPCR), performed by a staff with a strong background in molecular biology and histopathology. This integration means we can relate gene expression to tissue histomorphology in both normal tissues... Show more »

Charles River offers molecular pathology services that include in situ hybridization (ISH), real-time PCR (rt-PCR) and quantitative PCR (qPCR), performed by a staff with a strong background in molecular biology and histopathology. This integration means we can relate gene expression to tissue histomorphology in both normal tissues and therapeutic models of disease, providing valuable functional genomics information. The end result is the best possible interpretation and troubleshooting of molecular-based tools applied to toxicological pathology issues.

  • Procurement, embedding and sectioning of study tissues
  • Synthesis of DNA and RNA probes (isotopic and non-isotopic)
  • Optimized hybridization
  • Histological evaluation by board-certified pathologists
  • Reporting with representative color photomicrographs
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qPCR real-time PCR in situ hybridization (ISH)

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Biospecimen Management and Storage

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Protein Services

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Premarket Approval Application

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Process Consulting

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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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Human Biobanking

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Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of... Show more »

Research records and materials are vital to your drug development program. It is fundamental that they be properly stored in an GxP compliant archive facility that enables reliable and rapid retrieval.
Our facilities and services provide short- and long-term GxP-compliant data and sample archiving services in support of preclinical and clinical studies for government and private sector businesses, organizations and consortia.
By archiving with Charles River you get:
- Expedited retrieval of records for agency/client inspections
- Site visits and on-site access to Study Directors
- Full service record keeping from inception to destruction

Facilities and Services:
- Over 500,000 cubic feet of controlled, dedicated space
- Several layers of security to limit access as well as safeguard essential study materials under GLP conditions
- Storage conditions include room temperature, refrigerated, frozen at -20°C or -70°C and cryostorage at -196°C
- Periodic inventory and materials inspections
- Hard copy transfer to CD
- Microform printing
- Pick-up and delivery services for both short-term and long-term storage

Specimens/Materials:
- Paper data, records and reports
- Electronic media
- Microform
- Pathology samples (e.g., wet tissues, frozen tissues, paraffin and plastic blocks)
- Microslides
- Test articles
- Medical records
- Vaccines
- Biological samples
- Radioactive material

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In vitro Percutaneous Absorption Studies

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In vitro Metabolic Stability Assays

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Obesity Animal Models

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Rodent models chronically fed high-fat diets provide a unique opportunity to assess a compound’s ability to treat obesity and related outcomes in a wide range of manners. Through the use of specific diets, appropriate positive controls and a robust suite of analytical endpoints, researchers can hone in on certain aspects of... Show more »

Rodent models chronically fed high-fat diets provide a unique opportunity to assess a compound’s ability to treat obesity and related outcomes in a wide range of manners. Through the use of specific diets, appropriate positive controls and a robust suite of analytical endpoints, researchers can hone in on certain aspects of obesity and related metabolic syndrome endpoints. Be it as simple as a change in body weight gain or as complicated as whole-body calorimetry, body composition, accurate acute food intake and a range of histological markers, our Discovery Services group can accommodate your study design.

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Mouse Rat Rodents Obesity Drug Discovery

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In vitro Skin Models

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Subcellular Fractionation

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Cell Fractionation Services

Cell Fractionation Services

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Vaccine Production

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Biomolecular Interaction Analysis

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In vivo Bioavailability/Bioequivalence Studies

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Biopharmaceutical Process Development

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Animal Physiology Analyses

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Custom Manufacturing

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Dose Range Finding (DRF) Studies

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Metabolic Animal Models

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Biopharmaceutical Manufacturing

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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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Yeast Bacteria Fungi mold filamentous fungi Mycoplasma PCR MLST Multi-Locus Sequence Typing 16S rDNA sequencing ITS2 rDNA sequencing MALDI-TOF Mass Spec SLST isolate storage isolate preservation Bacteria Yeast Fungi Mold filamentous fungi Show 20 more tags Show less

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Clinical Trials Supply Manufacturing

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Specialized Cell-Based Assays

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In vivo Biologic Potency Testing

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Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. We can aid in the development of an in vivo potency assay through range-finding studies using investigation parameters (e.g., dose level and route of administration), followed by validation and implementation. We also... Show more »

Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. We can aid in the development of an in vivo potency assay through range-finding studies using investigation parameters (e.g., dose level and route of administration), followed by validation and implementation. We also conduct in vivo bioassays to show efficacy and safety. These assays include adjuvant assessment, lot release potency testing, bacterial and vaccine challenge studies, and stability testing for a diverse range of products, including hormones, vaccines, neurotoxins, allergens, antivenom, bacteria and blood products.

In vitro bioassays can also be used to determine the potency of a biopharmaceutical by comparing the biological response related to its mode of action with that of a control preparation. We offer cell-based bioassays for the determination of potency of many types of products, including EPO, PTH, G-CSF, GM-CSF, interferon and multiple monoclonal antibodies. With extensive experience developing bioassays for monoclonal antibodies, we can readily support the analysis of biosimilars and adapt or optimize existing assays to suit the needs of a particular product.

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Biopharmaceutical Manufacturing

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Clinical Trials, Consulting, and Management

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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 ADME Drug Discovery

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In vitro Biologic & Biosimilar Toxicity Screening

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Mammalian Cell Culture

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In vivo Biologic & Biosimilar Toxicity Screening

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Mouse Rat Minipig

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Oncology Animal Models

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Drug Release Studies/In Vitro Release Testing (IVRT)

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Regulatory Affairs Services

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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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ICH Stability Testing

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Cell and Tissue Culture

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Microbiology Assays

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Animal Immunization for Antibody Production

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Rabbit Goat Chicken

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Clinical Research

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Analytical Validation

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Veterinary Laboratory Services

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Sterility Testing

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Sterility testing is designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use. The sterility test is applied to substances, preparations or articles, which, according to the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP),... Show more »

Sterility testing is designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use. The sterility test is applied to substances, preparations or articles, which, according to the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP), are required to be sterile. Sterility testing is used for bulk and final drug products, cell banks and raw materials. Charles River provides sterility testing that is compliant with both USP and EP regulations. Sterility testing is conducted on bulk or final products by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment. A bacteriostasis/fungistasis test is also performed to assess whether or not the test article inhibits the growth of microorganisms. The performance of bacteriostasis and fungistasis testing is necessary in order to validate the sterility result and confirm that there are no antimicrobial properties within the test article that would inhibit the detection of microbial organisms during the sterility assay.

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GMP Sterility Testing (USP <71>) Membrane Filtration Direct Inoculation Sterility Validation Bioburden Test Method Validation Bioburden Testing Show 7 more tags Show less

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Bioanalysis

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Pyrogen Testing

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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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Model Organisms

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Marketing, Communication & Graphic Design Services

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Monocyte Activation Testing

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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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Immunobiology Services

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Endotoxin Testing

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Through the Charles River process manufacturing support network, endotoxin and pyrogenicity testing can be performed in conjunction with other assays meant to detect potential contaminants in products and raw materials. This testing is a vital step in gaining market approval for products. A number of different testing methods are... Show more »

Through the Charles River process manufacturing support network, endotoxin and pyrogenicity testing can be performed in conjunction with other assays meant to detect potential contaminants in products and raw materials. This testing is a vital step in gaining market approval for products. A number of different testing methods are offered to ensure that clients are able to select the option most conducive to their pyrogen and endotoxin detection needs.

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GMP in vitro LAL in vivo Monocyte activation testing

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Virology Services

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Accelerated Stability Testing

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Host Cell Protein (HCP) Detection

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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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DNA Hybridization

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Residual DNA Analysis

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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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In vivo Pharmacology Studies

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In vivo Pharmacology Studies Services

In vivo Pharmacology Studies Services

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Pharmacology

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Pharmacology Services

Pharmacology Services

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Residual Impurity Analysis

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

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Omics

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In vitro Biologic Potency Testing

Price on request

Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. We can aid in the development of an in vivo potency assay through range-finding studies using investigation parameters (e.g., dose level and route of administration), followed by validation and implementation. We also... Show more »

Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. We can aid in the development of an in vivo potency assay through range-finding studies using investigation parameters (e.g., dose level and route of administration), followed by validation and implementation. We also conduct in vivo bioassays to show efficacy and safety. These assays include adjuvant assessment, lot release potency testing, bacterial and vaccine challenge studies, and stability testing for a diverse range of products, including hormones, vaccines, neurotoxins, allergens, antivenom, bacteria and blood products.

In vitro bioassays can also be used to determine the potency of a biopharmaceutical by comparing the biological response related to its mode of action with that of a control preparation. We offer cell-based bioassays for the determination of potency of many types of products, including EPO, PTH, G-CSF, GM-CSF, interferon and multiple monoclonal antibodies. With extensive experience developing bioassays for monoclonal antibodies, we can readily support the analysis of biosimilars and adapt or optimize existing assays to suit the needs of a particular product.

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Potency Assay GMP Stability Indicating Methods Drug Product Release Biosimilarity analysis In vivo bioassays In vitro bioassays Show 7 more tags Show less

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Spectrophotometry

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Structural Biology

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Lot Release Testing

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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.

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GMP Drug Product Release

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Veterinary Research & Diagnostics

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Product Development, Testing, and Packaging

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Viral Clearance Assays

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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.

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

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Microbiology

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Adventitious Agent Testing

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The biosafety package for any biopharmaceutical product must include a comprehensive plan for the detection of endogenous and adventitious viral agents. Charles River offers a portfolio of in vivo, in vitro and biochemical viral safety assays. Assays can be chosen and customized to address your specific concerns and needs,... Show more »

The biosafety package for any biopharmaceutical product must include a comprehensive plan for the detection of endogenous and adventitious viral agents. Charles River offers a portfolio of in vivo, in vitro and biochemical viral safety assays. Assays can be chosen and customized to address your specific concerns and needs, ensuring that an appropriate testing plan is designed for your product. Fast Track Testing is also available for quick delivery of urgently needed results.

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PCR qPCR Cell-based assays GMP In vivo assays in vitro assays murine antibody production hamster antibody production MAP HAP adventitious agent testing PAA BAA XC plaque S+L- co-cultivation retrovirus detection assays porcine adventitious agents bovine adventitious agents Show 19 more tags Show less

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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 adventitious agent testing inapparent virus abnormal toxicity general safety Vaccines Show 11 more tags Show less

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Equipment

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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
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In vitro Biosafety Testing

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The biosafety package for any biopharmaceutical product must include a comprehensive plan for the detection of endogenous and adventitious viral agents. Charles River offers a portfolio of in vivo, in vitro and biochemical viral safety assays. Assays can be chosen and customized to address your specific concerns and needs,... Show more »

The biosafety package for any biopharmaceutical product must include a comprehensive plan for the detection of endogenous and adventitious viral agents. Charles River offers a portfolio of in vivo, in vitro and biochemical viral safety assays. Assays can be chosen and customized to address your specific concerns and needs, ensuring that an appropriate testing plan is designed for your product. Fast Track Testing is also available for quick delivery of urgently needed results.

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qPCR Cell-based assays GMP adventitious agent testing retrovirus detection assays porcine adventitious agents bovine adventitious agents Show 7 more tags Show less

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Biopharmaceutical Characterization

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All new biological products need to be characterized prior to inclusion in a clinical trial. The physicochemical characterization of the product includes a range of analytical and molecular methods to elucidate the primary and secondary structure. We support the development of complex biologics and biopharmaceuticals through... Show more »

All new biological products need to be characterized prior to inclusion in a clinical trial. The physicochemical characterization of the product includes a range of analytical and molecular methods to elucidate the primary and secondary structure. We support the development of complex biologics and biopharmaceuticals through expertise in structural and functional characterization programs for inclusion in regulatory filings in the United States, Europe and Japan. Here are some of the the services:

Mass spectrometry
Biophysical characterization
Glycosylation/Glycan characterization
Chromatography & electrophoretic methods
N-terminal sequencing and amino acid analysis
ELISA and immunoassay development
Potency assays
Glycoprotein characterization
Protein Glycosylation characterization
Liposomal product characterization

Biopharmaceutical Stability Testing

Biological products have distinguishing characteristics, and the quality of these products must be tested under a variety of environmental factors (e.g. temperature, humidity, light) in order to confirm their stability during the intended storage period. We provide drug substance and final product stability testing and storage services in compliance with current International Conference on Harmonisation (ICH) guidelines to support clinical studies, license applications and post-marketing commitments.

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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 glycoprotein characterization Show 12 more tags Show less

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Clinical Chemistry

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Electrophysiology

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Electrophysiology Services

Electrophysiology Services

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Protein Characterization

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

To help clients generate the data needed to gain the level of product characterization required for regulatory submission, Charles River offers protein analysis as part of an integrated package of expert analytical services. We have extensive experience in developing and establishing protein characterization methods, including product-specific in vitro potency assays. These characterization services are also a part of our stability and product release support services, where we offer key identity, purity and potency assays.

Analytical Serrvices:
Mass spectrometry
Biophysical characterization
Glycosylation/Glycan characterization
Chromatography & electrophoretic methods
N-terminal sequencing and amino acid analysis
ELISA and immunoassay development
Potency assays

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Immunoassays Potency Assay western blot SDS-PAGE GMP N-terminal Sequencing DLS (Dynamic Light Scattering) Amino Acid Analysis Circular Dichroism Peptide Map IEF Osmolality Residuals Biosimilarity analysis 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 Biacore Show 25 more tags Show less

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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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Genotyping Services

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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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Protein Biophysical Characterization

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Many of our biophysical characterization methodologies examine a product's higher-order structure (HOS), which may include secondary and tertiary structure, aggregation and oligomerization. Correct HOS configuration is critical to ensure proper functionality, activity and stability of a biopharmaceutical product. Secondary and HOS... Show more »

Many of our biophysical characterization methodologies examine a product's higher-order structure (HOS), which may include secondary and tertiary structure, aggregation and oligomerization. Correct HOS configuration is critical to ensure proper functionality, activity and stability of a biopharmaceutical product. Secondary and HOS characterization capabilities are essential for a complete product characterization program.

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HPLC-SEC GMP DLS (Dynamic Light Scattering) Circular Dichroism FTIR Differential Scanning Calorimetry (DSC) Biosimilarity analysis Analytical Ultracentrifugation intrinsic tryptophan fluorescence extrinsic fluorescence surface plasmon resonance (SPR) Biacore Show 12 more tags Show less

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Biochemistry & Molecular Biology

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Ion Channel Screening Assays

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Charles River works collaboratively with our partner’s to enable them to translate ion channel discoveries into tomorrow’s 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... Show more »

Charles River works collaboratively with our partner’s to enable them to translate ion channel discoveries into tomorrow’s 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® / Hamamatsu FDSS)
- IonWorks® Quattro and IonWorks® Barracuda™ screens of up to 125,000 compounds per target (voltage-gated and ligand-gated ion channels)
- Conventional as well as PatchXpress® and QPatch HT® 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

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Drug Discovery FLIPR® / Hamamatsu FDSS IonWorks® Quattro IonWorks® Barracuda™ PatchXpress® QPatch HT® Show 6 more tags Show less

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Imaging & Spectroscopy

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Protein Formulation

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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... Show more »

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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formulation development

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Computational Modeling

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Liposome Characterization

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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
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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Cardiac Channel Assays

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Automated or conventional (manual patch clamp) screening and concentration-response (IC50) assays in panels of cardiac ion channels provide a rapid, comprehensive evaluation of multiple ion channel effects (MICE) for greater insight into potential cardiac risk and more effective decision-making in early preclinical... Show more »

Automated or conventional (manual patch clamp) screening and concentration-response (IC50) assays in panels of cardiac ion channels provide a rapid, comprehensive evaluation of multiple ion channel effects (MICE) for greater insight into potential cardiac risk and more effective decision-making in early preclinical development.
Assay Benefits:
Complements S7B integrated cardiac risk assessment
Provides mechanistic interpretation
Predicts proarrhythmia potential
Fully validated by expert electrophysiologists
Cardiac Channel Panel includes: Cav1.2 (ICa,L), Cav3.2 (ICa,T), HCN2, HCN4, hERG (IKr), Kir2.1 (IK1), Kir3.1/3.4 (IK,Ach), Kir6.2/SUR2A (IK,ATP), Kv1.5 (IKur), Kv4.3 (ITO), KvLQT1/minK (IKs) and Nav1.5 (INa).

Charles River also offers SaVety™ assessment, which applies a logistic regression model to predict torsadogenic risk from ion channel IC50 data. As a result, the SaVety™ assessment provides more confidence than ever regarding the risk profile of compounds before going into animal and/or human studies and aligns with the recommendations of the comprehensive in vitro proarrhythmia assay (CiPA).

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Glycosylation Analysis

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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 MSn
Glycan Profile / Isoform via cIEF
Exoglycosidase Glycan Sequence / Mapping

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

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Functional Human Tissue Assays

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Cell Line Products - Ion Channels

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The ChanTest 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 ChanTest 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.
Please send us a message or request a quote for the the latest portfolio and pricing information or to speak with one of our experts.

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HEK293 CHO cell lines

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Separation/Purification Services

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Nucleic Acid Services

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Rat Models

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Chromatography

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Synthetic Chemistry

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Microscopy

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Environmental Science

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Chemistry and Materials

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Biomarkers

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Vitamin Measurement in Human Samples

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Clinical Validation of Diagnosis

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UV-VIS Spectroscopy

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Document Translation

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Toxicology

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Computer Science, Software Development, and IT Services

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Bone/Cartilage Animal Models

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Quality Assurance

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Contract Services Directory

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PCR

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Pharmacogenomics/Pharmacogenetics

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Testing of Cell Lines

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Mycoplasma Testing

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Microscopic Analysis

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Animal Plasma and Serum

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Rodent Models

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Microbiology Testing

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Clinical Validation Services

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Product Testing Services

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Mass Spectrometry

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Laboratory Information Management Systems (LIMS)

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Medical Devices & Diagnostics

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Data Collection

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Hit Identification

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HPLC

High Performance Liquid Chromatography
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In vivo Drug Efficacy Testing

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High Throughput Screening (HTS)

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Clinical Supply Chain Management and Logistics

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Data Management

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In vivo Gene Delivery Studies

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MRI guided AAV injections

MRI guided AAV injections

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Phase IV Clinical Trials

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Animal Cerebrospinal Fluid Collection

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CSF sampling (lateral ventricle, cisterna magna, lumbar puncture) in NHPs

CSF sampling (lateral ventricle, cisterna magna, lumbar puncture) in NHPs

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Nonhuman Primate

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Phase III Clinical Trials

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Phase II Clinical Trials

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Spontaneous Locomotor Activity Test

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Phase I Clinical Trials

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Clinical Trial Management

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Clinical Sample Analysis

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Gas Chromatography (GC)

Gas Chromatography
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Terrestrial Toxicity Testing

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Terrestrial Toxicity Testing Services

Terrestrial Toxicity Testing Services

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Animal Motor Function Tests

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In vivo Studies

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Animal Biospecimen Collection

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Drug Absorption Studies

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