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Charles River - Laboratory Sciences

Our Laboratory Sciences team balances scientific integrity, cost-effectiveness and regulatory compliance within the most stringent of time frames to deliver comprehensive support throughout the drug development process. Our global capabilities ensure that you have the resources necessary to handle all your laboratory support needs, or simply to supplement your in-house capabilities.

We believe in remaining at the forefront of laboratory technology and have made significant investments in highly trained chemists, facilities and instrumentation to produce rapid and reliable data.

Comprehensive bioanalytical service support is key at every stage of product development in discovery, preclinical and clinical programs. Our worldwide bioanalytical laboratories use a range of techniques and technology platforms to ensure that we can support you with rapid lead-in times in order to meet critical deadlines.

Our... Show more »

Our Laboratory Sciences team balances scientific integrity, cost-effectiveness and regulatory compliance within the most stringent of time frames to deliver comprehensive support throughout the drug development process. Our global capabilities ensure that you have the resources necessary to handle all your laboratory support needs, or simply to supplement your in-house capabilities.

We believe in remaining at the forefront of laboratory technology and have made significant investments in highly trained chemists, facilities and instrumentation to produce rapid and reliable data.

Comprehensive bioanalytical service support is key at every stage of product development in discovery, preclinical and clinical programs. Our worldwide bioanalytical laboratories use a range of techniques and technology platforms to ensure that we can support you with rapid lead-in times in order to meet critical deadlines.

Our experienced scientists develop, validate and apply quantitative methods to measure drug and metabolite concentrations for samples in plasma, serum, cerebrospinal fluid (CSF), urine and tissue. Our comprehensive services can be performed on small molecules and large molecules, including antibody-drug conjugates, biosimilars, monoclonal antibodies, oligonucleotides, peptides, proteins and vaccines.

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Biochemistry & Molecular Biology
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Charles River performs a comprehensive array of genomics-based assays to support all phases of drug development, from discovery and preclinical studies through clinical trials, in either singleplex or multiplex formats. Our molecular biology facilities have custom-designed, dedicated laboratories with separate sample processing... Show more »

Charles River performs a comprehensive array of genomics-based assays to support all phases of drug development, from discovery and preclinical studies through clinical trials, in either singleplex or multiplex formats. Our molecular biology facilities have custom-designed, dedicated laboratories with separate sample processing (nucleic acid extraction), reagent preparation and amplification/product detection areas to minimize the possibility of cross-contamination.
We isolate and purify DNA and RNA from a variety of tissues, body fluids and cells in culture. Our extraction procedures are optimized to provide the highest quality real-time qPCR results; both quality and yield of extracted nucleic acid samples are assessed prior to being used.

Services:
- Nucleic acid therapeutic assessments
- Gene expression analysis
- Cytokine mRNA profiling in immune response
- Biomarker assessment
- Real-time quantitative and reverse transcriptase PCR
- Reporter gene assays
- Genomic and plasmid DNA isolation
- Residual mammalian DNA detection by hybridization analysis
- Assay feasibility, development and validation
- Biological sample analysis
- GLP/non-GLP study designs and reporting

Technical Capabilities:
- Real-time PCR platforms capable of supporting multiple fluorescent chemistries
- Luminex®-based QuantiGene® system
- Bioluminescent reporter gene assays
- Allelic discrimination assays (TaqMan® probe chemistry)

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Biomarker Discovery
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The identification and use of predictive biomarker assays has become an integral part of the drug discovery and development process. Charles River has broad expertise in biomarker identification and assay development across a range of therapeutic areas, including respiratory disease, oncology, CNS and metabolic... Show more »

The identification and use of predictive biomarker assays has become an integral part of the drug discovery and development process. Charles River has broad expertise in biomarker identification and assay development across a range of therapeutic areas, including respiratory disease, oncology, CNS and metabolic diseases.
Capabilities span the identification and validation of biomarkers and the development of quantitative assays in primary cells and disease tissue, pharmacodynamic and disease models, and as efficacy and translational medicine markers in the clinic. Our experience includes the translation of biomarker assays for use in the clinic for several client projects.

Example Readouts:
- Proteomic markers
- Genomic markers
- Phosphoprotein markers
- Epigenetic markers

Assay Techniques:
- MesoScale for multiplexed immunoassay endpoints
- FACS analysis
- Mass spectrometry

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Biopharmaceutical Characterization
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Biomarker Analysis
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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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Ligand Binding Assays
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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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Bioanalytical Assays
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Charles River offers substantial capacity and expertise in the highly sensitive and precise technique of chromatographic and mass spectrometric bioanalysis. We have validated the quantitation of NCE drugs, metabolites and biomarkers from a wide variety of biological matrices. Rapid sample analysis delivers reliable results on time... Show more »

Charles River offers substantial capacity and expertise in the highly sensitive and precise technique of chromatographic and mass spectrometric bioanalysis. We have validated the quantitation of NCE drugs, metabolites and biomarkers from a wide variety of biological matrices. Rapid sample analysis delivers reliable results on time for any project, ranging from nonclinical studies through Phase I-IV clinical programs. In addition to traditional pharmaceutical bioanalysis, our laboratories are equipped to handle industrial and agrochemical applications.
The scientists in our 7 laboratories located throughout North America, the United Kingdom and mainland Europe analyze over 250,000 samples per year. With decades of experience, our scientists collaborate directly with you, providing solutions tailored to your molecule and program.

Capabilities:
- High-throughput PK
- Lead optimization, non-GLP PK
- Method development, validation and rapid transition of methods between species and matrices according to regulatory guidelines
- Method transfer/cross validation utilizing quality controls and/or incurred study samples
- Watson LIMS™ data management

Nonclinical (GLP) and clinical (GCP) sample analysis:
- Nonclinical and clinical PK sample analysis
- Bioequivalency studies
- Therapeutic drug monitoring studies
- Drug-drug interaction study support with validated multi-analyte methods
- Biomarker measurements
- GLP/GCP whole blood, plasma, serum, tissue, urine and cerebral spinal fluid sample analysis
- Analyte stabilization techniques

Large molecule quantitation by LC-MS:
- Immunoaffinity capture
- Digested
- Multiple reaction monitoring (MRM) and intact MS
- Peptides, proteins, oligonucleotides, antibody-drug conjugates

Platforms:
- Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
- Liquid chromatography-high resolution mass spectrometry (LC-MS, HRMS)
- Liquid chromatography (HPLC, UHPLC) with UV, fluorescence, ELSD and radiolabelled detection*
- Gas chromatography (GC) with MS, MS/MS, FID and EC detection
- Inductively coupled plasma (ICP-OES, ICP-MS)

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Bioanalytical Assay Development and Optimization
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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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Drug Formulation Development
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Formulation development services range from preformulation investigations to analytical method development and validation. Charles River prepares formulations based on our extensive knowledge of vehicle suitability in animal models. Formulation types include oral, parenteral, inhalation and radiolabeled. Bulk test articles are... Show more »

Formulation development services range from preformulation investigations to analytical method development and validation. Charles River prepares formulations based on our extensive knowledge of vehicle suitability in animal models. Formulation types include oral, parenteral, inhalation and radiolabeled. Bulk test articles are analyzed to determine identity, purity and stability to support GLP preclinical studies.
Adhering to strict regulatory guidelines, dedicated staff within several facilities control test article receipt, storage, distribution, use and disposition with a barcode system designed for identifying and monitoring materials.

Formulation Development:
- pH solubility profiling assessments
- Dose suitability
- Compatibility
- Bioavailability enhancement

Analytical Chemistry:
- High performance liquid chromatography (HPLC)
- Ultra-high performance liquid chromatography (UPLC)
- Gas chromatography (GC)
- Liquid chromatography/mass spectrometry (LC-MS and LC-MS/MS)
- Atomic absorption spectroscopy (AAS)
- UV/Vis spectroscopy
- Fourier transform infrared (FTIR) spectroscopy
- Capillary electrophoresis (CE)
- Karl Fischer titration
- Inductively Coupled Plasma (ICP-OES, ICP-MS)

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Clinical Sample Kits
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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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Clinical Sample Analysis
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Charles River offers a broad range of laboratory services to support clinical trials. We provide high-quality assays and testing support for your drug development programs, and focus on assay and testing services that transition easily from nonclinical laboratory testing into the clinical phase. The members of our scientific staff... Show more »

Charles River offers a broad range of laboratory services to support clinical trials. We provide high-quality assays and testing support for your drug development programs, and focus on assay and testing services that transition easily from nonclinical laboratory testing into the clinical phase. The members of our scientific staff have extensive experience in transferring and developing methods efficiently and expeditiously.

In many cases, our staff get involved at the start of the nonclinical program and stay on through testing, collaborating as part of the clinical study team. This approach results in robust and reliable methods for clinical sample analysis, which, when combined with data management and data transfer expertise, enables us to produce high-quality, on-time clinical data to support drug approval, and to help you effectively make sound go/no-go decisions.

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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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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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Immunoassays
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Clinical Immunology Tests
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Clinical Research
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Clinical Laboratory Services
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Pharmacology & Toxicology
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Manufacturing
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Bioanalysis
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Formulation & Manufacturing
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Biology
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Clinical Sample Services
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Biomolecular Interaction Analysis
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Biomarkers
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