Immune endpoints should be considered in programs for a number of different kinds of drugs and biologics, particularly those for broad or chronic human use or for use in sensitive populations. In addition, enhanced immune evaluations are often needed for small molecule drugs known to have receptors in immune organs. When built into toxicology studies, these endpoints can lend unique insight into expected human target doses and accelerate clinical trials for immunomodulatory substances.
Charles River employs over 80 scientists within our dedicated immunology laboratories. Our labs also conduct GLP immunotoxicology assessments in multiple species. While no study design is “one size fits all,” our studies provide you with reports that meet the international regulatory guidelines for biotechnology-derived products (S6) and immunotoxicology (S8 – draft guideline).
Our scientific specialists can assist you in identifying cost-effective approaches to immunologic characterization. Designs for these studies arise from discussion of the drug’s mechanism, history, and future clinical use. At your request, consulting services and clinical strategy assessments are also available.
Charles River offers a broad range of immune services to consider, including:
- Clinical chemistry (immunoglobulins and complement fragments)
- Immune tissues and morphologic pathology
- Immunohistochemistry
- Immunochemistry (ELISAs)
- Protein toxicokinetics, anti-drug antibody monitoring, immunogenicity testing, and cytokine quantitation
- Flow cytometry
- Functional assays
- T-cell-dependent or vaccine-induced antibody responses (KLH, sheep RBCs, or tetanus antigens)
- NK cell or neutrophil functional activity
- Neutralizing antibody and other cell-based assays
- Developmental immunotoxicity testing
- Hypersensitivity testing
- Host resistance assays
- Inflammation and asthma models
- Molecular biology assays, including real-time PCR assays
For more information about our immunological testing capabilities, contact us at 1.877.CRIVER.1 or askcharlesriver@crl.com.
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