Immunologic assessments are important end points for evaluating drug or chemical impact on human health. Changes in immunity may signify toxic side effects or desired clinical effects of drugs. Also, biotechnology products (e.g., recombinant human proteins) often trigger immune reactions in animals that have far-reaching effects on toxicology or clinical approaches.
Immune end points 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 end points can lend unique insight into expected human target doses and accelerate clinical trials for immunomodulatory substances.
Charles River employs over 100 scientists within our dedicated immunology laboratories. Our labs 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 immunology services to consider, including:
- Immune tissues, morphologic pathology
- Immunochemistry (ELISAs), including protein toxicokinetics, immunogenicity testing, and biomarker quantitation (e.g., cytokine, chemokine, complement factors)
- Flow cytometry
- Functional assays
- T-cell-dependent antibody responses
- NK cell and neutrophil function assays
- Neutralizing antibody
- Proliferation assays
- Customized assays
- Developmental immunotoxicity testing
- Hypersensitivity testing
- Host resistance assays
- Inflammation and asthma models
- Molecular biology assays, including real-time PCR assays