Immunotoxicology and Immunophenotyping
Evaluation of effects on immune function is an essential component of safety evaluation of new drugs and biotechnology products. Changes in immunity may signify toxic side effects or desired clinical effects of drugs. Immunologic assessments are important end points for evaluating drug or chemical impact on human health
MDS offers immunology and immunotoxicology program tailored to the needs of the biopharmaceutical industry. We can assist you in identifying cost-effective approaches to immunologic characterization of the new drugs based on drug's mechanism, history, and future clinical use. At your request, consulting services are also available.
Enhanced immune evaluations are often needed for small-molecule synthetic drugs, peptides, and nucleic-acid-based biotherapeutics such as antisense agents, as well as biotechnology products (e.g., recombinant human proteins), especially those for broad or chronic human use or for use in sensitive populations. When built into toxicology studies, immune end points are valuable for understanding of expected human target doses.
Immunotoxicity, immunoefficacy and immunophenotyping can be assessed using in vitro and in vivo assays of immune function. The following assays are currently available:
In Vivo Evaluation of Immune Response
- Protein toxicokinetics,
- Anti-drug antibody monitoring,
- Immunogenicity testing,
- Hypersensitivity testing
- Host resistance assays
- Inflammation and asthma models
- Innate Immunity
- Developmental immunotoxicity testing
- Flow cytometry
- Immunohistochemistry
- ELISA
- T-Cell Function
- B-Cell Function
- Cytokine quantitation
- Functional assays
- T-cell-dependent or vaccine-induced antibody responses
- Neutralizing antibody and other cell-based assays
- Molecular biology assays, including real-time PCR assays
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