Immune responses to therapeutic products have the potential to affect Pharmacokinetics (PK), Pharmacodynamics (PD), safety and efficacy.
Assessment of a biotherapeutics' ability to produce an immune response requires the development of customized immunoassays following a tiered approach. With a specialized team of scientists and regulatory project managers, the Immunogenicity Centre Excellence, Cambridge (Fordham), has a wealth of experience in developing and validating sensitive, specific, selective, and drug/target tolerant ADA and NAbs assays to support non-clinical and clinical immunogenicity up to Phase IV post-marketing surveillance. All validation is performed to GCP or GLP standards in line with current regulations (FDA and/or EMA).
Manufacturer Drug Development Solutions
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