FDA Issues Final Guidance: Immunogenicity Testing of Therapeutic Protein Products

Last week, the FDA released a final guidance document entitled, “Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection”.  This final guidance is based on a draft guidance issued in April 2016 and the comments received during the industry review period.  This guidance contains recommendations for the development and validation of assays detecting one or more anti-drug antibodies.  There is also information regarding screening assays, confirmatory assays, tittering assays, and neutralization assays.

The FDA recommends utilizing a risk-based approach when evaluating and managing immune responses to therapeutic protein products that affect their pharmacokinetics, pharmacodynamics, safety, and efficacy.  Immunogenicity tests should be designed to detect ADA (anti-drug antibodies) that could mediate unwanted biological or physiological consequences.  This guidance document reviews concepts including but not limited to assay design, assay development, assay validation, implementation of assay testing, and some tips on proper documentation.

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