Tuesday, 26 March 2019

FDA: Immunogenicity Testing of therapeutic protein products


FDA have issued a new draft guidance for developing and validating assays for anti-drug antibody detection.

This guidance provides recommendations to facilitate industry’s development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. Specifically, this document includes guidance regarding the development and validation of screening assays, confirmatory assays, titration assays, and neutralization assays. For the purposes of this guidance, immunogenicity is defined as the propensity of a therapeutic protein product to generate immune responses to itself and to related proteins or to induce immunologically related adverse clinical events. The recommendations for assay development and validation provided in this document apply to assays for the detection of one or more anti- drug antibodies (ADAs). This guidance may also apply to some peptides, oligonucleotides, and combination products on a case-by-case basis. 

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629728.pdf   

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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