Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins




DRAFT GUIDANCE: This guidance provides recommendations to facilitate industry’s development of immune assays for assessment of the immunogenicity of therapeutic proteins during Clinical Trials.

This document includes guidance for binding assays, neutralizing assays, and confirmatory assays. While the document does not specifically discuss the development of immune assays for animal studies, the concepts discussed are relevant to the qualification and validation of immune studies for preclinical evaluation of data.

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