FDA Issues Draft Guidance on Immunogenicity Testing of Therapeutic Proteins

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-26-2016 14:29


The US Food and Drug Administration (FDA) has issued draft guidance, Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. to facilitate industry’s development and validation of immune 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, titering assays, and neutralization assays. For the purposes of this guidance, immunogenicity is defined as the propensity of the 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 detection of anti-drug antibody(ies). The guidance may also apply to some combination products on a case-by-case basis.

The guidance revises the draft guidance for industry, Assay Development for Immunogenicity Testing of Therapeutic Proteins issued in December 2009. The information in this guidance has been reorganized for clarity and includes new information on titering and confirmatory assays.

Source: US Food and Drug Administration


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