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.

In general, this document does not discuss the rationale for ADA testing or the subject- and product-specific risk factors that may contribute to immunogenicity. Also, this guidance, including any discussions of terminology used in this guidance, does not apply to in vitro diagnostic products.

Posted on the FDA website on 23 January 2019