Module 9 2021

22/03/2021

Towards harmonisation of immunoassays

The Organisation for Professionals in Regulatory Affairs

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Reporting of data

Regulatory expectations for immunogenicity assessment have evolved considerably over the past decade. Reporting of data should include rationale for choice of methods & sequence of testing; assay development and validation; ADA incidence and titre; neutralizing capacity of the antibodies; kinetics of response (when onset initiated, duration of response - transient/persistent, how long ADA persist after treatment); clinical relevance and impact on PK, PD, efficacy, safety; etc Meeting regulatory expectations for ADA assessment can be a bioanalytical challenge (e.g., assay sensitivity, drug tolerance). Full assay validation packages are submitted at licence application (BLA) / marketing authorisation application (MAA) - methods not deemed validated until regulators review and agree.

The Organisation for Professionals in Regulatory Affairs

42

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