Rational Is Not Radical: A Scientific Perspective on Immunogenicity Risk Assessment

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Please fill out the form to access the gated web content. This article summarizes adopting a biomarker-based approach to immunogenicity assessment in bioanalytical drug development. The traditional paradigm of anti-drug antibody (ADA) assessment, which primarily focuses on binary positive/negative classification and incidence rates, is contrasted with a more comprehensive biomarker approach that examines the totality of data. By visualizing all immunogenicity data—not just ADA-positive results—in context with pharmacokinetic data, researchers can more efficiently identify clinically relevant immunogenicity, improve data interpretation, and streamline communication with key stakeholders. This approach enables faster, more informed drug development decisions focused on clinical impact rather than mere incidence rates, while simultaneously reducing organizational confusion and resource expenditure associated with traditional immunogenicity reporting.