Anti-drug antibody (ADA) assessment is an integral part of biotherapeutic drug development, providing critical information about potential immunogenicity risks and their impact on drug safety and efficacy. To support development of complex biologic products, it is necessary to understand the unique considerations for use of ADA assays in early development, pre-clinical and clinical settings.
Download this article to learn the key aspects of ADA assays that are relevant for each phase of development and the parameters for achieving results that support successful decision-making when developing biologic products.