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NDA Advisory Board



Immunogenicity: anticipating and avoiding issues for biopharmaceutical development

21 September 2015 | By

All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should…