article
Immunogenicity: anticipating and avoiding issues for biopharmaceutical development
All biopharmaceutical products are associated with an intrinsic potential to…
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…