Immunogenicity: anticipating and avoiding issues for biopharmaceutical development

NDA Advisory Board member, Paul Chamberlain, has just had an article titled Immunogenicity: anticipating and avoiding issues for biopharmaceutical development, published in Drug Target Review.
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 not be compromised if these risks are suitably evaluated from the earliest stages of development.

 

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