Presentation Summary: Unwanted immune responses to biotherapeutics can significantly affect both patient safety and the overall efficacy of treatment. Because of these risks, it is essential to address immunogenicity early in the drug development process. Mitigation strategies should begin at the drug design stage, with the primary goal being the selection of a clinical candidate that demonstrates the most favorable immunogenicity risk profile. This presentation will discuss the non-clinical risk assessment tools available to identify and remediate product immunogenicity liabilities. It will also explore how de-risking activities are incorporated into protein engineering workflows, ensuring that potential immune responses are minimized before clinical trials begin. In addition, a brief overview of the main collaborative efforts between companies and academic institutions will be provided, highlighting the importance of working together to find effective solutions to immunogenicity challenges.

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