Biologics and ATMPs have transformed the treatment of serious diseases, yet immunogenicity remains a key barrier to realizing their full potential. This course delivers a practical, in-depth overview of immunogenicity risk assessment and mitigation across preclinical and clinical development. Participants will gain insights into current quality and regulatory expectations, analytical assay development, and the characterization and monitoring of anti-drug antibodies (ADAs), equipping them with
The rise of biologics and ATMPs have revolutionized the treatment of many serious diseases. However, the issues of unwanted immunogenicity sometimes remain the key limitation to fully utilize their potential.Therefore, the development of biologics with decreased immunogenicity risks is of the high importance. This is, however, a very complex and multifactorial challenge, that needs to be addressed in pre-clinical and clinical development.This unique course provides a practical & in-depth understanding of immunogenicity risk assessment and risk minimization. It also brings clarifications on the latest quality & regulatory requirements for immunogenicity. You will gain insights into analytical assay development as well as into characterization and monitoring of ADAs with appropriate analytical tools.Join us & take away the strategies to minimize the risks of immunogenicity for your medicinal products.
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