As bioconjugation expands beyond conventional antibody-drug conjugates into increasingly complex modalities, integrated development and manufacturing capabilities are becoming increasingly important. In this webinar, Samsung Biologics will share its approach to supporting bioconjugation programs through integrated development, manufacturing, analytical, and formulation capabilities at a single site. The presentation will highlight experience across multiple conjugation technologies and modalities as well as case example demonstrating process scale-up and transfer from laboratory development to GMP manufacturing. Attendees will also gain insights into the analytical and CMC considerations that support bioconjugated products throughout development.Key TakeawaysIntegrated development and manufacturing for complex bioconjugatesProcess scale-up and transfer to GMP manufacturingAnalytical and CMC considerations across development
Speakers
Associate Director, Bioconjugation Development Team
Samsung Biologics
James Kim is Associate Director of the Bioconjugation Development Team at Samsung Biologics. He has led the development of platform analytical methods and processes for bioconjugated therapeutics. With extensive expertise in the development of complex biologics, he leads the development of platform analytical methods and processes for bioconjugated therapeutics. He holds a Ph.D. in biochemistry from the University of Washington. Prior to joining Samsung Biologics, he led analytical development programs for protein-based biologic candidates, including antibody-drug conjugates, at LigaChem Biosciences.
