Richard Ludwig

Company: Bristol Myers Squibb

Job title: Director, Analytical Development & Attribute Sciences

Seminars:

Understanding the Approaches to Extended Characterization; Evaluating the Regulatory Needs & Expectations 11:30 am

Identifying key attributes for extended characterization of ADCs, such as drugto-antibody ratio, conjugate stability, and impurity profiles, and aligning them with regulatory expectations Evaluating advanced analytical methods (e.g., mass spectrometry, bioassays) that improve the accuracy of structural and functional characterization to meet detailed regulatory requirements Reviewing global regulatory expectations for data depth in ADC characterization,…Read more

day: Day One