Understanding the Approaches to Extended Characterization; Evaluating the Regulatory Needs & Expectations
Time: 11:30 am
day: Day One
Details:
- 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, focusing on aligning extended characterization data with compliance standards for safety and efficacy
