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Abstract
Evaluating critical quality attributes (CQAs) is essential in developing therapeutic monoclonal antibodies (mAbs). CQAs, such as attributes affecting target binding or Fc receptor engagement, directly influence drug safety and efficacy. In this webinar, we introduce two innovative techniques for assessing key modifications in mAb drug candidates: (1) enrichment based on target-affinity and (2) affinity-resolved size exclusion chromatography coupled with native mass spectrometry (AR-SEC-MS). We will discuss the development of these methods and their applications in studying the relationship between mAb attributes and functions.