The Critical Role of Forced Degradation in Method Development, Manufacturability & CMC Strategy
Summary: Forced degradation studies are essential to the successful development of monoclonal antibodies (mAbs), bispecifics, and other biologics. By simulating real-world stress conditions such as heat, light, oxidation, and agitation, these studies uncover degradation pathways early, helping drug developers define critical quality attributes (CQAs), optimize formulation strategies, and build robust Chemistry, Manufacturing, and Controls (CMC) frameworks. In this executive summary, explore how advanced analytical techniques such as SEC-MALS, SV-AUC, DLS, CE-SDS, and icIEF provide comprehensive insights into protein aggregation, fragmentation, and charge heterogeneity. Learn how integrating these insights into stability-indicating method development strengthens regulatory submissions and supports manufacturability from early development through commercialization.