De-Risk Your mAb Programs with Orthogonal Stability Studies
Abstract: Characterizing molecular stability early is critical to advancing biologics through development and into the clinic. This case study highlights how Catalent supported a sponsor with time-sensitive forced degradation studies to evaluate an IgG1 monoclonal antibody. By applying complementary analytical tools, including SEC-MALS, SV-AUC, DLS, CE-SDS, and icIEF, Catalent identified key degradation mechanisms under thermal, chemical, and mechanical stress. These insights enabled the team to refine formulation direction, map out stability-indicating methods, and strengthen the CMC package ahead of regulatory submission. Discover how this data-driven approach helped the client mitigate risk, reduce delays, and build confidence in long-term product viability.