Critical Role of Forced Degradation in Method Development of mAbs
Summary: Forced degradation studies are crucial for developing recombinant monoclonal antibody therapeutics, aiding in everything from early manufacturability checks to comparability assessments before and after marketing approval. For this study, an IgG1 antibody was subjected to numerous forced degradation pathways and analyzed by SV-AUC (Sedimentation Velocity-Analytical Ultracentrifugation), SEC-MALS (Size-exclusion chromatography multi-angle light scattering), and DLS (Dynamic Light Scattering) to determine sedimentation coefficient, percent distribution, molecular weight, polydispersity, and overall particle size analysis. The individual and orthogonal results from the methods will be presented and discussed in regard to the conditions the molecule was subjected to.