Removing Aggregates and Fragments of Recombinant IgG1: Evaluating a Process Change to Implement, Appropriate Chromatographic Media

摘要

High-molecular-weight (HMW) and low-molecular-weight (LMW) product variants are critical quality attributes (CQAs) for monoclonal antibodies (MAbs) because they can cause severe immunogenic responses in human recipients. Aggregation is a common problem that can compromise the quality, efficacy, and safety of therapeutic proteins. It can occur at different stages in a biomanufacturing process: during cell-culture-based production, downstream process purification, drug-substance formulation, and storage of bulk drug substances or formulated drug products. Hence, the removal and control of MAb aggregates and fragments are crucial in bioprocessing.