The development and approval of biosimilar monoclonal antibody (mAb) therapeutics offers a promising path to reducing healthcare costs and increasing patient access to life-saving treatments. However, demonstrating biosimilarity requires rigorous analytical characterization of both the candidate and reference products. This application note highlights how size-exclusion chromatography coupled with multi-angle light scattering (SECMALS) provides a simple, robust, fit-for-purpose workflow to assess critical quality attributes (CQAs), such as purity, aggregation, fragmentation, and self-association behavior.

Download this report to explore how SEC-MALS enables comprehensive biosimilarity assessment of monoclonal antibody therapeutics, including purity, aggregation, fragmentation, and self-association analysis.