Advanced Analytical Strategies for Biosimilar Characterization

This custom eBook examines how advanced analytical characterization is changing biosimilar development following the FDA's October 2025 draft guidance. It covers modern SEC separations for biosimilar antibodies, LC-MS and MAM workflows for protein characterization and attribute monitoring, and the role of multi-angle light scattering (MALS) in biosimilar approval. A closing Q&A with Matthew A. Lauber, PhD, of Waters Corporation, explores how integrating these complementary techniques builds a more complete, regulatory-ready picture of biosimilarity.