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examines how advanced analytical characterization is changing biosimilar development following the FDA's October 2025 draft guidance.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.
This week, Chromatography Online’s coverage included LCGC Lifetime Achievement and Emerging Leader award winners, chiral gas chromatography (GC), and artificial intelligence (AI)-driven liquid chromatography (LC) methods.
Nano-liquid chromatography-high-resolution tandem mass spectrometry (nano-LC-HRMS/MS) reveals saliva protein shifts before and after multiple sclerosis therapy.