By Cory E. Muraco, Global Franchise Manager, Liquid Chromatography Technology and Wayne K. Way, Ph.D., Pharma Analysis & QC Strategy, MilliporeSigma
Product characterization is the essential foundation for successful biological drug development. Understanding the chemistry, structure, and biological activities ensures the quality control will measure critical product safety, purity, and potency attributes, as per ICH Q6B. Furthermore, in May 2019, the Food and Drug Administration (FDA) published guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality- Related Considerations. In the guidance, aggregation as a critical quality attribute is specifically mentioned. In this article, we will explore tips to improving the method of Size Exclusion Chromatography (SEC) which is often used to measure monomer/aggregate and fragment content of mAbs and ADCs.