Article | May 2, 2022

Tips To Improve Size-Exclusion Chromatography For mAbs And ADCs

By Cory E. Muraco, Global Franchise Manager, Liquid Chromatography Technology and Wayne K. Way, Ph.D., Pharma Analysis & QC Strategy, MilliporeSigma

research data biologics iStock-1193999867

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.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Pharmaceutical Online