Mass Spectrometry – an Essential Tool for Characterization of Monoclonal Antibodies during Development

Monoclonal antibodies (mAbs) represent a big portion of therapeutic proteins. Mass spectrometry (MS) coupled with modern separation technologies has become an essential tool in characterization of mAbs within the Quality by Design (QbD) paradigm during development. This Webinar will discuss the application of MS analysis in clone selection, optimization of fermentation conditions, development of purification and formulation. Specifically, simultaneously detect and monitor variants due to incomplete leader sequence processing, accurately determine afucosylation level of N-glycosylation, characterize host cell proteins (HCPs), identify degradation pathways and critical quality attributes (CQAs) will be discussed.
 
Dr. Wei Xu is a principal scientist in analytical method development at Merck Research Laboratories. He is an expert in characterization of therapeutic proteins using analytical methods based on mass spectrometry, UPLC and CE.  Dr. Xu has 10+ years’ experience in characterization of mAbs and other proteins while working in Merck, Regeneron and legacy Schering-Plough. Prior to that, he worked on the characterization of cannabinoid receptor 1 (CB1 receptor).  Dr. Xu received his Ph.D in pharmaceutical Sciences and MS in Statistics from the University of Connecticut.
 
Sponsored by Waters Corporation
 

Waters Corporation creates business advantages for laboratory-dependent organizations by delivering scientific innovation to enable customers to make significant advancements. Waters helps customers make profound discoveries, optimize laboratory operations, deliver product performance, and ensure regulatory compliance with a connected portfolio of separations and analytical science, laboratory informatics, mass spectrometry, as well as thermal analysis.
Henry Shion
Henry Shion is a principal scientist working in the global marketing division of Waters Corp. He has more than 15 years hands-on Mass Spectrometry (LC-MS, GC-MS, MALDI/MALDI imaging) experience for both biopharmaceutical and small molecule applications. He is currently focused on developing LC-MS based analytical solutions for routine characterization and quantification of biotherapeutics, such as monoclonal antibodies, biosimilars and antibody-drug conjugates (ADCs). Henry has published more than 15 peer reviewed papers in various scientific subjects. He obtained his Ph.D. from Drexel University in 1997 and carried out a postdoc training at University of Illinois’ College of Pharmacy (under Dr. Richard van Breemen) before joining Waters in late 1998.