The Power of CE–MS in Biotherapeutics Characterization

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Characterization of biologics, especially mAbs, is a challenging task. To ensure safety, efficacy and potency of a therapeutic agent, biopharma companies must determine the heterogeneity of the structure as it progresses through cell culture, purification, and storage. Yet the presence of positively charged and negatively charged amino acids and negatively charged glycans (sialic acids) means that mAbs exist as multiple charged species. Understanding which amino acids or glycans are involved and their specific location within mAbs is of paramount importance.

Traditional ion exchange chromatography enables the separation of some charge variants, particularly those positioned on the surface of the protein. However, the better option for this task is microfluidic CE–MS (capillary electrophoresis - mass spectrometry) to analyze intact mAbs and assess the root cause of stressed mAbs. CE–MS provides a very powerful direct and generic tool for separation and identification of charge heterogeneity of mAbs.

Key Learning Objectives:

• Understand the important role of CE–MS in biotherapeutic characterization
• See what Zipchip is and how it works
• Review a case study at Transcenta that uses CE–MS for charge variant analysis

Who Should Attend:

• Scientists working in protein characterization labs for biotherapeutics
• Analytical scientists working in biopharmaceutical labs
• CDMO labs looking to optimize workflows and improve efficiency

Speakers

Liang Wang
Senior Account Manager, Life Sciences
908 Devices

Dr. Liang Wang has more than eight years of analytical and biochemistry experience with a special focusonmass spectrometry related topics. He received his PhD from Fudan University in China and served as aresearch associate at UNC Chapel Hill. With a CV that includes numerous publications and patents, Liang joined 908Devices as the science leader for APACregion.

Liming Shi
VP, Analytical Science, Quality Control, Product & Process Development
Transcenta Holding LTD

Liming Shi has 22 years of biologics experience with companies including Genentech, Amgen, Eli Lilly and Pfizer. While at Genentech he created the world’s first qPCR technology platform for virus removal testing in mAb purification processes. Liming joined Transcenta in 2019 as the company’s vice president in charge of analytical science, quality control, product and process development operations

Register Free: http://www.chromatographyonline.com/lcgc_w/CE-MS