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Webcast | Virtual

Event Title
FDA Grand Rounds – Antibody Glycosylation Insights for High-Quality Biotherapeutics
January 22, 2026

Date:
January 22, 2026
Time:
12:00 p.m. - 1:00 p.m. ET

Webcast Recording

Recording

Speaker 

Baolin Zhang, PhD

Baolin Zhang, PhD
Senior Biomedical Research and Biomedical Product Assessment Service Expert 
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration

About the Speaker

Dr. Baolin Zhang has 25 years of experience in regulatory affairs at FDA, specializing in CMC (Chemistry, Manufacturing, and Controls) and product quality assessment for biologics and biosimilars. As a distinguished SBRBPAS Expert (Senior Biomedical Research and Biomedical Product Assessment Service Expert) at FDA’s Center for Drug Evaluation and Research, he leads regulatory reviews for numerous Investigational New Drug Applications (INDs) and Biologic License Applications (BLAs) and directs translational research programs.

Dr. Zhang is recognized for his contributions to biotherapeutic characterization, bioassays, and biomarkers, with over 100 publications, 200 invited presentations, and more than 20 major awards, including the FDA Scientific Achievement Award and the AAPS High Impact Article Award.

Before joining FDA, he was an Associate Professor at Nanjing University, Deputy Director at the Beijing Center for Biologics Research & Development, and Senior Scientist at the University of Tennessee Health Science Center. He holds a Ph.D. in Chemistry from Peking University, and M.S. and B.S. degrees in Chemistry from Lanzhou University.

About the Presentation

This lecture will examine how antibody Fc glycosylation influences product quality, potency, and clinical performance, highlighting common glycan features in FDA-approved antibodies, strategies for glycosylation control, and the use of a tailored lectin microarray for characterization. It will also address the gap between in vitro Fc-mediated effector functions and clinical evidence, emphasizing a mechanism-driven, totality-of-evidence approach to quality and regulatory assessment.

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