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Session 6C: Antibody-Drug Conjugates (ADC)
Session Chair(s)
T. Venkateshwaran, PhD
Vice President and Global Head CMC Biologics, Medical Devices and Comb
Merck & Co., Inc., United States
Sarah Pope Miksinski, PhD
Executive Director, CMC Regulatory Affairs
Gilead Sciences, United States
The goal of this session is to discuss the current status of the various control systems for Antibody-drug conjugates (ADCs) and some of the typical challenges that are encountered during their development and commercialization. ADCs, monoclonal antibodies (MAbs) coupled to cytotoxic agents, utilize the specificity of a monoclonal antibody to deliver a cytotoxic drug to tumor cells. Since an ADC product is a mixture of conjugated species, appropriate assays are key to characterize and release ADC products as well as identifying potential critical quality attributes (CQAs) for the conjugates, including those for the antibody, the cytotoxic agent, and the linker.
Speaker(s)
Antibody Drug Conjugates – Current Status of Regulations
Debasis Ghosh
FDA, United States
Office of New Drug Quality Assessment, CDER
Antibody Drug Conjugates – Current Status of Regulations
Marjorie A. Shapiro, PhD
FDA, United States
Chief, Laboratory of Molecular and Developmental Immunology, OBP, CDER
Analytical Characterization and Control Strategies for Antibody Drug Conjugates
Heyi Li, PhD
Analytical R&D, BioTx PS; Pfizer, Inc., United States
Senior Principal Scientist
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