SC 4 - ADC “Developability”: Critical Quality Attributes Inform Formulation and Process Development
ADCs have unique critical quality attributes (CQAs) that are affected by the nature of the component parts: the antibody, the linker and the toxin. The CQAs are also strongly affected by the formulation, the process parameters, and the storage conditions. Effective formulation and process development strategies are based upon a molecular understanding of ADC CQAs: aggregates, charge variants, drug antibody ratio, conjugation site, free drug. Development of these complex molecules requires an array of analytical and biophysical techniques that are used to identify attributes that could have a clinical impact.
In this short course, the attendee will learn:
- Characterization tools to inform rational ADC development
- Intrinsic molecular attributes: Consideration of the mAb,
linker and payload
- Degradation pathways of ADCs
- Extrinsic factors that affect CQAs: Formulation and process design
Janet Wolfe, Ph.D., President & CEO, Wolfe Laboratories
Janet Wolfe is president and founder of Wolfe Laboratories, Inc., a biopharmaceutical development services company located in Watertown, Massachusetts. Dr. Wolfe’s scientific and business career has focused on the intersection of the critical path activities in CMC, DMPK, preclinical and clinical development. Hundreds of biopharmaceutical companies seek the expertise of Wolfe Laboratories’ scientific team to facilitate the translation of their compounds from late-stage discovery into clinical studies. The company designs and executes development programs for small molecules, biologics and antibody drug conjugates across therapeutic areas such as CNS, cardiovascular, metabolic diseases, immunology and oncology. Wolfe Laboratories has contributed to the advancement of molecules through all stages of development and commercialization. Prior to starting Wolfe Laboratories in 1999, Dr. Wolfe was on the faculty of the Department of Pharmaceutical Sciences at the University of Tennessee, Memphis, which followed her postdoctoral fellowship in the Warren G. Magnuson Clinical Center Pharmacy at the National Institutes of Health. Dr. Wolfe is the author of numerous articles and presentations, and she has mentored undergraduate and graduate students and postdoctoral fellows over the course of her career. Dr. Wolfe received her Bachelor of Science from the University of Sciences in Philadelphia and doctorate in pharmaceutical chemistry from the University of Kansas.
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