Trends in Cell and Gene Therapy: De-risking Platform and Product Development with Mass Spectrometry

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Cell and gene therapies have the potential to provide long-term therapeutic efficacy, but their development is both risky and cost intensive. Obtaining a better understanding of the specific structural attributes of vector proteins that influence clinical delivery and outcomes is essential for advancing both individual candidates and the platforms on which they are based.

Strategic application of advanced analytical techniques can help improve selection of candidates and guide development decisions, leading to a greater number of safer, more efficacious therapies successfully completing development and entering the market. High-resolution LC-MS based characterizations and quantification approaches as well as in vivo expression profiling are increasingly being applied to enable improved program understanding, controls and clinical outcomes assessment.

On June 25, 2020, the presenters discussed application of MS-based analyses of gene therapy products, specifically AAV-based therapies, and their value for advancing and de-risking product development. LC-MS approaches for monitoring key HCPs and evaluating other viral product quality attributes concurrently, for example, to assess lot-to-lot comparability.

About the Presenters

Jennifer S. Chadwick, PhD

Dr. Chadwick is Vice President of Biologic Development at BioAnalytix. She is an expert in biologics development, with extensive experience in analytical characterization, stability and formulation applied to diverse biologic molecules and systems. Prior to joining BioAnalytix, Dr. Chadwick was a tenured Professor and Louise Byrd Graduate Educator in the Department of Pharmaceutical Chemistry at the University of Kansas. Her academic research focused on understanding molecular mechanisms of underlying instability of proteins and their stabilization by exogenous compounds. During her twelve years at KU, Prof. Chadwick also engaged in biologic drug development and collaborated and consulted with numerous pharma/biotech companies to investigate stability problems and related formulations in therapeutic proteins. She has published approximately 70 peer-reviewed publications, 13 patents and four book chapters, demonstrating her expertise and deep understanding of biologics and drug development.

Chen Li, PhD

Dr. Li is Director of Analytic Sciences at BioAnalytix. She mainly focuses on applying advanced mass spectrometry-based approaches to help the development of complex biologic drugs. Her work has been published in over 10 peer-reviewed publications and industry papers. Prior to joining BioAnalytix, she worked at ImmunoGen for antibody-drug conjugates development. Dr. Li received her PhD from Northeastern University at the Barnett Institute, where she developed LC-MS methods for biosimilar comparison and transmembrane protein characterization.

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