Characterization and release testing for AAV therapies: empty/partial/full capsid analysis and impact on potency

Karen Doucette is a Scientific Advisor at Charles River Laboratories supporting the Cell & Gene Therapy portfolio. Positioned within the Global Manufacturing division, Karen serves as a CGT Navigator and plays a critical role in partnering with clients to map the development journey from discovery through commercial manufacturing. With a focus on aligning phase-appropriate CMC with preclinical and clinical activities, Karen works cross-functionally across all Charles River divisions to integrate CDMO products and services with other divisions including Discovery, Safety Assessment, Testing, and RMS. She brings a deep technical understanding of the drug development lifecycle and the requirements for transferring novel advanced therapy technologies out of academic research and into pharmaceutical development.

Karen has over 20 years of experience with biopharmaceutical CROs and CDMOs, spanning pre-clinical and clinical research, development and manufacturing. She received her Bachelor’s degree in Animal Science from the University of Delaware and completed her MBA at Goldey-Beacom College.

Flora Vass is a Research Associate in the Biophysical Characterization group based in Shrewsbury, Massachusetts. Flo joined CRL in 2020, with a primary focus on the SV-AUC analysis of AAV gene therapy products. At CRL, Flo supports the feasibility and optimization of client methods, works on validation projects to develop client assays, and performs routine GMP lot release testing. Prior to joining CRL, Flo worked in the UK as a Forensic Scientist, specializing in the analysis of controlled drug substances.

Karl Bertram is Founder and Managing Director of ATEM Structural Discovery. He holds a PhD in biochemistry and structural biology and has an extensive scientific background in advanced cryo-EM technology. Karl obtained his PhD at the Max Planck Institute for Biophysical Chemistry in Göttingen, Germany, where he significantly contributed towards solving the first high-resolution 3D structures of the human spliceosome. During his earlier academic career, he obtained a Master of Science degree in Biochemistry from the Ludwig Maximilian University (LMU) Munich and spent time for a research visit at the Rockefeller University in New York City.