Unveiling the critical pathways in AAV potency evaluation and future trends in gene therapy

In this expert roundtable, three experienced professionals from the gene therapy industry discuss the critical evaluation of AAV potency and its impact on the industry’s advancements. The panelists share insights on CMC evaluation, varied assay development based on therapy mechanisms, and platform evolution.

David Rangel, Senior Director of Analytical Development, has worked for Catalent, Washington, DC, USA for 10 years where he is responsible for development of Catalent platform and client specific analytical methods for gene therapy products. Before this, David led a physio-chemical characterization team of viral particle analytics for a government-sponsored filovirus vaccine development program at Paragon Bioservices.

Guangping Gao is a Professor and Director of Horae Gene Therapy Center and Viral Vector Core at the University of Massachusetts Chan Medical School, Worcester, MA, USA. Guangping primarily focuses on viral vector discovery and was involved in the discovery and characterization of new family AAV serotypes for gene therapy.

Nathalie Clement, Vice President of Vector Development for Translational Gene Therapies at Siren Biotechnology, San Francisco, CA, USA has over 25 years of experience in the gene therapy field with leading expertise in AAV viral vector manufacturing. Nathalie has led AAV process development and manufacturing for R&D POC, IND-enabling toxicology, and IND studies and currently leads CMC operations to bring clinical candidates to patients.

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