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Improving the therapeutic quality and consistency of cell and gene therapies requires the adoption of enhanced Critical Quality Attributes (CQAs) throughout the development and manufacturing processes. A novel nanoneedle platform provides crucial insights by precisely quantifying AAV subpopulations—empty, partial, full, and overfilled capsids—at the molecular level, overcoming key limitations of traditional methods. This deeper characterization is essential for accurate dosing, improved patient safety, and manufacturing efficiency.
This GEN webinar will feature three presentations from leading experts in cell and gene therapy, from academia, biopharma, and biotech, who will share their vision for comprehensive gene therapy characterization across vector development, manufacturing, potency testing, and biodistribution. The session will also highlight the potential of the nanoneedle technology to advance and standardize the field.
Enhanced AAV Critical Quality Attributes (CQAs) Streamline the Transition from AAV Vector Design to Comprehensive Gene Therapy QC Characterization
Guangping Gao, PhD, Professor & Chair, Department of Genetic and Cellular Medicine Professor, Microbiology; Penelope Booth Rockwell Professor in Biomedical Research; Director, Horae Gene Therapy Center and Viral Vector Core; Director, Li Weibo Institute for Rare Diseases Research; UMass Chan Medical School
Working the 1-in-1000 Problem: Shedding Light on AAV Product Quality and Manufacturing Performance with Nanoneedle Technology
Daniel Hurwit, Senior Principal Scientist, Bristol Myers Squibb
Rethinking the Potency Assurance Matrix and Integration of Novel Analytical Technologies into Quality Control Patrick Starremans, PhD, Head of Analytical Sciences, Solid Biosciences
A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists.
Produced with support from:
