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Victoria C. Cotham, Shunhai Wang, Ning Li
Regeneron Pharmaceuticals, Inc.
Adeno-associated viruses (AAVs) represent a leading platform for therapeutic gene delivery, with multiple FDA approved AAV-based therapies currently on the market and many more candidates undergoing clinical trials. The fast-paced development of this class of therapeutics places a high demand on robust analytical methods capable of efficiently monitoring product quality to ensure safety and efficacy, as well as to support manufacturing and process optimization. In this webinar, the development and application of an online native MS approach that provides rapid and quantitative assessment of empty, partial, and full capsids will be discussed. This method can be universally applied to different AAV serotypes and is highly sensitive to capsid detection making it amenable to low titer and in-process samples, as well as for monitoring relative changes in capsid content ratios under stressed conditions.