Determining Critical Quality Attributes for Adeno-Associated Virus Analysis

This poster introduces a novel prototype size exclusion chromatography (SEC) column designed to enhance the analytical capabilities crucial for the development and analysis of Adeno-Associated Viruses (AAVs) in gene and cell therapy. Limitations of various non-LC analytical methods are reviewed with highlights given to complementary and/or orthogonal techniques during early development phases. The analytical potential of LC methods, particularly SEC, is emphasized, focusing on Critical Quality-Attributes outlined by USP guidelines. Herein, we review how a prototype SEC column addresses specific challenges related to the comprehensive analysis of AAVs, covering aspects such as capsid purity, aggregation, free DNA, and genome titer.