Characterisation of AAV-based Gene Therapy Product-related Impurities Using SV-AUC and Mass Photometry

Poster Authors:

Magdalena Pacewicz, Lauren Tomlinson, Tayla MacDonald, Kirsty McManus, Paul Getty, Michael Walker

Pharmaron Gene Therapy l Estuary Commerce Park, Speke, Liverpool, L24 8RB, UK

Since the first approved AAV product, Glybera in 2012, interest has rapidly increased. One challenge for AAV has been product quality, as product-related impurities, such as empty, partially filled, and overfilled vector capsids can impact safety and efficacy of AAV-based therapeutics. Characterization of AAVs requires reliable quantification of these impurities and plays a crucial role in the AAV manufacturing process, enabling product quality monitoring.

The current gold standard for analysis of payload heterogeneity is sedimentation velocity analytical ultracentrifugation (SV-AUC).

This poster was presented at the 26th International Conference on Analytical Ultracentrifugation by Pharmaron’s Magdalena Pacewicz.

Pharmaron offers a wide variety of Gene Therapy Development Services from our state-of-the-art cGMP biomanufacturing facility in Liverpool, UK, which includes advanced analytical platforms, high-throughput process development equipment and purpose-designed viral and plasmid GMP manufacturing suites.