Characterisation Of AAV Product-related Impurities

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.

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