Alexander E. Yarawsky, Valeria Zai-Rose, Hazel M. Cunningham, John W. Burgner 2nd, Michael T. DeLion, Lake N. Paul. AAV analysis by sedimentation velocity analytical ultracentrifugation: beyond empty and full capsids. European Biophysics Journal, volume 52, pages 353–366, (2023). DOI: Click Here 

About This Research

The surge in AAV-based gene therapies has elevated the importance of comprehensive impurity profiling beyond simple empty/full capsid ratios. At BioAnalysis, we recognize that regulatory compliance requires detecting and quantifying all species that could trigger immunotoxicity, including free DNA, partially filled capsids, and aggregates. This research showcases how sedimentation velocity analytical ultracentrifugation (SV-AUC) provides unmatched resolution for characterizing these critical quality attributes directly in formulation buffers, surpassing traditional chromatographic methods in both sensitivity and accuracy.

Why This Matters

As the authors emphasize, “a significant amount of empty and partial/intermediate AAV molecules may exist,” highlighting the complexity of AAV preparations beyond simple empty/full ratios. This comprehensive characterization approach aligns with FDA guidance on limiting immunogenic impurities and exemplifies why BioAnalysis has invested in cGMP-qualified SV-AUC capabilities for gene therapy analytics.