SEC-MALS as a Platform and Release Assay for AAV Development and Production

As one of the most promising in-vivo gene delivery vectors, adeno-associated virus (AAV) has been widely used in various gene therapy products. In order to ensure the safety and efficacy of these AAV-based gene therapy products, it is crucial to understand and measure their critical quality attributes (CQAs) throughout the development cycle. In this podcast, we will discuss how to apply a well-established bio-therapeutics characterization tool, SEC-MALS (size-exclusion chromatography combined with multi-angle light scattering and other online concentration detectors), for quantifying AAV CQAs. This SEC-MALS method has been recognized and demonstrated as a robust, sensitive, and automated assay for AAV development platform and production release testing.