Comparing Methods that Determine Empty-Full Ratio of AAV Capsids

The relative abundance of empty and full AAV capsids in gene therapy vector preparations is a critical quality attribute. A variety of methods are available to perform these measurements including SEC-MALS, which combines separation by size-exclusion chromatography with detection by multi-angle light scattering, UV/Vis, and differential refractometry. However, there are relatively few reports that compare these methods.

This webinar compares the outcomes of numerous orthogonal characterization methods on a single vector preparation. We find that SEC-MALS not only provides favorable performance for quality control and product development applications, but that it is uniquely situated to be established as a platform method for the semi-quantitative measurement of empty/full ratios across AAV serotypes, transgenes, and manufacturing processes.

Key Learning Objectives:

• How SEC-MALS quantifies empty and full AAVs, as well as other attributes
• Are empty/full readouts from different assays comparable?
• Other light scattering techniques that quantify AAVs

Who Should Attend:

• CMC teams supporting AAV-based therapies
• Scientists involved in AAV characterization, analytical method development, process development, and quality control
• Lab managers that need to select and support an optimal set of AAV characterization methods

Presenter: Margaret Butko (Associate Director, Protein Analytical Characterization at Adverum)

Presenter: Prithwijit Sarkar (Regional Manager, Northern California, Wyatt Technology Corporation)

Presenter: Kelly McSweeney (Contributing Editor, C&EN Media Group)