Size-exclusion chromatography with multi angle light scattering (SEC-MALS) for AAV characterisation.

A challenge for AAV manufacturing and process development is the ability to rapidly characterise quantity and quality for any serotype using at-line, in-line and off-line analytical techniques. Size-exclusion chromatography with multi angle light scattering (SEC-MALS) combines the power of light scattering technology with a size-based separation technique to provide information on molecular weight, size and quantity, with potential for use in-line or off-line. The Cell and Gene Therapy Catapult has developed and qualified an automated and high throughput SEC-MALS method with improved precision and comparable accuracy to orthogonal methods.