Real-Time Monitoring of AAV CQAs in a Chromatographic Polishing Step
Presented by: F. Michael Haller, Ph.D., Lonza Biologics, and Dan Some, Ph.D., Waters | Wyatt Technology
Presented Live: April 9, 2024
Downstream purification and enrichment of full capsids for AAV-based gene therapy products, along with aggregate removal, is typically accomplished by ion-exchange chromatography (IEX). Development of this process usually requires sending multiple fractions for offline analysis for each iteration of process conditions, creating a bottleneck that holds back time-to-market and burdens both the development and analytical teams.
Real-time multi-angle light scattering (RT-MALS) is a process analytical technique that quantifies biophysical attributes of AAVs including Vg/Cp, titer and aggregation. RT-MALS provides immediate, high-density feedback on critical quality attributes (CQAs) during the chromatography run, eliminating burdensome offline analyses, and enables optimized control over the collection of purified product. This webcast will present RT-MALS basics and case studies for accelerated AAV process development in a CDMO.