Real-Time Monitoring of AAV CQAs in a Chromatographic Polishing Step

BPI Contributor

April 10, 2024

1 Hr View

Date: Apr 9, 2024

Duration: 1 Hr

This webcast features: F. Michael Haller, PhD, Principal Scientist, Lonza Biologics & Dan Some, PhD, Senior Principal Scientist, Waters | Wyatt Technology.

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.

Key Takeaways:

  • The fundamentals of MALS-based analysis of AAV CQAs.

  • How RT-MALS integrates in-line and on-line with downstream unit operations.

  • The benefits of RT-MALS for rapid development of an IEX AAV enrichment process.

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