Advanced Therapies 2025

Listen to our presentation

Speaker: Andreja Gramc Livk, Head of Process Analytics, Sartorius BIA Separations

Date and Time: Tuesday, March 18, 2025 at 1:20 PM (Gene Therapy Stage)

Title: Comprehensive Analytics for Monitoring AAV Capsid Production

Abstract:

This presentation will discuss an anion-exchange (AEX) analytical method for characterizing and assessing the quality of AAV capsids. This one-dimensional analytical method offers deep insights into AAV heterogeneity, providing high-resolution separation of full capsids across various sample matrices during the final stages of downstream processes (DSP).

Additionally, a complementary chromatographic method has been developed to determine the percentage of AAV full capsids in upstream processes (USPs). This method utilizes a two-dimensional liquid chromatography system that directly assesses full AAV capsids from the clarified harvest. It offers rapid analysis times and achieves baseline separation of empty and full capsids in complex harvest samples.

In conclusion, we will explore through case studies how this combined analytical approach boosts AAV production, elevates AAV quality assurance, and ensures regulatory compliance.

About the event

The Advanced Therapies Congress unites speakers from the entire cell and gene therapy value chain, including pharma, biotech, startups, researchers, clinicians, academics, HTAs, payers, and regulators. With 10 content tracks over 2 days and 100 leading solution providers, it meets your needs at all development stages.

Location: London, UK