Achieving robust and scalable AAV empty/full capsid separation for gene therapy

Cell & Gene Therapy Insights 2025; 11(2), 151–161

DOI: 10.18609/cgti.2025.019

Published: 26 February
Innovator Insight
Julio Huato, Mark Schofield

Efficiently separating empty and full capsids to ensure product purity and vector safety remains a crucial challenge for the adeno-associated virus (AAV)-based gene therapy field. This article highlights the importance of efficient separation techniques, such as ion exchange chromatography, and the development of a two-step elution strategy. A case study is outlined that highlights batch-to-batch reproducibility and fast flow rates suitable for large-scale manufacturing.