Downstream Processing 2023

Considerations for affinity capture in an AAV platform downstream process

Cell & Gene Therapy Insights 2023; 9(9), 1387–1396

DOI: 10.18609/cgti.2023.180

Published: 22 November 2023
Innovator Insight
Jett Appel

In the rapidly evolving field of gene therapy, AAV vectors have shown increasing therapeutic promise. In recent years, a variety of different therapies using various AAV serotypes have received regulatory approval, and hundreds more are in clinical trials. From discovery to the clinic, as the quest to produce new, high-quality AAV molecules intensifies, an efficient and scalable platform purification process for multiple AAV serotypes is advantageous for both drug developers and CDMOs. This article explores the considerations when evaluating a platform affinity capture step for the purification of AAV vectors. Specificity, binding capacity, purity, yield, scalability, and reusability parameters will be addressed.