Viral Safety in AAV Production: How Affinity Chromatography Effectively Contributes

Adeno-associated vectors (AAV) have become the workhorse for gene therapy delivery over the last two decades. With the constantly growing number of clinical trials, the demand for vectors has increased significantly and the need for reliable and scalable manufacturing solutions has emerged. Within this context, the introduction of POROS™ CaptureSelect™ AAV immunoaffinity resins for the capture and purification of AAV vectors resulted in significant improvement by reducing the number of purification steps, maximizing productivity, and offering scalability and process consistency at commercial scale.

Concomitantly, the regulatory environment has expanded in parallel to the use of AAV. The ongoing revision of the ICH Q5A guidance—relative to the viral safety of biotechnology products derived from cell lines of human or animal origin—is expected to require demonstration of viral clearance as an integral part of any new drug applications, including gene therapy with AAV vectors.

In this GEN webinar, our presenters will demonstrate the efficiency of POROS CaptureSelect AAVX affinity chromatography as an effective viral clearance removal step in the downstream manufacturing of AAV for gene therapy and vaccine applications.

LEARNING POINTS:

• Understand the benefits of affinity chromatography in AAV production.

• Learn about viral clearance and how affinity chromatography resins can contribute to the overall viral clearance in AAV manufacturing.

A live Q&A session followed the presentations, offering you a chance to pose questions to our expert panelists.

Webinar produced with support from: