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.
Watch this webinar to:
- 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