AAV downstream processing for industrial scale production - moving towards commercial manufacturing
In this presentation we discuss the benefits of implementing affinity chromatography in the downstream purification of viral vectors. The utilization of POROS™ CaptureSelect™ AAV affinity resins results in a significant improvement to the downstream process of AAV. By reducing the number of purification steps, maximizing productivity, offering scalability and process consistency, these resins can be used for clinical and commercial manufacturing.In conjunction, the importance of understanding regulatory requirements such as process and product impurity clearance and viral clearance are discussed and results of a viral clearance study are shown. This study demonstrates that the POROS™ CaptureSelect™ AAVX affinity resin could serve as an effective viral clearance removal step in the downstream manufacturing of these vectors.