Aav downstream processing – are we ready for industrial scale gene therapy?

The field of gene therapy has made a major comeback over the last decade, resulting in a significant paradigm shift in medicine. With a handful of approved therapies approved available in Europe and US, and an extensively growing pipeline of clinical trials, it is evident that scalable production solutions are needed. Adeno-Associated Virus (AAV) has become the vector of choice in many therapies. Each production process for viral vectors has its own unique impediments and AAV is no exception. Recent advances in chromatography resin development for AAV, have demonstrated AAV purification can be scalable and used as a platform for the purification of a large variety of serotypes achieving high purity and high yield in a single step. Here we outline the benefits of implementing affinity chromatography in the downstream purification of viral vectors. The utilization of POROS™ CaptureSelect™ AAVX affinity resin results in a significant improvement to the downstream processing of AAV, by reducing the purification steps and maximizing productivity, offering scalability and processing consistency. In conjunction, results of a viral clearance study are shown, demonstrating the AAVX resin could serve as an effective viral clearance removal step in the downstream manufacturing of these vectors at industrial scale. [ABSTRACT FROM AUTHOR]