With over 650 clinical trials reported, and with the recent approval of 3 cell and gene therapy products in the US, there is no doubt that cell and gene therapy is booming and shows the potential to revolutionize the future of medicine. Viral vector systems are by far the most widely used method to deliver therapeutic genes because of their high transduction efficiencies. A major challenge for the industry today is to produce enough high quality, functional virus to meet market demand. During production, viruses need to be recovered from large volumes of harvest cell culture fluid and it is vital to generate products of high titer, high potency and high purity to achieve the required therapeutic effect. One of the challenges in downstream processing is lack of scalable and efficient purification processes.<br/> <br/>The objective of this work was to investigate various depth and membrane filters as an efficient clarification step to separate viral vectors from host cells, cell debris and many impurities, including insoluble precipitants, aggregates and other materials found in typical viral vector cell culture. The clarification step needs to combine high capacity for impurity removal, high product yield, ease of scale-up and to maximally protect any further downstream operations, making the overall process more efficient, scalable and economical. In this work we show the steps taken to determine an optimal clarification solution for viral vector processes.<br/>

Optimizing the clarification process for viral vectors feed streams for use in gene therapy

2019 Spring National Meeting

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.