A case study on streamlining AAV titer determination using variable pathlength technology

Abstract

Today, one of the primary challenges in manufacturing recombinant adeno-associated virus (rAAV) of consistent quality remains the fact that current analytical tools are insufficient to meet all needs. This is due to their high variability (CV 20–40%), low sample throughput, and long turnaround times. Furthermore, process development can be time-consuming, especially in that many development cycles are required to achieve robust and consistent comparability between development lots. Variable pathlength technology (VPT) provides a new method for AAV titer determination using real-time monitoring, which eliminates the dependency on off-line testing and associated variability caused by sample manipulation. In this article, we will demonstrate how at-line process controls, using VPT, can offer quick and direct total viral vector analysis during development to enhance throughput and improve decision-making. The implementation of the SoloVPE System and FlowVPX System technology for AAV viral titer concentration will be explored.