Breaking viral vector bioanalysis barriers with centrifugal force

Abstract

Advances in viral vector gene delivery systems, particularly adeno-associated virus (AAV) and lentivirus (LV), have accelerated the development of new cell and gene therapies. Regulatory programs for accelerated review have added to the demand for the manufacture of viral vectors, exceeding capacity and creating backlogs. Improvements in analysis speed, accuracy, precision, and dynamic range are potential targets for accelerating production timelines. Plate-based enzyme-linked immunosorbent assays (ELISAs), commonly used in analysis of viral vector titer, purity, and potency, have laborious and time-consuming manual processing drawbacks as well as long processing times and poor precision. A novel automated microfluidic, compact disc (CD)-based immunoassay format that uses centrifugal force to precisely control the flow of sample and reagents has been notably effective in accelerating bioanalysis of antibody-based therapeutics with high-precision results. One-hour assay run times and wide dynamic ranges accelerate workflows, and 10 µL sample requirements minimizes consumption of limited production material. These dramatic immunoassay improvements are expected to alleviate the analytical delays in viral vector manufacturing.