Viral contamination is a risk for all biotechnology products. Establishing robust viral removal/inactivation steps mitigates the risk of adventitious and endogenous viral contamination and is essential for ensuring the safety of gene therapy products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses.
In this study, we focused on the initial development process of the retroviral-retentive Viresolve® NFR filter. The loading capacity and AAV vector recovery from the Viresolve® NFR filter was determined. In order to evaluate the efficacy of the Viresolve® NFR filter for removal of large viruses from AGTC’s AAV vectors, a preliminary viral clearance study was performed in the MilliporeSigma/Merck Virology R&D lab. Table 1 describes some of the key characteristics of the virus panel.