Method development for rapid adventitious virus detection during cell biomanufacturing
Ensuring viral safety during cell therapy product manufacturing is important for patients' wellbeing, but current in-vivo and in-vitro cell culture for infectivity testing are often insufficiently sensitive time consuming. To overcome this limitation, we developed a novel workflow called CCoNS-seq. The newly developed workflow leverages pre-lysis cell depletion, membrane filter-based virus concentration, cell-free nucleic acid digestion and agnostic amplification techniques to achieve a high sensitivity for adventitious virus detection. Our study aims to answer the critical question how sensitive is the CCoNS-seq workflow for accurate contaminant virus identification in the presence of elevated levels of cellular background? In this study, we demonstrate the CCoNS-seq's potential as a useful method for ensuring viral safety during cell biomanufacturing. We achieve that by evaluating the novel workflows performance against a reference or baseline method.