Cell Testing for Adventitious Viruses: A Game Changing Approach using High-Throughput Sequencing
The use of high-throughput sequencing (HTS) to identify viral contamination of biological products is extremely sensitive and provides a broad range of detection. PathoQuest has developed a new approach to differentiate inert versus active viral sequences to assist customers with de-risking the production process. This new method enables the ability to identify newly synthesized RNAs, an unequivocal sign of the presence of a transcriptionally active virus. This game-changing methodology can be used by biopharmaceutical companies to improve the sensitivity and specificity of testing for adventitious viruses and to reduce the overall time needed for viral testing, thus reducing the time required to achieve a marketable product. This new testing approach, which can be validated in line with GLP and GMP requirements, is applicable to cell banks, cell therapy drug products, vaccines, and raw materials and also has industrial application for virus inactivation testing and testing for the lack of replication-competent viruses in vector stocks.