Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing

By Kyle Reder, Segment Strategy Manager for Cell & Gene Therapy, and Dr. Sarah Sheridan, Technical Consultant, MilliporeSigma

Over the last decade, there has been a significant amount of growth in the cell and gene therapy (CGT) market, with over 700 assets in 1,195 active clinical trials and 959 programs at a discovery or preclinical stage.¹ This strong clinical pipeline, which has made CGT the fastest growing segment of the regenerative medicines market, is due to a number of factors.² In addition to a rising number of patients struggling with cancer and chronic diseases, there has also been increased funding and investments for CGTs as well as a favorable regulatory environment that has seen a number of approvals for these products in 2020.³

Despite potential of these novel treatments and their fast rise in the industry, manufacturers face several challenges when utilizing compendial testing methods for sterility, mycoplasma, and replication competent lentivirus (RCL) of CGTs. The development of rapid methods that can provide comparable results while meeting the need for high-throughput performance offers significant promise for addressing these issues within this rapidly growing area of the market.