Manufacturing of genetically modified autologous T cells: key considerations for process development
Cell & Gene Therapy Insights 2019; 5(3), 351-358.
The spectacular advancement of chimeric antigen receptor (CAR) T cells has given birth to several new biotech companies with rapidly growing pipelines of T-cell therapy products targeting various tumor antigens. For all these new players entering the field of genetically modified T cells, the manufacturing capability becomes one of the critical factors for success. Whether developed at a contract manufacturing organization (CMO) or in-house, a thorough know how of the manufacturing process is central to successful delivery of quality products. Here, we present currently available options for major steps, important considerations during optimization and challenges of process development for manufacturing of genetically modified autologous T cells.