Pregene has established a platform technology for lab-scale process development and pilot-scale production of autoimmune cell agents. The process ensures the viral transduction efficiency, cell expansion factor and critical quality attributes of cell agents, which is stable and allows controllable quality. The established cell preparation process has been used for the preparation of CAR-T cell agents for which the Company has obtained the approval letter for clinical trials, and the preparation process of CAR-T has been technically transferred to the partners and recognized by domestic and foreign partners.
By utilizing the process accumulation of autologous CAR-T cell drugs, the currently developing allogeneic CAR-NK cell preparation process has overcome critical technical difficulties such as efficient transduction of NK cell lentivirus, massive expansion and cryopreservation of NK cells. Now the expansion of single-batch NK and CAR-NK can reach more than thousands of times, resulting in achievable large-scale preparation of allogeneic universal off-the-shelf CAR-NK cell agents and significantly reducing the cost of immune cell agents.