Plasmid, vectors, and cell production
Vein-to-vein fully-closed system
CAR-T cell manufacturing is a critical component of our clinical development and future commercialization, as CAR-T cell therapies are complex, and in the case of autologous therapies, highly personalized. We control our manufacturing through our two GMP compliant manufacturing facilities in Suzhou and Shanghai, which will enable us to be self-sufficient in the production of CAR-T cells for clinical development and early-stage commercialization.
Our Suzhou and Shanghai manufacturing facilities established fully-closed production capabilities, designed to produce FasTCAR product candidates while reducing contamination risks and optimizing cost-efficiency. With this fully-closed design, we are able to operate multiple systems in one manufacturing cleanroom at the same time, with each system producing CAR-T cells for an individual patient. This fully-closed system is designed to reduce reagent consumable costs, labor costs, workshop equipment operations and depreciation. We believe these advantages, coupled with our ability to achieve next-day manufacturing for autologous CAR-T cells in one production shift, allow us to substantially reduce manufacturing cost, improve productivity and scale up our production in a cost-efficient manner.
Features
- Customized closed system
- Minimal manipulation
- Rapid genetic modification
- Minimized risk of contamination
Suzhou GMP facility
- 66,000 sq. ft. standalone manufacturing facility designed by a European company with rich experience in cell gene therapy manufacturing
- 21,500 sq. ft. GMP clean area (5 functional areas)
- 7.9 acres of perspective land to build commercial plant
