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 GMP compliant manufacturing facility in Suzhou with high productivity. Hundreds of samples have been produced for our product candidates to be used with patients in the ongoing investigator-initiated and IND Phase 1&2 trials in China. In 2024, we’ve deepened the strategic cooperation with BioBAY in Suzhou to further enhance our production capacity of cell therapy drugs, ensuring the supplies for more clinical studies in China.
Our Suzhou manufacturing facility established fully-closed production capabilities, designed to produce FasTCAR product candidates while reducing contamination risks and optimizing cost-efficiency. We believe these advantages, coupled with our ability to achieve next-day manufacturing for autologous CAR-T cells, allow us to improve productivity and scale up our production in a cost-efficient manner. Beyond our capabilities in China, we have also expanded our manufacturing capabilities to the United States to enable a local supply of high-quality novel cell therapies, including through collaborations with contract development and manufacturing organizations in the U.S.
Features
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Customized closed system
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Minimal manipulation
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Rapid genetic modification
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Minimized risk of contamination
Suzhou GMP facility
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66,000 sq. ft. standalone manufacturing facility designed by a European company with rich experience in cell therapy manufacturing
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21,500 sq. ft. GMP clean area (5 functional areas)
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Approximately 97,000 sq. ft. of manufacturing facility to be expanded
