Manufacturing
Manufacturing and Testing Facilities in Shanghai and Suzhou
Shanghai Waigaoqiao Facilities
- Approximately 4,000 square meters
- Primary sites for clinical manufacturing since the clinical trials of relma-cel in 2018
- Design capacity:up to 500 patients
- 100% success rate for the manufacture of relma-cel throughout our Phase II DLBCL registrational clinical trial
- In compliance with international cGMP and QMS standards
Suzhou Facility
- Approximately 10,000 square meters
- Commercial and clinical manufacturing
- Four independent modules with design capacity of up to 5,000 autologous CAR-T patients
- In compliance with cGMP and QMS standards
End-To-End Process and Traceability Management
- Gradually build a set of traceability management conforming to drug management regulations, including the chain of identity, the chain of condition, and the chain of custody, to realize digital and systematic real-time monitoring, traceability and management
- Focus on safety, quality, delivery and cost, and work with logistic partner and hospitals to establish the CAR-T logistic process benchmark