Manufacturing
Manufacturing Sites
Shanghai Waigaoqiao Manufacturing Site
- Approximately 4,200 square meters
- Primary sites for clinical manufacturing since the clinical trials of Carteyva® in 2018
- Design capacity: up to 400 batches of autologous CAR-T products per year (can support autologous CAR-T therapies for up to around 400 patients per year)
- In compliance with international cGMP and QMS standards
Suzhou Manufacturing Site
- Approximately 12,000 square meters
- Commercial and clinical manufacturing
- Four independent modules with design capacity of up to 5,000 batches of autologous CAR-T products per year (can support autologous CAR-T therapies for up to around 5,000 patients per year)
- In compliance with cGMP and QMS standards
End-To-End Process and Traceability Management
- To meet the management requirements of autologous CAR-T drugs over the whole process, JW Therapeutics designed the world's first end-to-end traceability system (COI/COC system), covering up to 18 control nodes, which also connects with the MES system (Manufacturing Execution System). By doing so, JW Therapeutics built a set of traceability systems that comply with GMP standards, and truly achieve digital and systematic real-time monitoring, traceability and management.