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Manufacturing

Manufacturing Sites
Shanghai Waigaoqiao Manufacturing Site

 

Shanghai Waigaoqiao Facilities
  • 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.

 

Information as of: March 2023

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