Our mature and stable CMC platform technology enables large-scale, high-quality manufacturing.
Plasmid
- Establishing a strain library in line with the requirements by the Chinese Pharmacopoeia
- Mature and stable fermentation and purification technologies for Escherichia coli
- Scale: 10 L/50 L for IND filings and clinical research
Lentiviral Vector
- Technology：
- Serum-free 3rd generation 4-plasmid lentivirus packaging system
- Mature and stable large-scale adherent cell culture & purification technologies
- Serum-free medium used for lentiviral vector packaging
- Scale: 24 CF10 for IND filings and clinical research
- Capacity: 4,000 Lentiviral vectors per year, 100 patients per batch
Cells
- Technology: rapid cell product process development for GMP-compliant manufacturing
- Cost: A systematic platform built for sequence screening, research and manufacturing of GMP grade plasmids, viral vectors and cells with a cost advantage
- Quality：The quality of cell products is stable and controllable. The safety and efficacy are superior to those of other similar products
Quality
- QC： We’ve set up technology platforms covering molecular detection, cell functions, flow cytometry, and NGS, and we can independently develop and verify analytical methods and manage data integrity to ensure compliance.
- QA：All staff have extensive experience as they previously worked with large pharma companies. We adopt the most advanced quality control system in China, and expand the scope of management based on the particularity of CAR-T
Plasmid
Lentiviral Vector
Cells
Quality
Commercialization Facility
Nanjing International Commercialization Facility
- Over 100,000-sqft facility for commercial manufacturing
- Full-cycle production capabilities covering plasmids, viruses and CAR-T cells and in-house analytical, QA/QC capabilities
Shanghai International R&D Center & Manufacturing Base
- The base, covering an area of 64,000 square meters, is located in Shanghai Waigaoqiao Free Trade Pilot Zone.
- The company will form a globally leading team at the base to develop advanced cell therapies drug and biological agents
See more company facilities
Shanghai International R&D Center
Nanjing International Commercialization Facility
