Our mature and stable CMC platform technology enables large-scale, high-quality manufacturing.
Plasmid
- Mature and stable fermentation and purification technologies for Escherichia coli.
- In-process analytics monitor parameters such as supercoiled ratio, impurity profile, and endotoxin levels to ensure compliance with injectable-grade standards.
- Final plasmid products are sterilized through 0.22-μm filtration, filled in Class A environments, and stored under validated conditions.
- The capability to internally produce plasmids enhances vertical integration, strengthens supply reliability, and supports efficient technology transfer for both clinical development and commercial manufacturing.
Lentiviral Vector
- Our internally developed lentiviral vector platform provides a closed-system, automated, and scalable system for the production of high-quality gene delivery vectors.
- Each batch is subject to rigorous release testing — including identity, potency, sterility, residual DNA, and host-cell protein assays — to meet global quality and regulatory standards.
- The high degree of automation and scalability significantly reduces unit cost and production variability, providing a reliable foundation for consistent vector supply across both clinical and commercial programs.
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, and flow cytometry, and we can independently develop and verify analytical methods and manage data integrity to ensure compliance.
- QA：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 Facility
- A total GFA of approximately 7,866 square meters.
- Full-cycle production capabilities covering plasmids, viral vectors and CAR-T cells and in-house analytical and quality control capabilities.
- Granted the Drug Manufacturing License in February, 2022.
Shanghai Facility
- With a GFA of 32,306 square meters, the facility is located in the Shanghai Waigaoqiao Free Trade Pilot Zone.
- A team dedicated to the R&D and commercialization of cell and gene therapy drugs and antibody drugs.
Four Global R&D and Manufacturing Sites
Global R&D Center in Shanghai
GMP Manufacturing Site in Nanjing
Research and Clinical Manufacturing Site in Nanjing
