R&D and Production
In-house production from plasmids to cells
Plasmids
In-house plasmid production supports clinical and commercial manufacturing.
Fermentation and purification
Mature and stable fermentation and purification technologies for Escherichia coli.
Process monitoring
In-process analytics monitor parameters such as supercoiled ratio, impurity profile, and endotoxin levels to ensure compliance with injectable-grade standards.
Filtration and filling
Final plasmid products are sterilized through 0.22-µm filtration, filled in Class A environments, and stored under validated conditions.
In-house supply
The capability to internally produce plasmids enhances vertical integration, strengthens supply reliability, and supports efficient technology transfer for both clinical development and commercial manufacturing.
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
GMP Manufacturing Site in Nanjing · R&D Center in the U.S.
