CDMO

Full Chain CDMO Services

CDMO

Jingze has built a CMC R&D center in Shanghai and an industrialization base in Chengdu, which can provide the whole chain of CDMO services. At present, , Jingze has successfully provided new drug development services (received clinical approval for new drugs) and process scale-up and production services for many companies and organizations.

The CMC R&D center in Shanghai is located in North Shanghai Biomedical Industrial Park with an experimental area of about 3000㎡, and is a national high-tech enterprise. The center has eukaryotic and prokaryotic production, formulation pilot plant and non-GMP process development laboratory under GMP conditions. Among them, the eukaryotic workshop has 20 sets of 2L reactors, 50L WAVE bioreactors, 2×250L pilot production lines, and the prokaryotic workshop has 100L pilot production lines based on E. coli and yeast. Equipped with HPLC, UPLC, MS, RT-PCR, Maurice, capillary electrophoresis and other high-end precision analytical instruments, the center can provide a full range of quality testing and quality control services.

Chengdu's R&D and industrialization base is located in Wenjiang Medical City, covering an area of 101 mu.  The plant and hardware of the first stage of the project are in compliance with NMPA, FDA and EMEA GMP standards, and the key equipment and facilities are all international mainstream or domestic first-line brands. Now, two 2000L Sartorius and 2×250L eukaryotic stock solution production lines have been built, using discarded bioreactors, which can realize the rapid switching production of different species at the same time; and one 500L prokaryotic stock solution production line. In addition, we have also built freeze-dried powder injection (10㎡) and water injection( injection and solution for injection) preparation production lines, cassette bottle and pre-filled needle preparation production lines, with the production capacity of various dosage forms.