GMP Manufacturing
Quality
Our Manufacturing Facilities
we are operating one GMP-compliant manufacturing facility in Shanghai, with a GFA of approximately 1,000 sq.m. The facility had an annual production capacity of around 90 billion cells in each year of 2024 and 2025, which is sufficient to support our ongoing clinical trials and early commercialization. we own all equipment and machinery used in our production process.
We plan to build additional facilities of an aggregate GFA of approximately 10,000 sq.m. in China. In particular, we already leased a premise of 2,964.19 sq.m. in the Shanghai Free Trade Zone, on which we plan to build an additional manufacturing facility.
Capacity & Automation
We are developing an intelligent automated cell culture platform based on our R-Clone epithelial stem cell cloning platform jointly with leading market players in regenerative medicine — the Intensive Automated Cell Culture Workstation (the “Workstation”). By integrating automation, intelligent systems, digitalization, artificial intelligence, and image-processing technologies, the Workstation enables one-stop cell preparation covering the entire workflow. Compared with conventional manual operations, the Workstation offers principal advantages in the respects of: (1) safety and reliability; (2) quality control; and (3) efficiency and intelligence. It will advance the industrialization of cell therapy manufacturing, delivering high-quality cell products with greater efficiency and consistency.