On January 20, 2021, the Hrain’s cell preparation center in Shanghai Jinshan Industrial Park was officially completed, marking that Hrain has entered a new stage of industrialization. The manufacturing center has an area of 11,000 square meters, and the estimated annual production capacity is 3,000-6,000 cases.
Hrain CAR-T cell preparation center is designed and constructed in strict accordance with the EU GMP standard ("EU Good Manufacturing Practice", which focuses on the combination of dynamic and static control of the drug production process, which is more stringent than the US FDA standard), and has been approved by the 2020 Demonstration Clean Project Commendation Project issued by the Shanghai Indoor Environment Purification Industry Association.
The production area is designed with unidirectional flow to avoid cross-contamination. The quality control area can realize CAR-T production life cycle testing. The storage area is equipped with the most advanced refrigeration technology equipment, as well as automatic liquid nitrogen automatic replenishment system, EMS temperature online monitoring system. In addition, the preparation center has built a multi-in-one control center and built an IT room in accordance with the requirements of the network security level protection 2.0 system (network security level protection 2.0 system, implemented on December 1, 2019, to realize the security and credibility, dynamic perception and comprehensive audit of the whole process of the information system before, during and after the event). The high standard equipment and facilities lay the foundation for the high quality production and preparation, and are ready for the future industrialization of Hrain.
Since its establishment, Hrain has been committed to the independent research and development of cell immunotherapy and technology transformation, forming a product pipeline layout with CAR-T technology as the leading, and TCR-T, CAR-NK, oncolytic virus therapy and other research and development projects promoted in parallel. To date, the company has obtained four clinical approvals, one of which is the first dual-target CAR-T registered clinical approval in China, and the other three approvals are in phase I/II clinical studies. Hrain has obtained 12 invention patents, nearly 20 practical patents, and 3 international PCT patents, in addition to nearly 90 invention patent applications have been submitted. In 2020, the company obtained GB/T 29490-2013 Enterprise Intellectual Property Management System (IPMS) certification, and independently undertook an industrialization project of the Ministry of Industry and Information Technology. At the same time, the company has carried out in-depth exchanges and cooperation with enterprises and scientific research institutes such as City of HOPE, Virogin Biotech Ltd. and Shanghai University of Science and Technology.