Pilot Manufacturing Center @ Shanghai
•ACGT has a 4,000 m2 pilot-scale GMP-grade manufacturing facility for the production of clinical-grade cellular products in Pudong, Shanghai.
•The site contains a C-level R&D workshop, a B-level clinical-grade cell manufacturing workshop, a standard QC testing laboratory system, a cell bank storage room and other functional modules, which fully meet the needs of biopharmaceutical enterprises from discovery research, IND-enabling pre-clinical studies to clinical trial sample preparation.
•The facility is equipped with MAST-A type pulsating vacuum sterilizer, sterile isolator and other equipment that meets FDA GMP drug manufacturing standards. The cell storage center adopts a centralized supply system of liquid nitrogen, and a complete GMP verification document system has been established.
•Our MSC products used for clinical trials as well as iPS-derived cells used for IND application are manufactured in this facility.
Manufacturing Facility @ Anji, Zhejiang Province
•In the Life and Health Park, located in Anji of Zhejiang Province, one of China’s most scenic areas, a 30,000 m2 of cGMP Biologics Production Base is being completed. This production base consists of such functions as MSC production line, CAR-T/NK cell production line, NK production line, iPSC production line, fermentation workshop and plasmid production line, as well as warehousing, quality control and comfortable offices. Such a large area facilitates complete isolation of different production lines, with separate ventilation systems for different lines. The facility is designed by first-class industrial designers and fully meets the requirements of domestic GMP, US GMP, and EU GMP. To ensure pollution-free operation and product safety, technologies and devices such as sterile isolators, double leaf sterilization cabinets and VHP transfer bins are adopted.
•The facility is designed not only for the production of ACGT’s products alone. Our collaborators, in whatever form, will be invited to design and use respective functional units for production.
Product Storage & Transportation
Our UCMSC products are manufactured strictly following cGMP regulations and defined SOP. They are stored and transported properly with qualified logistics to the site of treatment, where they are stored, thawed and administered to the patient. Each treatment center is equipped with necessary devices for storage, thawing, sampling and other preparation purposes.