GC Cell announced on Wednesday that it has received final certification for the manufacture of specific cell processing products (CPC) from Japan’s Ministry of Health, Labour and Welfare (MHLW).
This certification comes after successfully passing an on-site inspection by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) late last year. It officially recognizes that GC Cell’s cell therapy manufacturing facility and quality management system meet Japan’s stringent regulatory standards for regenerative medicine.
Japan’s specific cell processing product system rigorously oversees manufacturing facilities and processes in regenerative medicine and cell therapy, applying the same standards to both domestic and overseas facilities.
This approval demonstrates GC Cell’s ability to meet Japan’s demanding regulatory requirements, showcasing its world-class manufacturing and quality competitiveness.
With this certification, GC Cell has secured the legal foundation to supply its approved product, Immuncell-LC, already marketed in South Korea, and CD5 CAR-NK (GCC2005), a cell gene therapy currently in Phase 1 clinical trials in Korea, to Japanese medical institutions.
GC Cell’s Chief Executive Officer (CEO), Won Seong-yong, stated that this manufacturing certification is a significant milestone, officially validating the manufacturing and quality systems as meeting global regulatory standards. It’s committed to aggressively pursuing clinical and commercialization strategies to offer new treatment options for patients.
GC Cell, a specialized subsidiary of the GC Green Cross group focusing on cell and gene therapy, is advancing the development of next-generation cell therapies, including immune cell-based cancer treatments and CAR-NK, while also providing contract manufacturing (CMO) services.