GC Cell wins Japanese certification for cell therapy manufacturing facili...

GC Cell announced Wednesday that it has received certification for its Cell Processing Center (CPC) from Japan’s Ministry of Health, Labour and Welfare (MHLW), marking a major regulatory milestone for its cell therapy manufacturing operations.

The certification followed a successful on-site inspection by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in late 2025. The approval formally confirms that GC Cell’s cell therapy manufacturing facilities and quality management systems comply with Japan’s rigorous regulatory standards for regenerative medicine, the company said.

GC Cell headquarters in Yongin, Gyeonggi Province. (Credit: GC Cell)

Japan’s CPC certification system is designed to rigorously oversee manufacturing facilities and processes in regenerative medicine and cell therapy. Overseas manufacturing sites must adhere to the same stringent standards as domestic facilities. With the approval, GC Cell has demonstrated that its manufacturing and quality systems meet global regulatory requirements.

With this certification, GC Cell has established the legal basis to supply its approved Immuncell-LC Injection and investigational CD5 CAR-NK candidate to Japanese medical institutions. The achievement not only allows entry for specific products but also provides access at the manufacturing platform level, strengthening GC Cell’s infrastructure for future market expansion.

The company said the certification serves as a key regulatory gateway to Japan’s regenerative medicine and cell therapy market and is expected to facilitate clinical research, academic collaborations and discussions on commercial supply in the country.

Building on this foundation, GC Cell plans to expand partnerships with local medical institutions and accelerate its broader strategy to enter the Asian market, with Japan serving as a regional hub.

“This CPC certification officially validates that GC Cell’s systems meet global standards," Co-CEO Won Sung-yong said. "We will continue advancing strategies to expand access to cell therapies worldwide.”

GC Cell said it will leverage its validated manufacturing quality to strengthen its pipeline and expand its CDMO business for domestic and international partners.

Lee Han-soo