GC Cell Receives Approval for Korea's Largest Cell Therapy GMP Facility

GMP Approval for Yongin Cell Center Enables Annual Production of 20,000 Packs of Immuncell-LC Injection
Securing Korea's Largest Cell Therapy Manufacturing Facility
Full-Scale Launch of Global-Standard Cell Therapy CMO Business

[Asia Economy, reporter Park Hyungsu] GC Cell, a company specializing in cell therapy, announced on May 20 that it has received manufacturing approval for the GMP facility at its Cell Center in Yongin from the Ministry of Food and Drug Safety.

The Cell Center, located in Yongin, Gyeonggi Province, was completed in 2018 with a total floor area of 20,820 square meters (approximately 6,300 pyeong), consisting of two underground floors and four above-ground floors. Until recently, the company had been conducting tests and validation procedures to obtain GMP approval.

GC (Green Cross Holdings) and GC Cell jointly invested approximately 110 billion won in the Cell Center. Of this, 70 billion won was allocated to facilities and equipment optimized for cell therapy production and research and development.

With the manufacturing approval, the Cell Center can now produce up to 20,000 packs of Immuncell-LC Injection annually. The GMP production facility in Gasan-dong, Seoul, will be fully integrated and relocated to the Yongin Cell Center by the second half of this year.

The Cell Center is equipped with state-of-the-art facilities and production systems at the cGMP level, optimized for cell therapy manufacturing. An advanced computerized system has been introduced for enhanced management and production. It is the largest cell therapy production facility in Korea, meeting global standards.

Immuncell-LC Injection was approved as an anticancer drug for liver cancer in 2007 and completed Phase 3 clinical trials involving 230 patients. The results were published in 2015 in the world-renowned journal Gastroenterology, attracting global attention.

In addition, Immuncell-LC was the first domestic cell therapy product to achieve annual sales of 10 billion won in 2015, and reached approximately 35 billion won in 2019, firmly establishing itself as the leading cell therapy product in Korea.

The Cell Center is expected to play a key role in expanding synergy with the GC R&D Center in the specialized CMO business for cell therapy products and in the research and development of next-generation cell therapies.

Lee Deukjoo, CEO of GC Cell, stated, "With the manufacturing approval for the Cell Center, we are expanding the production capacity of Immuncell-LC Injection and expect to improve productivity and achieve long-term cost reductions." He added, "Through our cutting-edge production facilities, we plan to manufacture cell therapy products with world-class safety and quality."

He also emphasized, "We are fully launching our high value-added cell therapy CMO business and preparing to produce clinical trial drugs for the United States."

Immuncell-LC, the flagship immune-oncology product of GC Cell, is a personalized anticancer therapy made from the patient's own blood. It is manufactured using a special culturing process to maximize anticancer function, creating powerful immune cells that are administered to the patient. This new concept in anticancer therapy is gaining significant attention.

This content was produced with the assistance of AI translation services.