GC Green Cross Cell Becomes First in Korea to Obtain Human Cell Management Business License

First-Mover Advantage Expected Among Advanced Biopharmaceutical Manufacturers
CDMO Revenue Surged 524% Year-on-Year Last Year

[Asia Economy, reporter Park Hyungsoo] GC Green Cross Cell, a cell therapy developer, announced on March 2 that it has become the first among domestic advanced biopharmaceutical manufacturers to obtain the “Human Cell, Etc. Management Business License.”

The Human Cell, Etc. Management Business License is one of the newly established requirements following the enforcement of the “Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals.” This license is required to collect, process, and supply human cells and other materials used as raw materials for advanced biopharmaceuticals.

Since the raw materials for cell therapies must be extracted from humans or other cells or tissues, a separate Human Cell, Etc. Management Business License is required for contract manufacturing of cell therapies, in addition to the advanced biopharmaceutical manufacturing license.

With this license, GC Green Cross Cell has become the fastest among domestic contract development and manufacturing (CDMO) companies to be able to produce cell therapies.

Last year, CDMO revenue from U.S.-based Artiva Biotherapeutics and GC Green Cross LabCell increased by 524% compared to the previous year. The company plans to focus on increasing revenue this year through the expansion of its CDMO business.

Lee Deukjoo, CEO of GC Green Cross Cell, stated, “With the Human Cell, Etc. Management Business License, we believe we have secured a leading position in the domestic cell therapy CDMO business.” He added, “The Cell Center is equipped with state-of-the-art cGMP-level facilities and production systems optimized for cell therapy manufacturing.” He continued, “By introducing advanced management and production systems, we have established the largest cell therapy manufacturing facility in Korea that meets global standards.”

With the emergence of CAR-T therapies, the global cell therapy CDMO sector is attracting significant attention. GC Green Cross Cell is strengthening its competitiveness in the specialized cell therapy CDMO business by leveraging its expertise in approval, production, and sales of cell therapies.

Last year, GC Green Cross Cell achieved sales of KRW 35.6 billion from Immuncell-LC. The company is currently developing a CAR-T therapy targeting solid tumors.

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