GI Cell Obtains Human Cell Management License and Meets All GMP Requirements

Advanced biopharmaceutical manufacturing facility of GI Cell (Photo by GI Cell)

[Asia Economy Reporter Chunhee Lee] GI Cell announced on the 27th that it has obtained the 'Human Cell Management Business' license under the Advanced Biopharmaceutical Safety and Support Act from the Ministry of Food and Drug Safety.

Following the acquisition of the advanced biopharmaceutical manufacturing license in December last year, GI Cell has now met all the requirements of the domestic Good Manufacturing Practice (GMP) regulations. This enables the stable production and supply of cells used in the development and clinical trials of cell therapies going forward.

To obtain the license, GI Cell established advanced biopharmaceutical manufacturing facilities and equipment, secured independent workspaces for managing manufacturing facilities, devices, equipment, raw materials, and supplies. They have built quality-related facilities, including aseptic culture rooms and filling rooms for cell therapy production, thereby establishing an organizational and quality management system compliant with GMP standards.

Kim Hyung-min, Head of the GMP Division (Executive Director) at GI Cell, stated, “Our goal for the first half of next year is to receive a favorable inspection result for the clinical trial application (IND) of the allogeneic NK cell therapy 'T.O.P. NK' and to obtain approval for the cell processing facility.” He added, “Through this, we hope to lay the foundation not only for the stable supply of clinical samples of our self-developed products but also for expanding our contract development and manufacturing organization (CDMO) business.”

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