NKCL Bio Group, a high-tech biopharmaceutical manufacturing company, has obtained a cell processing facility permit under the Advanced Regenerative Bio Act from the Ministry of Food and Drug Safety(MFDS).

Accordingly, NKCL Bio Group announced on the 24th that it will focus on the cell therapy business. NKCL Bio Group previously obtained permission to manufacture advanced biopharmaceuticals in January.

Permission for a cell processing facility means that it is equipped with professional facilities and qualifications that can process human cells in advanced regenerative medicine clinical research. For permission, the standards announced by the MFDS, such as cell processing manufacturing facilities, devices and equipments, and independent testing laboratories for raw materials, materials and quality control, must be met. Recently, in addition to NKCL Bio Group, Daewoong Pharmaceutical, Yonsei University Gangnam Severance Hospital, and Cha Medical University Bundang CHA Hospital have been approved.

Currently, there are about 30 places that have received permission for cell processing facilities nationwide, and around 10 companies that have received permission for both 'Advanced Biopharmaceutical Manufacturing Business' and 'Cell Processing Facility' after the enforcement of the Advanced Regenerative Biopharmaceuticals Act.

Donghwa Shin, Chairman of NKCL Bio Group, said, “We have obtained a manufacturing license and built a cell processing facility at the same time, so collection and inspection are possible, and we are qualified to supply processed cells to medical institutions.” “Support for government tasks during clinical research. I was able to accept it and move on.”

In addition, he said, "We have succeeded in miniaturizing the NK cell automatic culturing system that enables mass production of cell therapeutics, and we plan to release a prototype 'Automatic Culture System for one person' in April." He also explained, "We plan to expand the cell processing clinical research institute to clinic-level hospitals."

NKCL Bio Group is researching and developing customized medicine, including cell therapy, through industry-academia cooperation with Hanyang University. Within this year, major university hospitals and medical institutions will begin clinical trials for four cancer diseases.

An official from NKCL Bio Group said, "With this cell processing facility permission, we will officially register the NK cell automatic culture system, and we will accelerate our entry into the high-tech biopharmaceutical consignment development and production market."

https://www.ajunews.com/view/20230324172050114