NKCL Bio Group (Chairman Donghwa Shin), an advanced biopharmaceutical manufacturing company, announced on the 22nd that it had obtained permission for a cell processing facility based on the advanced regenerative bio method from the KFDA.
NKCL Bio Group acquired permission to 'Manufacturing of Advanced Biopharmaceuticals' from the KFDA in January 2023, and it will be equipped with a cell processing facility recognized by the KFDA in March.
Therefore, the cell therapy business has been accelerated among the advanced biopharmaceuticals mentioned in the Advanced Bio Act, etc.
Cell processing facility permission means that it has specialized facilities and qualifications to process human cells in advanced regenerative medicine clinical research. In addition to NKCL Bio Group, Daewoong Pharmaceutical, Yonsei University Gangnam Severance Hospital, and CHA Medical University Bundang CHA Hospital have recently received permission for cell processing facilities.
Currently, there are about 30 places that have received permission for cell processing facilities nationwide, and after the enforcement of the Chemistry Act, the number of companies that have received both the “Advanced Biopharmaceutical Manufacturing Business” license and the “Cell Processing Facility” license is more limited to about 10 companies.
In order to obtain permission for a cell processing facility, it is necessary to meet strict standards notified by the KFDA, such as manufacturing facilities, equipment and facilities capable of cell processing, and independent testing laboratories for raw materials, materials and quality control. In addition, requirements such as storage facilities, personnel, and operating systems that can safely store equipment, reagents, and cells necessary for inspection must be met.
The NKCL Bio Group simultaneously establishes a cell processing facility certified by the Ministry of Food and Drug Safety and an advanced biopharmaceutical manufacturing license stipulated by the Act on Advanced Regenerative Medicine and Advanced Biopharmaceutical Safety and Support, so that human cells collected, inspected, and processed within the cell processing facility are Qualified to supply to regenerative medicine institutions. In addition, during clinical research at regenerative medicine institutions, government tasks can be supported and conducted.
NKCL Bio Group is researching and developing customized medicine, including cell therapy, through industry-academia cooperation with Hanyang University. In addition, it will successfully complete preclinical trials on four cancer conditions in 2022, and start clinical trials with major university hospitals and medical institutions in 2023. RK-NKTM, developed by NKCL Bio Group and undergoing clinical research, has been reported to show excellent results, such as showing up to 99.5% anti-cancer effect in toxicity test and immuno-anticancer ability, compared to chemical anti-cancer drugs in pre-clinical tests.
In addition, NKCL Bio Group succeeded in miniaturizing the NK cell Automatic Culture System that enables mass production of self-developed cell therapy products, and launched the RK-NKTM ACS prototype, an automatic culture system for one person, in APR 2023. They are preparing to expand the cell processing clinical research institute to the clinic level.
NKCL Bio Group, which has officially registered its NK cell automatic culture system with this cell processing facility license, is expected to accelerate its entry into the ‘Contract Development & Manufacturing Organization’(CDMO) market through advanced regenerative medicine cell processing facilities.