NKCL Bio Group Inc., Acquired Manufacturing Permit for Advanced Biopharmaceuticals

2023.01.25 11:54 조회 360


As part of the policy pledge of the new government in 2022, in relation to fostering the advanced bioindustry, which is attracting attention as a growth engine industry, pharmaceutical and bio companies are announcing the latest biopharmaceutical manufacturing permits.

This is interpreted as ‘legal preparations completed’ that require obtaining related permits after the enforcement of the ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ also known as the ‘Advanced Regen Act’.

NKCL Bio Group Inc. obtained the permit to manufacture advanced biopharmaceuticals in January this year, becoming the first bio company obtained the permit in the new year. NKCL Bio Group is a bio company that manufactures immuno-anticancer cell therapy products based on NK cell culture technology. By obtaining a manufacturing license for advanced biopharmaceuticals, the NK cell automatic culture center and manufacturing facilities established in 2022 will be used to produce advanced biopharmaceuticals. A company official said that it was proven that it met all the conditions for manufacturing.

According to the current law, the ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals’, only companies equipped with facilities prescribed by the Presidential Decree and approved by the Minister of Food and Drug Safety can handle cell therapy products and gene therapy products.

In order to obtain permission to manufacture advanced biopharmaceuticals, various strict requirements set forth in the law must be met including the following areas.

▲workplace, equipment, and equipment where the manufacturing process is completely performed ▲test and laboratory for quality control of raw materials, materials, and advanced biopharmaceuticals, and equipment and equipment necessary therefor ▲safe and sanitary storage Location and facilities ▲ a record storage room with access security devices for manufacturing facilities and equipment for recording and storing business records, as well as other equipment and manpower.

In order to collect and process human cells, which are raw materials for advanced biopharmaceuticals, and supply them to regenerative medical institutions, it is necessary to have facilities, manpower, and equipment prescribed by the Presidential Decree, and obtain permission for human cell management business and cell processing facility permission.

Accordingly, NKCL Bio Group, which announced its acquisition of a manufacturing permit, has also announced its policy to produce clinical trial drugs for related platforms, once the acquisition of human cell management business licenses and reporting of cell processing facilities are completed in the near future.

Recently, as Daewoong Pharmaceutical has also obtained permission for the management of human cells following the manufacturing license acquisition for advanced biopharmaceuticals, NKCL Bio Group is also planning to accelerate its advanced biopharmaceutical CDMO business. 

In addition, as the NKCL Bio Group was notified at the end of 2022 of the confirmation of patent registration from the United States for the NK cell culture technology, which had obtained a technology patent in Korea as a result of its focus on research and development, with this advanced biopharmaceutical manufacturing permit, NKCL Bio Group has been fully equipped with the foundation to promote full-scale clinical trials on cell therapy.

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