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.
