NKCL Bio Group, a Korean
bio-company that research and develops immune cell therapy, is attracting
attention as a beneficiary company of ‘the Act on the Safety and Support of
Advanced Regenerative Medicine and Advanced Bio-Pharmaceuticals' (hereinafter
referred to as the Advanced Medicine Act).
In addition, NKCL increased the number of cell acquisition through the
specialization of the culture environment optimized for cell to grow. While the
conventional cell culture technology showed a yield of 2 to 4 billion cells, NKCL’s
method had yielded significantly higher number of 200 to 300 million cells. In
addition, while NK cells normally attack all of the abnormal cells in the body,
NKCL possesses technology that makes NK immune cells to target on cancer cells.
The ‘Advanced Medicine Act’ is a law established under the concept of more
systematic management of biopharmaceuticals, such as cell therapy products made
by culturing living cells, and making the time required for the R&D and
release of the product significantly shorter, in order to save patients and
improve the quality of their life. The Ministry of Food and Drug Safety and the
Ministry of Health and Welfare said on the 25th that the enactment of the
Enforcement Decree of the 'Advanced Medicine Act' has passed the cabinet meeting.
As scheduled, the bill was announced in August of last year, and it will take
effect from the 28th of this month.
When the ‘Advanced Medicine Act’ is implemented, many bio company products are
expected to benefit from the legislation. Among them, NK cell therapy,
owned by NKCL Bio Group, is a biopharmaceutical that falls under this 'Advanced
Medicine', and the group is expected to benefit most from the early entry into
clinical trials and early commercialization of its product.
An official from the Ministry of Health and Welfare said that in a situation
where it is difficult to carry out work due to the COVID-19 crisis, the
government's subordinate laws, essential organizations, and budget preparation
work, which are essential for the enforcement of the law, have been somewhat delayed,
but the law could be enforced within this year. Accordingly, NKCL's cell
therapy business is expected to accelerate as well.
The major competitiveness of NKCL Bio Group is the NK immune cell automation
system. NK cell culture is fully automated by adopting artificial
intelligence (AI) technology which finds an optimized culture environment by
itself, breaking away from the existing cell culture method that relies on the
entire culture process by highly specialized researchers. By controlling
the culture process with artificial intelligence, human errors can be prevented
in advance and “data leakage” due to manpower outflow can be avoided. This
solves the shortage problem of highly qualified human resources at Culture
Research Institute, and increases productivity by more than 100 times to vastly
reduce the cost of treatment.
NKCL Bio Group held a construction start ceremony for its automated NK cell
culture system of about 1,200 sqm in Dongtan New Town in Hwaseong, Gyeonggi-do
on December 30 last year, and it is on its way to receive GMP certification as
a cell culture facility.
The NKCL Bio Group’s official said, "As the Advanced Medicine Law is
implemented, we are working hard on the completion of the automation facility
in accordance with the relevant regulations. We will put all our effort on not
only alleviating the pain of numerous patients, but also to become a Korean bio
company responsible for the immunity of people around the world.”