NKCL Bio Group will accelerate the cell therapy business in accordance with the implementation of the Advanced Regenerative Medicine Act

NKCL 2020.08.31 18:20 조회 814
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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).

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.

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 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.”
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