Biostar Stem Cell Research Institute of Korea, completes the application process for obtaining approval of stem manufacture from MHLW of Japan

• Korea’s first stem cell facility to complete the application process
• Stem cells are to be cultured in Korea and be supplied to the medical institutions in Japan starting this year

The Biostar Stem Cell Research Institute, jointly run by Nature Cell and R Bio, made an announcement on August 13 that it has submitted an application to the Ministry of Health, Labour and Welfare (MHLW) of Japan for an approval of manufacturing processed cellular products at a cell processing center in Korea.

The acquisition of MHLW’s approval for the manufacture of processed cellular products by R-Japan, an affiliate of Nature Cell, earlier in June, and the recent application submitted for the cell processing center in Korea are expected to accelerate the global standardization process of the domestic stem cell technology pursued by Biostar.

According to the Regenerative Medicine Law of Japan, stem cell processing facilities based abroad are able to culture stem cells and supply to the medical institutions in Japan after obtaining manufacturing approval from MHLW.

Dr. Ra Jeong-chan, the President of the Biostar Stem Cell Research Institute, said, “We expect the inspection and review process of the Ministry of Health, Labour and Welfare of Japan to take about 3 months. The Japanese government’s approval of our research institute in Japan and the cell processing center in Korea is of important significance as we will be able to lead the global standardization process with our technology.”

Japan has designated regenerative medicine as a national growth engine, and changed the system from allowing doctors at hospitals and medical clinics to engage in cell cultivation and processing practices to requiring MHLW’s approval of the processed cellular product manufacturing facilities to guarantee safety. Also, a regenerative medicine treatment plan must be approved by an expert committee before it can be applied in a clinical setting.

The Biostar Stem Cell Research Institute plans to establish a cooperation network with multiple medical institutions in Japan by this November as a means to broaden the scope of autologous stem cell therapy to treat rare and intractable disease patients from around the world.