TS Bio Obtains MFDS Approval for Advanced Cell Processing Facility... Enters Cell Therapy Market

[Asia Economy Reporter Hyunseok Yoo] TS Bio, which acquired HL Biopower, a KOSDAQ-listed company, announced on the 12th that it received approval from the Ministry of Food and Drug Safety on the 9th for the cell processing facility permit related to its GMP (Good Manufacturing Practice) facilities.

Among domestic cell therapy developers, TS Bio is the third company, following Cha Biolab and AlvBio, to obtain both the advanced biopharmaceutical manufacturing license and the cell processing facility permit.

Last August, the government strengthened the system through the enforcement of the Advanced Regenerative Medicine Act, which previously allowed the manufacturing and sales of cell therapies with only a general pharmaceutical manufacturing license. To collect, process, and supply various cells or tissues such as stem cells, hematopoietic cells, somatic cells, and immune cells, it is now mandatory to acquire both the advanced biopharmaceutical manufacturing license and facility permit.

Through the newly approved cell therapy facility permit, TS Bio plans to develop cell therapies using autologous adipose-derived stem cells and immune cells (NK Cells), as well as expand into CMO (CDMO) business and human cell storage services, which require the latest facilities and expertise.

TS Bio completed a smart GMP factory in 2019 for technology transfer and cell therapy production through collaboration with the Japanese bio company Kojin Bio in 2018. Currently, it is undergoing approval procedures with Japan’s Ministry of Health, Labour and Welfare to use stem cell and immune cell therapies manufactured in GMP facilities locally in Japan. Additionally, TS Bio is developing anticancer drugs using NK immune cells, which have relatively fewer side effects and excellent efficacy, as well as various therapies using adipose-derived stem cells.

Lee Hyung-seung, CEO of TS Bio, stated, “With this certification of the cell processing facility under the Advanced Regenerative Medicine Act, it has become possible to supply processed cells to domestic hospitals approved as regenerative medical institutions,” adding, “We will open a new chapter in the domestic and international cell therapy field through joint research and cooperation with major domestic hospitals.”