“KangStem Biotech aims to become a leader in the global stem cell therapy market with the recent completion of a factory for a stem cell treatment.”
So said CEO Lee Tae-hwa during a ceremony to celebrate the dedication of what he said was the world’s largest-capacity plant to manufacture stem cell therapies, on Wednesday.
The new Stem Cell GMP Center is capable of producing five times more drugs compared to the previous facilities, the company said. The new plant, located at SK Techno Park in Gwangmyeong, Gyeonggi Province, can annually manufacture 36,000 vials of Furestem-AD, an investigational stem cell therapy for atopic dermatitis.
|An inside view of KangStem Biotech’s Stem Cell GMP Center|
Last year, KangStem Biotech poured 20 billion won into the expansion of the plant, and the construction began in November. Located at the sixth floor of SK Techno Park, the factory covers a 2,644-square meter area consisting of a core manufacturing facility, a test lab, and a storage room.
“The previous GMP facility could manufacture 5,000-6,000 vials a year. It used to produce test materials for clinical trials mainly. The newly established facility is the world’s largest, in terms of manufacturing a stem cell drug,” said Kang Kyung-sun, chairman of the board of KangStem Biotech.
The manufacturing area is where umbilical cord blood is injected. It consists of a secondary packaging room, sterilization rooms, and a storage room for frozen cells.
The quality control test lab has a central lab for analyzing the drug’s potency and purity. Here, the drug’s main ingredient umbilical cord blood is analyzed. Equipped with a sterile room for safety tests, the lab also performs microwave plasma testing, aseptic testing, and exotic virus testing. The storage facility saves raw materials and finished products. It has a 2-8 degrees refrigeration room and a minus 80 degrees freezer storage.
When umbilical cord blood enters the center, the mesenchymal stem cells are isolated, cultured, and frozen after cryopreservation. Raw materials can be stored for up to two years. These raw materials are thawed later and filled into injections.
KangStem Biotech said it aimed to obtain not only Korean GMP (Good Manufacturing Practice) certification for the new factory but current GMP (cGMP) to enter the global market. To do so, the company is conducting a self GMP validation on the facilities and equipment. The company plans to seek local GMP and approval for Furestem-AD in the first quarter next year.
|KangStem Biotech CEO Lee Tae-hwa (left) speaks during a press conference at the Stem Cell GMP Center in Gwangmyeong, Gyeonggi Province, on Wednesday. At right is Senior Managing Director Ahn Byoung-woo.|
Ahn Byoung-woo, senior managing director of the strategic planning division at KangStem Biotech, said quality control was a crucial factor for a biopharmaceutical firm.
“Having its manufacturing facilities and being able to control the production line steadily is fundamentally different from entrusting the production to a contract manufacturing organization (CMO),” Ahn said.
The company hopes to receive GMP certification next year and approval for Furestem-AD in late 2020 to produce the drug in earnest.
<© Korea Biomedical Review, All rights reserved.>