Hsinchu to Build the World's First PIC/S GMP-Compliant Stem Cell Drug Manufacturing Plant

The world's first stem cell drug manufacturing plant compliant with PIC/S GMP standards broke ground on the 12th at the Hsinchu Biomedical Science Park. In order to bridge the market demand for stem cell new drug formulations following clinical trials, Guoxi Stem Cell Company held a groundbreaking ceremony for the manufacturing plant, with completion and operation scheduled before the end of 2018. Hsinchu County Magistrate Chiu Ching-chun and Science Park Administration Director-General Tu Chi-hsiang attended to wield shovels for the groundbreaking and offer congratulations, expressing hope that Guoxi will lead Taiwan, China's stem cell new drug industry into the ranks of advanced international medicine.

Guoxi Stem Cell Company plans to invest 500 million yuan to build a brand-new manufacturing plant, covering an area of 0.44 hectares with a total floor area of approximately 4,500 ping, as a building structure with two basement levels and five above-ground levels. The initial planned annual capacity is 100,000 doses of stem cell formulations. In the future, in addition to producing stem cell new drugs developed by Guoxi Stem Cell Company itself, it will also accept contract manufacturing commissions from academia, clinical institutions, and industry, which is expected to accelerate the research, development, and market launch of stem cell new drug products, and through capacity resources, enhance the vibrant development of the domestic stem cell industry.

Guoxi Stem Cell Company, located in the Hsinchu Biomedical Science Park, is the first domestic manufacturer to develop stem cell new drugs. After years of research, development, and testing, it currently has two stem cell new drug products entering human clinical trials, namely the stem cell drug "GXHPC1" for treating liver cirrhosis and "GXNPC1" for treating cerebral stroke. At the same time, ten candidate development drugs have completed animal testing. Because the primary raw material for production at the stem cell drug manufacturing plant -- stem cells -- is a living material, the manufacturing process must not only comply with basic PIC/S GMP drug regulations, but the entire production process also needs to comply with Good Tissue Practice (GTP) to achieve the goals of product safety, efficacy, and consistent quality.