Hsinchu builds the world's first PIC/SGMP-compliant stem cell pharmaceutical factory

Hsinchu builds the world's first PIC/S GMP-compliant stem cell pharmaceutical factory

The world's first stem cell preparation factory that complies with PIC/S GMP regulations broke ground on the 12th in Hsinchu Biomedical Park. In order to meet the market demand for new stem cell drug preparations after clinical trials, Guoxi Stem Cell Company held a groundbreaking ceremony for the preparation pharmaceutical factory, which is scheduled to be completed and operated by the end of 2018. Qiu Jingchun, head of Hsinchu County, and du Qixiang, director of the Science Park, were there to offer congratulations, hoping that Guoxi would lead Taiwan's stem cell new drug industry to become one of the most advanced medicine in the world.

Guoxi Stem Cell Co., Ltd. is expected to invest 500 million yuan to build a new pharmaceutical factory, covering an area of 0.44 hectares, with a total construction area of about 4500 ping, with a structure of two floors underground and five floors above ground. At the initial stage, it is planned to have an annual production capacity of 100000 doses of stem cell preparations. In the future, in addition to producing new stem cell drugs developed by Guoxi Stem Cell Company itself, it is also commissioned by the academic, clinical, and industry to carry out production and manufacturing. it is expected to speed up the research and development of new stem cell drug products and market, and promote the active development of the domestic stem cell industry through the resources of production capacity.

Guoxi Stem Cell Company, located in Hsinchu Biomedical Park, is the first manufacturer in China to develop new stem cell drugs. after years of research and testing, two new stem cell drug products have entered human clinical trials, namely, stem cell drugs for the treatment of liver cirrhosis "GXHPC1" and stroke "GXNPC1". At the same time, ten candidate new drugs have completed animal trials. Stem cells are the main raw materials of stem cell preparation pharmaceutical factory, so in the manufacturing process, not only the basic PIC/S GMP drug specifications, but also the whole production process need to comply with the good practices of human cells and tissues (Good Tissue Practice, GTP), in order to achieve the goal of product safety, effectiveness and consistent quality.

▲ Hsinchu builds the world's first PIC/S GMP-compliant stem cell pharmaceutical factory