The groundbreaking ceremony for Gwoxi Stem Cell Applied Technology Co., Ltd.’s new stem cell medicine factory was held in Hsinchu Bio-medical Park on May 12. It is expected that the factory will begin operating at the end of 2018, meeting market needs following the completion of stem cell medicine clinical testing. County Magistrate Chiu, Ching-chun wielded a shovel and broke the ground together with Director General of the Hsinchu Science Park Bureau, Tu, Chi-hsiang, expressing the hope that Gwoxi will drive the development of Taiwan stem cell medicine industry and take Taiwan’s medical science to a leading position internationally.
Magistrate Chiu congratulated Gwoxi on reaping the rewards of its efforts over the past few years, saying that Hsinchu County Government fully supports all the industries in the bio-medical park. He wished the company every future success. Director General Tu said that Gwoxi is the first stem cell medicine factory to be PICS/GMP certified in Taiwan and looked forward to the company providing high quality human stem cell medical services on the strength of excellent R&D.
Chairman of Gwoxi Chuang, Ming-his thanked the county government for the support given from the planning stage to groundbreaking and also thanked the Bureau for assisting with its land application. The significance of the groundbreaking; he said, was that it marked the move into the medicine factory stage of Taiwan’s stem cell medicine industry. Future mass production will allow medical science in Taiwan to make great leaps forward and achieve a leading position internationally.
Gwoxi is investing an estimated NT$500 million in its new factory. On a 0.44-hectare site, it will have building area of around 13,600 square meters and have two basement floors and five above ground. It is design and construct by Wishun Building Co. It is estimated that the factory will be up and running at the end of 2018. Initial capacity is planned as 100,000 stem cell preparations annually. In future, as well as producing stem cell new medicines that are self-developed, it will also manufacture them for academic institutions, clinical testing and other companies under contract, speeding up the stem cell new medicine R&D and market entry process, and using its capacity to stimulate the growth of the stem cell industry in Taiwan.
Gwoxi is the pioneer in stem cell medicine R&D in Taiwan. After years of R&D, at present, two stem cell new medicines are at the clinical testing stage, namely GXHPC1 for the treatment of liver cirrhosis and GXNPC1 for the treatment of strokes.
As the main material produced by a stem cell medicine factory is living material, the production process doesn’t just have to meet PICS/GMP drug requirements, it also has to fulfill the requirements of Good Tissue Practice (GTP) to achieve the objectives of safety, effectiveness and uniform quality.