GWOXI PIC/S GMP Cell Preparation Factory Is Expected to Obtain Certification by October 2025
Gwo Xi Stem Cell PIC/S GMP Cell Preparation Factory is located in Hsinchu Biomedical Science Park.
Gwo Xi Stem Cell (TPEx: 6704) has recently achieved several significant milestones. Gwo Xi Stem Cell is the first company developing stem cell medicine in the Hsinchu Biomedical Science Park, two of the company’s stem cell therapy products have advanced to Phase III clinical trials. The company operates two core facilities in the science park: a Cell Processing Center (CPC) and a PIC/S GMP Cell Therapy Cell Preparation Factory. In preparation for future drug approval and global expansion, Gwo Xi Stem Cell is striving to apply PIC/S GMP certification by the end of October in 2025.
18 Cell Therapy Production Lines with Modular Processes to Offer Flexible CDMO Services
In addition to manufacturing its own pipeline of stem cell therapy products, Gwo Xi Stem Cell operates PIC/S GMP-compliant facility with 18 Cell Processing Units (CPUs) to provide end-to-end Contract Development and Manufacturing Organization (CDMO) services. The adoption of modular processes provides enhanced flexibility for client solutions, covering the entire cell therapy industry chain, including cell banking, cryopreservation, cell expansion, clinical-grade cell QC testing, aseptic filling, and cold-chain logistics. Dr. Po-Cheng Lin, CTO of Gwo Xi Stem Cell, stated: “At Gwo Xi Stem Cell, we uphold rigorous quality standards for cell therapy products. Our stem cell medicines are supported by both domestic and international clinical data, demonstrating their safety and efficacy. Furthermore, we have successfully exported Taiwan-manufactured cell therapy products abroad for conducting clinical trials, establishing a reliable model for international cold-chain delivery.”
Allogeneic Stem Cell Manufacturing with Dual-Track Development and Bioreactor Systems
Gwo Xi Stem Cell’s product pipeline encompasses both autologous and allogeneic cell therapy products to address unmet medical needs. In line with the growing demand for allogeneic therapies, the company has established IRB approved human stem cell banks compliant with the law in Taiwan, named “Human Cell Therapy Product Donor Eligibility Determination Guidelines”. Bioreactor systems have also been introduced to enable large-scale production. Initial validation has demonstrated sufficient capacity to meet clinical demand, with planned scale-up to support broader market needs while reducing production costs.
According to Grand View Research, the global CDMO market reached USD 146 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% from 2024 to 2030, with the Asia-Pacific region accounting for 37.6% of the market share. The rise of advanced medicinal therapies, combined with evolving regulatory frameworks, is expected to drive further growth in the CDMO sector.
In addition to in-house pipeline, the Gwo Xi Stem Cell’s PIC/S GMP Facility operates 18 production lines (CPUs) providing comprehensive CDMO services.
Cell therapy is at the forefront of next-generation medicine, with regulatory advancements worldwide paving the way for transformative breakthroughs in the pharmaceutical industry. Gwo Xi Stem Cell remains committed to the advancement of cell therapy technologies. With a robust pipeline, mature manufacturing platforms, and a comprehensive intellectual property portfolio, the company has secured 115 global patents to date, most of which are invention patents, solidifying its leadership position in Taiwan’s cell therapy industry.