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2025/02/17
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GWOXI Stem Cell's PIC/S GMP-compliant manufacturing facility is racing to be completed in October, fully accelerating its ov
文章引用自:Commercial Times
國璽幹細胞 PIC/S GMP藥廠位於新竹生醫園區。
GWOXI Stem Cell's PIC/S GMP pharmaceutical facility is located in the Hsinchu Biomedical Science Park.

 

GWOXI's PIC/S GMP Cell Manufacturing Facility is scheduled to receive its certification in October.

GWOXI Stem Cell Corp. has recently achieved numerous breakthroughs, with two of its stem cell therapy products now in Phase III clinical trials. It is the first company focused on stem cell therapy technology R&D within the Hsinchu Biomedical Science Park, where it operates two core facilities: a Cell Processing Center (CPC) and a PIC/S GMP cell manufacturing facility (GMP Facility). To prepare for future drug approvals and global expansion, the company is racing to obtain PIC/S GMP certification before the end of October.

Integrating modular processes across 18 cell product production lines, we provide highly flexible CDMO services.

GWOXI's PIC/S GMP cell manufacturing facility not only produces its own cell therapy products but also offers comprehensive Contract Development and Manufacturing Organization (CDMO) services through its 18 production lines (Cell Processing Units, CPUs). These production lines incorporate a modular process, providing customers with flexible and diverse options while integrating upstream, midstream, and downstream services across the industry chain. These services include cell bank establishment, cell storage, cell culture and expansion, clinical cell preparation testing, aseptic filling, and cold chain logistics.

GWOXI CTO Lin Po-cheng stated: "GWOXI holds stringent quality standards for cell preparations. Our developed stem cell drugs are supported by clinical trial data from both Taiwan and abroad, which validates their safety and efficacy. Furthermore, we have successfully transported cell preparations manufactured in Taiwan to overseas locations for cell therapy and completed the clinical trial closings, successfully establishing an international cold chain logistics model."

Autologous and allogeneic stem cell production lines are operating in parallel with the integration of bioreactors.

GWOXI's Strategic Focus on Allogeneic Cells
GWOXI's new drugs under development include both autologous and allogeneic cells to meet the specific needs of different indications. In response to the trend toward allogeneic cells, GWOXI has built a Master Cell Bank, a Working Cell Bank, and a Bio-resource Sharing Bank. Its cell sources comply with the "Criteria for Suitability Assessment of Human Cell Therapy Product Donors." Concurrently, it is integrating bioreactors for large-scale production. The initial phase has been fully validated and can meet the volume required for clinical needs. In the future, production will be gradually scaled up to meet market demand while also lowering production costs.

Global CDMO Market Trends
According to a report by Grand View Research, the global CDMO market was valued at $146 billion in 2023, with a Compound Annual Growth Rate (CAGR) of 7.2% from 2024-2030. The Asia-Pacific market accounts for 37.6% of this total. The rise of emerging therapies and the gradual improvement of regulations in various countries will inject more momentum into the CDMO market.

 

國璽 PIC/ S GMP細胞製劑藥廠除了生產自行開發之細胞治療產品外,共有 18 條生產線 (CPU) 提供全方位的 CDMO 服務。
In addition to producing its own cell therapy products, GWOXI's PIC/S GMP cell manufacturing facility offers comprehensive CDMO services through its 18 production lines (CPUs).

 

The cell therapy industry is a key focus for emerging medical fields. As regulations are liberalized in various countries, it is poised to bring a revolutionary impact to the pharmaceutical industry. GWOXI is committed to developing cell therapy technologies, boasting a rich product pipeline, a mature manufacturing platform, and a comprehensive intellectual property strategy. To date, the company has secured 115 patents globally, the majority of which are invention patents, establishing it as a leader in Taiwan's cell therapy industry.