Gwo Xi Stem Cell Files Drug Master File (DMF) with FDA, Integrating into the Global Regenerative Medicine Industry Chain
Gwo Xi Stem Cell’s PIC/S GMP Cell Preparation Factory, located at the Hsinchu Biomedical Science Park in Taiwan, features manufacturing and quality control that meet international standards, serving as a critical foundation for the adipose-derived mesenchymal stem cell (ADSC) starting material bank's successful USFDA DMF registration. (Image courtesy of Gwo Xi Stem Cell)
Gwo Xi Stem Cell (TPEx: 6704) announced that its established Adipose-Derived Mesenchymal Stem Cell (ADSC) Starting Material Bank has been successfully filed Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA). This move strategically deepens and broadens Gwo Xi's presence within the regenerative medicine industry chain by establishing a product of international quality for critical cell raw materials used in drug manufacturing. This not only assists clients with essential traceability control of pharmaceutical raw materials but also accelerates their timeline for regenerative medicine product development.
The DMF is a crucial system established by the FDA for the control of drug safety and quality, and its credibility is widely recognized by the global pharmaceutical industry chain. The data submitted for Gwo Xi’s ADSC starting material bank fully covers cell sourcing (including donor eligibility and infectious pathogen testing), manufacturing facilities, process development, specification setting, inspection methods, product quality, and stability data. It is also supported by comprehensive experience in new drug development. This DMF registration ensures that both the material quality and process data comply with international regulations, enabling downstream users to directly reference the documentation during submissions for clinical trials or new drug approval, thereby expediting the review time and offering a significant benefit to developers in the regenerative medicine sector.
Gwo Xi Stem Cell’s ADSC starting material bank has demonstrated favorable safety profiles, immunomodulatory capabilities, and repair-promoting functions during its application in human clinical trials for new drug development, confirming its position as one of the most promising raw materials in regenerative medicine. Its applications extend beyond cell therapies for conditions like osteoarthritis and autoimmune diseases; it also serves as a vital starting material for the production of increasingly popular exosomes which are extensively utilized in anti-inflammatory, repair, and medical aesthetics fields. Furthermore, ADSC possess a natural tropism for pathological lesions, making them suitable as drug carriers for the further development of anti-cancer, anti-fibrotic, and gene therapy platforms using engineered technology. According to PubMed statistics from the National Center for Biotechnology Information (NCBI) database, there are over ten thousand research articles utilizing mesenchymal stem cell as a starting material for cell therapy and exosome production, highlighting their massive commercial potential in the development of next-generation regenerative medicine products.
The ADSC starting material bank established by Gwo Xi Stem Cell is currently utilized in two clinical trials: a cell therapy clinical trial for knee osteoarthritis (OA) and a cell therapy clinical trial for diabetes (T1DM). Both trials have confirmed the preliminary safety and feasibility of its clinical application. Additionally, Gwo Xi Stem Cell has already secured the International Nomenclature of Cosmetic Ingredients (INCI) certification for the exosomes produced from this material. In its CDMO services, Gwo Xi Stem Cell leverages this established ADSC starting material bank to successfully overcome clients R&D barriers, assisting them in accelerating their regenerative medicine product development, clinical translation, and commercialization progression.
The ADSC starting material bank established by Gwo Xi Stem Cell features complete traceability management, stringent donor screening procedures, and international cold chain transport protocols. This core asset, with USFDA DMF, supports clinical trials, exosome manufacturing, and regenerative medicine product development. (Image courtesy of Gwo Xi Stem Cell)