On March 5, 2019, Medigen Vaccine Biologics Corp. (MVC, TPEX 6547), Medigen Biotechnology Corp. (Medigen, TPEX 3176), and Taiwan Bio Therapeutics Inc. (Taiwan Bio) signed a strategic alliance agreement, centered on MVC's newly established cell processing center (CPC)—the largest and highest-standard facility in Taiwan. The alliance combines Medigen's expertise in immune cell therapy with Taiwan Bio's stem cell therapy technology. Together, the three companies will adhere to the stringent PIC/S GMP production framework, enhance cell expansion and manufacturing capabilities, collaborate on R&D, and share marketing resources and commercial benefits. 

With the enactment of the Regulation Governing the Application of Specific Medical Examination Technique and Medical Device (“Regulations of Special Medical Techniques”) in 2018, and the ongoing legislative review of the Regenerative Medicinal Products Act  in Taiwan's Legislative Yuan, Taiwan has become the second country after Japan to implement specialized laws for regulating regenerative medicine technologies and products. The rapid growth of the cell therapy market is driving strong demand for high-standard production facilities. Historically, Taiwan's cell therapy industry was limited by regulatory restrictions, with only a few hospitals and biotech companies operating small-scale GTP laboratories. Following regulatory reforms, manufacturers are now required to comply with strict aseptic manufacturing standards, making the adoption of GMP-level CPCs the key differentiator for future industry leaders. 

MVC, a leader in cell-culture-based vaccine manufacturing and aseptic production, has already obtained PIC/S GMP certification for its vaccine facilities. Anticipating the synergy between vaccine manufacturing and cell therapy production, MVC has constructed Taiwan's largest and highest-grade CPC in the Hsinchu Biomedical Science Park.  Positioned as a CDMO, the CPC will provide process development and manufacturing services to cell therapy developers. In addition to its strategic partners Medigen and Taiwan Bio, MVC is also in discussions with other cell therapy companies to foster a nationwide alliance leveraging Taiwan's biotech strengths to accelerate the growth of the cell therapy industry. 

This tripartite alliance not only capitalizes on the significant market opportunities following the enactment of the Regulations of Special Medical Techniques but also marks a key transition of the cell therapy sector in Taiwan from GTP-level laboratory practices to GMP-level industrial standards. Through MVC's expertise in aseptic GMP manufacturing and CDMO services, Medigen and Taiwan Bio will strengthen process validation and quality systems to provide safer and more consistent cell therapy products, ultimately benefiting patients while elevating Taiwan's biotech industry. 

Medigen Vaccine Biologics Corp. – Cell Processing Center (CPC) 

MVC's CPC facility is designed in compliance with the latest EMA ATMP GMP requirements (EudraLex Vol. 4 Part IV, GMP requirements for Advanced Therapy Medicinal Products) and meets PIC/S GMP PE 009-14 as well as GTP standards. The production environment is classified as Grade B/C, exceeding the ISO 14644-1 and FS-209E Class 10,000 cleanroom standards common in GTP laboratories. Each independent cell processing unit (CPU) operates as a closed system and is suitable for various cell manufacturing processes. Leveraging MVC's extensive experience in cell culture processes and aseptic preparation GMP inspections, the company also offers Quality by Design quality systems (QS), including process validation services to establish Critical Process Parameters (CPP) and Critical Quality Attributes (CQA). 

Medigen Biotechnology Corp. – Immune Cells 

Medigen is a market leader in immune cell therapy technologies in Taiwan, with cancer treatment as its primary focus. Its autologous natural killer (NK) cell therapy, Magicell-NK, for treating malignant solid tumors, has been submitted in collaboration with Yong Chang Shin Clinic, E-Da Hospital, and Hualien Tzu Chi Hospital, and will be applied clinically upon regulatory approval. Additional clinical trials are also in planning and will be rolled out progressively. 

Taiwan Bio Therapeutics Inc. – Stem Cells 

Taiwan Bio specializes in the development of mesenchymal stem cell (MSC) isolation and expansion technologies. Its low-oxygen, low-density cultured MSCs possess high differentiation potential. The company's initial therapeutic targets are osteoarthritis (OA) and peripheral arterial occlusive diseases. Its allogeneic bone marrow–derived MSCs for knee OA treatment are in Phase I/IIa clinical trials, and plans for autologous MSC applications are underway in collaboration with major hospitals in Taiwan, with submissions to the MOHW under the Regulations of Special Medical Techniques.