Taiwan Bio-Manufacturing Corporation (TBMC) held a groundbreaking ceremony today (26th) at Hsinchu Biomedical Science Park, officially initiating the construction of Taiwan’s first GMP manufacturing base for mRNA nucleic acid medicines and vaccines. This marks a significant milestone in TBMC’s expansion into the global CRDMO (Contract Research, Development, and Manufacturing Organization) market for biopharmaceuticals.

At the opening of the ceremony, Chairman Patrick Yang stated:
“The COVID-19 pandemic has highlighted the crucial role of mRNA technology in preventing and treating emerging infectious diseases. TBMC’s mission is to bring world-class manufacturing capabilities and technologies for cutting-edge medicines to Taiwan, safeguarding public health and national security. The launch of our GMP facility not only demonstrates our production capacity and quality control capabilities, but also represents a key milestone in TBMC’s journey toward becoming a world-class pharmaceutical CRDMO.”

The GMP facility is designed by a renowned U.S. team and built in compliance with international GMP standards. Featuring a highly flexible and modular design, it can accommodate complex advanced drug processes and future scale-up requirements. The initial phase will focus on mRNA nucleic acid medicines and vaccines as well as cell therapy production lines.

For mRNA nucleic acid medicines, the facility will cover the entire upstream process from plasmid linearization to lipid nanoparticle-encapsulated mRNA production, supporting emerging vaccines and rare disease therapies. The initial annual production capacity is expected to reach 13 million doses of mRNA vaccines, strengthening Taiwan’s domestic vaccine production capability and national pandemic resilience.

For cell therapy, the facility will provide manufacturing services for mesenchymal stem cells, CAR-T, and other immune cells, supporting preclinical studies, clinical trials, and commercial-scale production.

The GMP facility is scheduled for completion by the end of 2025 and is expected to commence operations in the first half of 2026. The QC laboratory and quality systems, which are already under construction, will be completed later this year to support subsequent GMP validation and process verification. TBMC also plans to expand production to gene therapies and complex biologics, broadening its overall service portfolio.

Prior to the new facility, TBMC had already established process and analytical services laboratories in Taipei and Hsinchu Biomedical Science Park in 2024, providing services for domestic and international clients in nucleic acid, cell, gene therapy, and biologics. Upon completion of the GMP facility, TBMC will offer a fully integrated, end-to-end platform covering upstream process development, analytical services, and downstream manufacturing.

Future Outlook
TBMC will relentlessly build a world-class global CRDMO platform, accelerating the transformation of innovative therapies from the laboratory to the commercial market, elevating Taiwan’s biopharmaceutical manufacturing capabilities, and forging stronger links with the global biomedical industry.