Taiwan Bio-Manufacturing Corporation (TBMC) held a groundbreaking ceremony on the 26th for its new GMP facility in Zhubei, marking the official launch of the nation’s first GMP-compliant manufacturing base for mRNA nucleic acid drugs and vaccines. The facility is slated for operation in the first half of 2026. Chairman Patrick Y. Yang stated that this represents a key milestone in TBMC’s journey toward becoming a world-class pharmaceutical CDMO.
Yang emphasized that the COVID-19 pandemic underscored the critical role of mRNA technology in combating emerging infectious diseases. TBMC’s mission is to localize the manufacturing capabilities and technologies of advanced global biopharmaceuticals in Taiwan to safeguard public health and national security.
Designed by a renowned U.S.-based team, the Zhubei plant will be built to meet international GMP standards with a highly flexible and modular design, addressing the complex processes and scaling challenges of advanced drug manufacturing. In its initial phase, the facility will focus on mRNA nucleic acid drugs and vaccines, as well as cell therapy production lines. For mRNA products, the plant will support end-to-end production—from upstream plasmid linearization to lipid nanoparticle-encapsulated mRNA—enabling the manufacture of next-generation vaccines and treatments for rare diseases. Initial annual production capacity is projected to reach 13 million doses of mRNA vaccines, strengthening Taiwan’s self-sufficiency in vaccine production and pandemic resilience. On the cell therapy front, the facility will offer manufacturing services for mesenchymal stem cells and CAR-T immune cells, supporting needs across preclinical research, clinical trials, and commercial-scale production.
The GMP facility is expected to be completed by the end of 2025 and operational in the first half of 2026. Meanwhile, construction of the QC laboratory and quality systems is already underway and will be completed in the second half of this year, laying the groundwork for GMP certification and process validation. In the future, TBMC also plans to expand into the large-scale production of gene therapies and complex biologics, broadening its service offerings across the biotech sector.
Even before the plant’s completion, TBMC had already established process development and analytical labs in both Taipei and Zhubei in 2024. These facilities currently serve domestic and international clients in nucleic acid, cell, gene therapy, and biologics development. Upon GMP completion, TBMC will provide an integrated one-stop platform from upstream process development and analytics to downstream manufacturing.
Deputy Director-General Chen Kuo-Liang of the Hsinchu Science Park Administration noted that the Zhubei Biomedical Park has already become a key manufacturing hub for Taiwan’s biotech industry, and the TBMC GMP facility will further enhance the park’s production capabilities.
Board Director of TBMC and Senior Technical Specialist at the Department of Industrial Technology, MOEA, Chien-Cheng Tai, remarked that TBMC will serve as both a pillar of Taiwan’s biomedical industry and a gateway to the global market. The facility is designed to handle small-batch, diversified production as well as large-scale manufacturing. In normal times, TBMC will be a valuable partner to both international pharmaceutical companies and local startups. In times of crisis, it will be able to work with the government to provide urgently needed vaccines and medicines to meet public health demands.
Resource: TBMC打造全臺首座核酸藥物GMP廠 拚2026年上半年啟用
