2026年3月27日

TBMC Opens GMP Facility in Zhubei, Marking a New Milestone in Advanced Biomanufacturing

Taiwan Bio-Manufacturing Corporation (TBMC) today held the opening ceremony of its GMP facility in Zhubei, located at the Hsinchu Biomedical Science Park. The facility is Taiwan’s first GMP site equipped with mRNA manufacturing capabilities, marking a significant milestone for the country’s biopharmaceutical industry as it enters a new era of advanced biomanufacturing. The opening also signals a new phase in TBMC’s CRDMO service development.

Amid the rapid evolution of the global biopharmaceutical industry, TBMC is expanding into diversified advanced therapeutic manufacturing to enhance its international competitiveness.

Chairman Patrick Yang stated that TBMC’s vision is not only to build a manufacturing facility, but to establish a world-class biopharmaceutical CRDMO platform. Guided by its core values of innovation, integrity, courage, discipline, and teamwork, TBMC believes that true success lies in the disciplined execution of six key pillars: customer first, global reach, responsive leadership, uncompromising quality, accountable execution, and technology-driven innovation. Through these principles, TBMC serves as a critical bridge between innovative R&D and commercial production, accelerating the translation of biopharmaceutical innovations into market-ready products.

Former Vice President of Taiwan and Academician, Academia Sinica, Chen Chien‑Jen, remarked that the newly inaugurated facility will serve as Taiwan’s first GMP site dedicated to nucleic acid-based therapeutics.

He noted that the facility will not only support large-scale vaccine production during public health emergencies, but also provide diversified contract manufacturing services for biopharmaceutical products. As global biopharmaceutical technologies continue to advance—from vaccines and nucleic acid therapeutics to cell and gene therapies—building internationally competitive manufacturing capabilities and a complete industry ecosystem will be critical to Taiwan’s future development.

The opening ceremony was marked by a ribbon-cutting led by Chairman Patrick Yang and CEO David Chang, alongside Academician Chen Chien-Jen, joined by distinguished guests from government, industry, academia, and research sectors. More than 80 attendees were present to witness this milestone, underscoring a significant step forward in Taiwan’s advanced biopharmaceutical manufacturing capabilities.

Phase I of the Zhubei GMP facility was completed in approximately 18 months from design to operation, a relatively short timeline by international standards.

CEO David Chang noted that, as demand for integrated R&D services and flexible manufacturing grows, TBMC has established an agile manufacturing facility capable of scaling production while precisely meeting customer needs.

Through a flexible “small-volume, high-mix” production model, the facility supports the rapid progression of products from early-stage research and process development to clinical trials and commercial manufacturing.

Advanced Therapy Manufacturing Capabilities

The Zhubei GMP facility is designed to support advanced therapeutic modalities. Phase I includes manufacturing capabilities for:

  • mRNA and nucleic acid-based therapeutics
  • CAR-T and mesenchymal stem cell (MSC) therapies
  • viral vectors and biologics

Annual capacity includes:

  • approximately 480 patients for autologous CAR-T therapies
  • around 100 batches of allogeneic MSC therapies
  • up to approximately 13 million doses of mRNA vaccines or related products
  • flexible allocation of up to 200 L capacity for viral vectors or biologics

Integrated Quality Control Laboratory

To support advanced therapy manufacturing and quality requirements, TBMC has established an approximately 1,300-square-meter Quality Control (QC) laboratory.

The facility is among the few in Taiwan equipped with testing capabilities across nucleic acids, cell therapies, viral vectors, and biologics. In addition to supporting internal quality control and environmental monitoring, the QC laboratory also provides outsourced analytical services, including product testing and stability studies, to help clients meet regulatory requirements and ensure product quality.

TBMC continues to strengthen its global market presence. The presence of its long-term partner, CBC Group (Japan), at the opening ceremony reflects the strong and ongoing collaboration between the two parties.

With the official launch of the Zhubei GMP facility, TBMC will further enhance its one-stop manufacturing platform and global service capabilities, marking a new milestone in its development as an international CRDMO for advanced biopharmaceuticals.

TBMC held the opening of its GMP Zhubei facility. Chairman Patrick Yang (4th from right) and CEO David Chang (2nd from left) joined former Vice President and Academia Sinica Academician Chen Chien-Jen (4th from left), Tsung Tsong Wu (3rd from left), Chairman of ITRI; Mei Hua Wang (3rd from right), Independent Director of Taishin Shin Kong Financial Holdings; Ting An Wang (2nd from right), Executive Secretary of the National Development Fund; Shi Min Hu (1st from left), Director General of the Hsinchu Science Park Bureau; and Takashi Nakano (1st from right), Group Manager, Life Science Division, CBC Co., Ltd. (Japan) for the ribbon-cutting ceremony.