TBMC Opens GMP Facility in Zhubei, Taiwan for Cell, Gene, and mRNA Manufacturing

Key Points

• TBMC has opened a GMP facility in Zhubei with mRNA manufacturing capabilities, which the company describes as Taiwan’s first GMP site for this type of production.
• The Phase I facility supports mRNA and nucleic acid therapeutics, CAR-T, mesenchymal stem cell (MSC) therapies, viral vectors, and biologics.
• TBMC says the site expands its CRDMO services with small-volume, high-mix manufacturing and an integrated QC lab for testing and stability studies.

Facility Opening and Manufacturing Scope

Taiwan Bio-Manufacturing Corporation (TBMC) has opened its GMP facility in Zhubei at the Hsinchu Biomedical Science Park. The company says the site is Taiwan’s first GMP facility equipped with mRNA manufacturing capabilities. TBMC says the opening marks a new phase in its CRDMO service development and supports its expansion into advanced therapeutic manufacturing.

Former Vice President of Taiwan and Academician, Academia Sinica, Chen Chien‑Jen, said the facility will serve as Taiwan’s first GMP site dedicated to nucleic acid-based therapeutics, and it could support large-scale vaccine production during public health emergencies and provide contract manufacturing services for biopharmaceuticals.

TBMC completed Phase I of the Zhubei GMP facility in about 18 months from design to operation.

Advanced Therapy Capacity

Phase I of the facility includes manufacturing capabilities for:

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

TBMC says annual capacity includes:

• approximately 480 patients for autologous (sourced from the patient) CAR-T therapies
• around 100 batches of allogeneic (donor-derived) 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

The company says the facility uses a small-volume, high-mix production model to support products from early-stage research and process development through clinical trials and commercial manufacturing.

Quality Control and Service Expansion

TBMC has also established an approximately 1,300-square-meter quality control laboratory to support manufacturing and quality requirements across advanced therapy modalities. The company says the lab is among the few in Taiwan with testing capabilities spanning nucleic acids, cell therapies, viral vectors, and biologics.

In addition to internal quality control and environmental monitoring, the QC laboratory provides outsourced analytical services, including product testing and stability studies, to support regulatory requirements and product quality.

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