The government-initiated CRDMO (Contract Research, Development, and Manufacturing Organization) national team—Taiwan Bio-Manufacturing Corporation (TBMC)—announced on the 25th that its GMP facility in Zhubei is expected to be completed by the end of this year. The factory will undergo validation in the first quarter of next year and begin production in the second quarter, with an annual capacity of 13 million mRNA vaccine doses. This supports the government’s “National Security Vaccine Resilience” plan and aims to establish Asia’s most advanced nucleic acid drug manufacturing hub.
At a media briefing held during the Asia Biotech Conference yesterday, TBMC CEO David Chang said that although TBMC’s production scale cannot compete with major international manufacturers, Taiwan’s cost advantages give the company confidence to build a globally rare disease drug production center.
TBMC CTO Wei-Kuang Chi stated that the company has already received contract manufacturing orders from several of the world’s top 10 pharmaceutical companies, renowned U.S. firms, and Japanese biotech companies. These projects include gene therapy, nucleic acid drug products, and biologics CMO services. TBMC’s revenue in the first half of this year has reached 1.8 times the total for 2024, and the number of contracted service projects in the first half is 1.7 times that of the entire 2024. More contracts are expected in the second half of the year.
David Chang explained that construction of the Zhubei GMP factory began in June. The first phase will feature production capabilities for nucleic acid drugs and cell therapies. The nucleic acid drug production line can manufacture approximately 13 million mRNA vaccine doses annually, expandable up to four times in emergencies. The cell therapy section will build automated, closed systems for CAR-T and mesenchymal stem cell manufacturing to provide high-quality process services. By 2027, the second phase aims to complete GMP facilities for gene therapy and biologics, with gene therapy process validation targeted for 2028.
At its inception, TBMC successfully completed a seed funding round led by the National Development Fund (NDF). However, during its second fundraising last year, it did not receive support from government-backed investors. David Chang emphasized that TBMC was established to strengthen Taiwan’s vaccine resilience, especially under President Lai Ching-te’s push for “Taiwan’s vaccine industry resilience and national security and health sustainability.” TBMC is the only domestic company capable of producing mRNA vaccines, with a mission to maintain independent production capability during pandemics. Achieving this requires that the company be financially self-sustaining.
He stressed that the seed funding from the National Development Fund was a crucial starting point enabling collaboration with the U.S.-based Resilience company.
Resource: CRDMO國家隊 新廠將量產 年產1,300萬劑mRNA疫苗
