Taiwan’s first GMP-grade viral vector production plant, TFBS Bioscience’s new factory in Zhubei, officially opened yesterday. Minister of Economic Affairs Kuo Jyh-huei attended the ceremony, stating that this event marks Taiwan's advancement in cell and gene therapy manufacturing capacity, moving from clinical trial-scale production to commercial-scale output.
During his remarks, Kuo shared off-script insights, mentioning that the U.S. Biosafety Law prohibits outsourcing to China, which could lead to a transfer of orders to Taiwan. However, TFBS Chairman Nguyen Da-tong noted that the strictness of the biosafety law's implementation will depend on the U.S., and while Taiwan is hopeful, it may take a year for the full impact to be realized. He emphasized that this presents an opportunity for Taiwan's CDMO (Contract Development and Manufacturing Organization) industry.
Kuo noted that Taiwan’s current average life expectancy is around 80 years, with biotechnology research and innovation crucial to the population’s health. He referenced President Tsai’s “Healthy Taiwan” initiative and highlighted that the Ministry of Economic Affairs is dedicated to advancing the biotech industry with this goal in mind.
Kuo elaborated that Taiwan’s biotech and medical industry generated NT$750 billion in revenue last year. The Economic Ministry has extended the Biotech and Pharmaceutical Development Act to 120 years, providing R&D tax incentives to encourage industry investment in regenerative and precision medicine.
He emphasized that future policy will also encourage the expanded application of AI in pharmaceuticals, medical devices, and digital healthcare, aiming to propel the biotech and medical sector into a trillion-dollar industry. The inauguration of TFBS’s new facility is expected to create further opportunities, with the Ministry continuing to support industry development and strengthen international partnerships.
TFBS Bioscience was initially derived from the Ministry of Economic Affairs’ Development Center for Biotechnology (DCB) and originated as the Center for Biologics Testing, specifically established to support Taiwan’s biotech R&D and manufacturing sectors. Years ago, TFBS established Taiwan's only biopharmaceutical safety testing laboratory, certified under GLP standards by TFDA and OECD. TFBS formally spun off from DCB in 2016.
In 2019, TFBS expanded into the CDMO business for viral vectors, setting up a pilot plant in Xizhi. In 2023, it formed a regenerative medicine supply chain partnership with Japan’s Teijin Group and Mediridge, targeting the Japanese market.
TFBS also established a process development lab in Chiba, Japan, to serve Japanese clients. In October 2024, it formed a strategic partnership with Minaris Regenerative Medicine for North America, focusing on cell and gene therapy services.
At the Zhubei facility's inauguration, TFBS invited 24 prominent experts from Japan’s cell and gene therapy sector. Notable attendees included Professor Koji Tamada from Yamaguchi University, Professor Takashi Kojima from the Japanese National Cancer Center, Professor Keizo Tomonaga from Kyoto University, Dr. Masato Nakanishi, President of Tokiwa-Bio, and John Yu, Distinguished Chair Professor and Director at Chang Gung University. TFBS’s Japanese and North American alliance partners, including Teijin Group’s TEIJIN REGENET, Mediridge, and Minaris Regenerative Medicine, were also represented by their senior management at the event.
Resource (mandarin): 啟弘新廠啟用 郭智輝：美生物安全法禁陸、台廠將迎轉單
