Facing threats from various emerging infectious diseases worldwide, the proactive development of vaccines and pandemic control measures are the greatest expectations and protective shields for all citizens. However, without the necessary preparations for vaccine development and practical experience in conducting clinical trials during peacetime, trying to produce vaccines immediately when pandemic strikes would be like searching for a needle in a haystack.

The National Institute of Infectious Diseases and Vaccinology of the National Health Research Institutes (NHRI) and its affiliated bioproduction plant have spent many years establishing various cell culture platforms to amplify virus quantities and produce vaccines. They have successfully produced vaccines that meet national pharmaceutical standards, such as enterovirus type 71, new influenza strains H5N1 and H7N9, and conducted clinical trials.

However, this time, the highly contagious novel coronavirus variant falls under biosafety level three (BSL-3) operation due to its pathogenic nature. In practice, it is more challenging to produce vaccines through cell culture methods. This has given rise to the emergence of adenovirus vector vaccines and mRNA vaccines, teaching us a valuable lesson.

Since the outbreak of the pandemic less than two years ago, more than 320 different COVID-19 vaccines have been developed worldwide. Among them, 130 are in clinical trial phases, 39 have entered phase III, and 23 have received emergency use authorizations (EUAs). This represents an unprecedented "light-speed" record in the history of human vaccine development. It underscores the importance of developing diverse vaccine production technologies and establishing emergency production capabilities to proactively respond to future pandemic threats.

After Taiwan experienced the SARS epidemic in 2003, the government constructed a nationally certified GMP pilot bioproduction plant within NHRI. This plant bears the responsibility of national security-level epidemic prevention. In addition to developing essential biopharmaceuticals that have low domestic demand and are not attractive to private companies, NHRI conducts various drills and technology platform development for national security vaccine production during peacetime to fight diseases during emergencies.

Since its operation in 2008, the bioproduction plant has developed several human vaccine technologies in response to Taiwan's epidemic needs. It plays a crucial role in translating research outcomes into industrial applications. Notably, the enterovirus type 71 vaccine has guided technology transfer companies through phase III clinical trials and is currently undergoing drug certification application, marking a significant milestone in Taiwan's self-developed vaccine production. NHRI also continues to collaborate with the Ministry of Health and Welfare (MOHW) Taiwan Centers for Disease Control (CDC) to supply the needed BCG vaccine and four types of antivenom serum for the Taiwanese population.

The COVID-19 pandemic has swept the world like a whirlwind and continues to mutate, causing significant economic and social losses in various countries. As the only mission-oriented medical and health research institution in Taiwan, NHRI, to protect the health and safety of all citizens, has mobilized efforts to develop and assist domestic businesses in the production of pandemic-related rapid screening test kits, vaccines, and medications. The bioproduction plant and its affiliated biosafety level three (ABSL-3) laboratories play crucial roles but face challenges due to inadequate infrastructure.

To strengthen the domestic capacity for rapid vaccine development and production, NHRI restarted the planning of the Bioproduction Plant 2 in 2020. Under the direction of former minister of MOHW Shih-Chung Chen, a new national-level Infectious Diseases Bank project was devised. Subsequently, with support from various government agencies and efforts by NHRI Director Kung-Yee Liang, the construction project was approved by the National Development Council in April of this year. During this period, a generous entrepreneur donated NT$2 billion unconditionally, and the public and private sectors have joined forces to enhance the nation's epidemic prevention capabilities.

Bioproduction Plant 2 will build six production lines, along with the construction of two ABSL-3 laboratories and an Infectious Diseases Bank. These six production lines will operate independently, with four of them dedicated to large-scale production to increase output in response to the demands of front-line epidemic prevention personnel during emergencies. The remaining two production lines will be used for small-scale production of innovative products for clinical trials, focusing on the development of nucleic acid (DNA, mRNA), viral vector, recombinant protein, and inactivated whole-virus vaccine-related technology platforms.

By collecting various pathogens and specimens through the Infectious Diseases Bank, a "modular" standard vaccine development process will be established. Additionally, since many pathogens of urgent infectious diseases fall under biosafety level three, based on the regulations and personnel safety, in the construction of Bioproduction Plant 2, BSL-3 and ABSL-3 laboratories will be built together, which is a crucial part of this project.

Upon completion of Bioproduction Plant 2, it will be aimed at enhancing national security by complementing the Epidemic Prevention Center of the Taiwan Centers for Disease Control (CDC), and integrate tasks related to epidemic prevention and vaccine development. In addition to aligning with the government's vaccine development policies and meeting the needs of Taiwanese population, it will undertake the development of novel platform technologies with low commercial value or difficulty attracting private investment. Simultaneously, optimization will be carried out for the production processes of the BCG vaccine and antivenom serum, to improve product quality and supply stability.

On the vaccine industry chain, it will play a crucial bridging role between upstream academic research and downstream industrial productization. Assisting the industry with the ability of process development, collaborating with the industry to enhance the Taiwan's self-production capability of biopharmaceuticals.