Beijing Vaccine Testing Center Officially Launched with Annual Capacity of Up to 4,500 Batches
On the morning of December 26, the Beijing Vaccine Testing Center was unveiled and officially commenced operations in the Zhongguancun Life Science Park. The center will meet the annual batch release testing demand for 4,000–4,500 batches of vaccines and possess the capacity to conduct batch release testing for new vaccines launched over the next 5–10 years. It is expected to begin undertaking batch release testing for nine authorized Beijing-produced vaccine types in the first quarter of 2026.
The project covers a floor area of 16,000 square meters and was awarded the 2024 Beijing Construction (Great Wall) Structural Excellence Award. It primarily comprises five specialized laboratories—namely, a viral vaccine laboratory, a bacterial vaccine laboratory, an animal laboratory, a microbiology laboratory, and a comprehensive laboratory—along with supporting facilities, covering all inspection items for currently marketed vaccines produced in Beijing. Furthermore, it meets the R&D needs for novel biological drugs, including new vaccines, novel antibody drugs, and cell and gene therapy products, thereby providing full-chain quality control technical support for the innovative R&D of biological products in the city.
As a major national hub for vaccine research, development, and production, Beijing is home to eight vaccine manufacturers, accounting for over 40% of the vaccine varieties in China, with its vaccine production and supply volume ranking first nationwide. In 2022, the Beijing Institute for Drug Control, as one of the four national lot release network laboratories in China, successfully passed the World Health Organization’s (WHO) assessment of the National Regulatory Authority (NRA) system. In 2024, it became the first provincial-level drug testing institution in China to obtain WHO Prequalification (PQ) pre-certification, taking the lead in fully implementing informatization of testing operations. It currently possesses full-item testing capabilities for 28 vaccine varieties, has been authorized by the National Medical Products Administration (NMPA) for lot release of nine vaccines, and maintains the leading position among all provinces in China in terms of lot release testing capacity.
Centered on the construction of Beijing as an international center for scientific and technological innovation, we will leverage platforms such as the Regulatory Science Innovation Research Base and key laboratories to actively engage with R&D institutions. By conducting collaborative research and tackling regulatory science challenges in new drug development, we aim to develop a suite of new methods, tools, and standards, continuously enhance testing capabilities, and accelerate the review and approval process. We will proactively advance automation and intelligence in pharmaceutical testing, upgrade business information systems, and harness AI empowerment to improve intelligent testing and risk prediction capabilities. Furthermore, we will promote the World Health Organization Listed Authority (WLA) assessment for vaccine testing facilities, align quality management with international standards, and facilitate the export of Beijing-manufactured vaccines.
Li Wendong, Deputy Director of the Beijing Institute for Drug Control, stated that the Institute will take the operation of the Vaccine Testing Center as an opportunity to continue adhering to rigorous testing, accelerating turnaround times, expanding the scope of testable varieties, and enhancing technical capabilities. It aims to further strengthen the effectiveness of drug quality and safety testing, comprehensively improve its drug testing capabilities, regulatory science research capacities, and management support levels, thereby effectively serving the high-quality development of the biopharmaceutical industry.