On December 28, 2023, the State Administration for Market Regulation and the Standardization Administration of China issued National Standard Announcement No. 20 of 2023. The national standard in the field of cleanrooms and associated controlled environments — GB/T 43459-2023 "Technical Specification for Cell Culture Operations in Cleanrooms and Controlled Environments" — co-developed with Shenzhen Beike Biotechnology Co., Ltd., was officially released. The standard falls under the purview of SAC/TC 319, the National Technical Committee on Cleanrooms and Associated Controlled Environments, and will take effect on July 1, 2024.
GB/T 43459-2023 "Technical Specification for Cell Culture Operations in Cleanrooms and Controlled Environments" applies to mammalian cell culture in cleanrooms and associated controlled environments. It sets out requirements for mammalian cell culture operations in cleanrooms and associated controlled environments and describes the corresponding verification methods.
The 14th Five-Year Plan for the Bioeconomy and the Biosecurity Law of the People's Republic of China make clear that biosecurity is to be incorporated into the national security system, with systematic planning of the building of national biosecurity risk prevention, control, and governance systems, and a comprehensive raising of national biosecurity governance capacity. The construction and design of cleanrooms and cell culture operations integrate multiple disciplines — medicine, physics, chemistry, information management — and multiple specialties, including building structures, electrical and automatic control, fire safety, and environmental protection. They are intensely complex and specialized "interdisciplinary disciplines", and are also closely tied to biosecurity management. With more than ten years of industrialization experience in stem cells and regenerative medicine, Beike Biotech has independently built multiple cell preparation centers and cell banks in compliance with high-level biosafety standards, ensuring that biological experimental work is carried out safely and in an orderly manner. As a leader in the industry, in 2016 Beike Biotech also led the drafting of the Shenzhen local standard SZDB/Z 188-2016 "Specification for the Construction and Management of Cell Preparation Centers" — the first local standard in China for the construction and management of cell preparation centers. Building on its prior experience in the construction, operation, and management of GMP-grade cell preparation laboratories and in standard drafting, Beike Biotech was deeply involved in drafting, researching, and developing the national standard GB/T 43459-2023 "Technical Specification for Cell Culture Operations in Cleanrooms and Controlled Environments".
As a national high-tech enterprise specializing in the clinical translation of biotherapy technologies in strategic emerging industries and in technical services, participation in the development of national standards related to the cell industry is an extremely important part of Beike Biotech's standardization work. Over the years, Beike Biotech has consistently attached great importance to the standardization of the cell industry and has never stopped researching and innovating in technologies including laboratory construction and management and cell preparation processes. While distilling and consolidating successful practical experience, the company has actively translated its innovative system-building and technology research outcomes into broader application. Going forward, Beike Biotech will continue to invest in cell industry standardization, actively promote standardized construction and management of the cell industry, and provide strong support for high-quality development of biosecurity management and laboratory construction in China.
