On December 28, 2023, the State Administration for Market Regulation and the National Standardization Administration issued National Standard Announcement No. 20 of 2023. The national standard GB/T 43459-2023 “Technical Specifications for Cell Culture Operations in Clean Rooms and Controlled Environments”, which was developed with the participation of Shenzhen Beike Biotechnology Co., Ltd. in the field of clean rooms and related controlled environments, was officially released. The standard is under the jurisdiction of the SAC/TC 319 Clean Rooms and Related Controlled Environments Standardization Committee and will be implemented on July 1, 2024.
GB/T 43459-2023 “Technical Specifications for Cell Culture Operations in Clean Rooms and Controlled Environments” is applicable to mammalian cell culture in clean rooms and related controlled environments. Specifies the requirements for mammalian cell culture operations in clean rooms and related controlled environments, and describes corresponding verification methods.
The “14th Five-Year Plan” bioeconomy development plan and the “Biosafety Law of the People’s Republic of China” both clearly point out that biosafety should be integrated into the national security system, systematically plan the construction of the national biosafety risk prevention and control and governance system, and comprehensively improve the national biosafety governance capabilities. The construction and design of clean rooms and cell culture operations integrates multiple disciplines such as medicine, physics, chemistry, information management, and “interdisciplinary” disciplines such as building structures, electrical automation, fire safety, and environmental protection. It is extremely complex and specific, and is closely related to biosafety management. Beike Biotech has more than ten years of experience in the industrialization of stem cells and regenerative medicine, and has independently constructed multiple cell preparation centers and cell banks in compliance with high-level biosafety standards, allowing biological experiments to be conducted safely and orderly. At the same time, as an industry leader, Beike Biotech took the lead in drafting and compiling the Shenzhen local standard – “SZDB/Z 188-2016 Construction and Management Specifications for Cell Preparation Centers” in 2016. This is my country’s first local standard for the construction and management of cell preparation centers. Based on Beike Bio’s previous experience in the construction, operation, and management of GMP-level cell preparation laboratories and its experience in standard drafting, Beike Bio was deeply involved in the drafting, research, and formulation of the national standard GB/T 43459-2023 “Technical Specifications for Cell Culture Operations in Clean Rooms and Controlled Environments.”
As a domestic high-tech enterprise specializing in the clinical transformation and technical services of biotherapeutic technologies in strategic emerging industries, participating in the formulation of national standards related to the cell industry is a very important link in the standardization construction of Beike Biotech. Over the years, Beike Biotechnology has always attached great importance to the construction of standardization work in the cell industry, and has never stopped researching and making breakthroughs in related technologies, including laboratory construction management and cell preparation processes. While summarizing and refining successful practical experience, Beike Biotech has actively promoted innovative system construction and technical research results. In the future, Beike Biotech will continue to invest in the standardization construction of the cell industry, actively promote the standardized construction and management of the cell industry, and provide strong support for the high-quality development of biosafety management and laboratory construction in my country.