On March 25, the Hebei Provincial Administration for Market Regulation issued a notice, “Cell Preparation Center Construction and Management Specifications” (No.: DB13/T5162-2020) and “Comprehensive Cell Bank Construction and Management Specifications” (No.: DB13/T5163-2020) were officially approved for release and will be officially implemented on April 25. The two standards are one of the important components of the construction of the standardization system in Hebei Province. They are composed ofOrganized by the Hebei Provincial Market Supervision and Administration Bureau, proposed by the Hebei Provincial Development and Reform Commission, Hebei Beike Biotechnology Co., Ltd., Shenzhen Beike Biotechnology Co., Ltd., and the National and Local Joint Engineering Laboratory for Personalized Cell Therapy Technology (Shenzhen) jointly prepared it.
“Cell Preparation Center Construction and Management Specifications” standardizes the overall requirements for the construction of regional cell preparation centers and clarifies a unified and standardized cell preparation laboratory setup, construction and management system for the construction of regional cell centers in terms of construction requirements, center settings, personnel qualifications, instrument and equipment configuration, consumables, and process flows.
“Comprehensive Cell Bank Construction and Management Specifications” clarifies the setting and management requirements for human living cell sample banks and information data platforms. It covers three aspects: organizational setup requirements, construction requirements, and management requirements, involving equipment and facilities, information platforms, sample libraries, safety management, ethical review and other cell bank setup and management related contents.
As “living” biological products, cell product quality is not only the lifeline of an enterprise, but also the lifeline of the entire cell therapy technology industry. Small deviations in the cell preparation process will have a large impact on the quality of the final product, affecting the safety and effectiveness of clinical applications. The introduction of these two cell industry standardization specifications has a significant impact onHebei Province unifies and standardizes the construction and management system of cell preparation laboratories, improves the quality level of cells and other related biological products, establishes a standardized human living cell sample bank, comprehensively utilizes cell resources, improves the quality management level and application efficiency of cell biological resources, promotes the transformation of international cutting-edge technology personalized cell therapy into a healthy and orderly industry in the province, and provides reference experience for the development of my country’s strategic emerging industries in establishing models and platforms. It is of great significance.
For a long time, the Hebei Provincial Government has always adhered to the implementation of the quality-strengthening province and standardization strategy. The province has built around the construction of a large-quality, large-standard pattern, “strengthening local standard management and promoting the internationalization of standards”, and guiding Hebei standards to go abroad and introduce them. As a leader in the industry, 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 cell preparation centers. It is based on the previous experience in standardization construction that the formulation of this specification, with the strong support and guidance of the Hebei Provincial Development and Reform Commission and the Hebei Provincial Market Supervision and Administration Bureau, combined with the current situation and overall plan of the development of the cell industry in Hebei Province, Beike Biotech will promote the “Shenzhen Standard” to the formulation of Hebei local standards. Responsible for the drafting of these two specifications, is the high recognition of Beike Biotech’s standardization efforts in the field of cell therapy by Hebei Provincial Government departments and industry experts. It also marks another solid step in the infrastructure construction of the new infrastructure of the cell industry – “1 bank, 1 center and 1 platform” (comprehensive cell bank + regional cell intelligent manufacturing center + national network of cell quality testing platform).