On 25 March, the Hebei Provincial Administration for Market Regulation issued a notice that the "Code for the Construction and Management of Cell Preparation Centers" (No. DB13/T5162-2020) and the "Code for the Construction and Management of Comprehensive Cell Banks" (No. DB13/T5163-2020) had been officially approved and released, and would come into force on 25 April. The two standards are an important component of Hebei Province's standardization system. They were organized by the Hebei Provincial Administration for Market Regulation, proposed by the Hebei Development and Reform Commission, and jointly drafted by Hebei Beike Biotechnology Co., Ltd., Shenzhen Beike Biotechnology Co., Ltd. and the National-Local Joint Engineering Laboratory for Personalized Cell Therapy Technology (Shenzhen).
The "Code for the Construction and Management of Cell Preparation Centers" sets out the overall requirements for the construction of regional cell preparation centers and clarifies a unified, standardized cell preparation laboratory establishment, construction and management system covering construction requirements, center setup, personnel qualifications, instrument and equipment configuration, consumables and process flow.
The "Code for the Construction and Management of Comprehensive Cell Banks" sets out the establishment and management requirements for live human cell sample banks and information data platforms. It covers three areas – organizational setup, construction requirements and management requirements – addressing equipment and facilities, information platforms, sample banks, safety management and ethics review and other content related to the establishment and management of cell banks.
As "living" biological products, the quality of cell products is not only the lifeblood of an enterprise but also of the entire cell therapy industry. Even small deviations during cell preparation can have a big impact on the final product quality, in turn affecting the safety and efficacy of clinical application. The release of these two cell-industry standardization codes is of important significance for unifying and standardizing the establishment, construction and management system of cell preparation laboratories in Hebei Province, raising the quality level of cell-related biological products, building standardized live human cell sample banks, comprehensively utilizing cell resources, raising the quality management level and application efficiency of cell biological resources, advancing the healthy and orderly translation of internationally frontier personalized cell therapy in the province, and providing reference experience for building a model and platform for the development of strategic emerging industries in China.
The Hebei provincial government has consistently pursued the strategy of building a quality-driven province and standardization, with the entire province building around the framework of "great quality and great standards" and focusing on both "strengthening local standards management and advancing the internationalization of standards" – guiding Hebei standards to "go out" and bring in. As a sector leader, Beike Biotech took the lead in 2016 in drafting the Shenzhen local standard "SZDB/Z 188-2016 Code for the Construction and Management of Cell Preparation Centers", China's first local standard for cell preparation centers. Building on this previous standardization experience, with the strong support and guidance of the Hebei Development and Reform Commission and the Hebei Provincial Administration for Market Regulation, and combining the current state and overall planning of the cell industry in Hebei Province, Beike Biotech has applied "Shenzhen Standards" experience to the formulation of Hebei local standards. Undertaking the drafting of these two codes is a strong endorsement of Beike Biotech's standardization work in cell therapy by Hebei provincial regulators and industry experts. It also marks another solid step forward in building the new infrastructure of the cell industry – the "1 bank, 1 center, 1 platform" (Comprehensive Cell Bank + Regional Cell Intelligent-Manufacturing Center + national network of Cell Quality Inspection Platforms).
Beike Biotech standardization milestones
