[Shenzhen Commercial Daily News] (reporter Wang Hairong) A new member has joined Shenzhen's standards system. The "Code for the Construction and Management of Cell Preparation Centers" (No. SZDB/Z 188-2016), organized by the Shenzhen Municipal Market Supervision Administration in conjunction with the Shenzhen Development and Reform Commission and jointly drafted by Shenzhen Beike Biotechnology Co., Ltd. and the Shenzhen Institute of Standards and Technology, was recently officially approved and released, and was implemented in early July. The release of this code helps standardize the construction and management of cell preparation centers and drives the sustainable, healthy development of China's cell therapy industry.
In recent years, Shenzhen has adhered to innovation-driven, quality-led development. Building on its "Shenzhen Quality" strategy, the city has put forward the development concept of "creating Shenzhen Standards to build new advantages for quality development", and has encouraged leading enterprises to formulate standards in their respective fields. The release of this code is seen as the latest step in the Shenzhen biotechnology industry's drive to lead in standards.
In an interview yesterday with Beike Biotech, one of the standard's drafters, the reporter learned that the absence of a standards system has become a bottleneck holding back the development of China's cell therapy industry. At the same time, the large number of cell preparation laboratories has created significant regulatory difficulties and led to a great deal of low-level duplicative investment and construction, resulting in overcapacity and low or even harmful product quality, deepening the difficulty and depth of China's "three cuts, one reduction and one shore-up" supply-side structural reform and slowing the healthy development of the cell therapy industry.
As China's first local standard for cell preparation centers, the newly released "Code for the Construction and Management of Cell Preparation Centers" will lead and accelerate the entry of China's cell therapy industry into a more legalized, standardized and professionalized era, advance the standardization of cell preparation and related services, and raise the quality level of cell products.
The biotechnology industry is one of Shenzhen's key strategic emerging industries. As part of this, Shenzhen has actively developed the cell therapy innovation chain and industrial chain, with focused planning across research, production, quality inspection and clinical use, enabling cell therapy technology to make the "triple jump" in Shenzhen from scientific research to experimental development to widespread application. Inaugurated in September last year, the Shenzhen Comprehensive Cell Bank and Shenzhen (Beike) Regional Cell Preparation Center are key support and innovation platforms for Shenzhen's deployment of the personalized cell therapy "innovation chain + industrial chain". They are also the necessary infrastructure for delivering precision, individualized cell therapy, capable of providing regional medical institutions and research bodies in Shenzhen and across South China with services for the storage and preparation of research-grade and clinical-grade cells, as well as a standardized cell quality control system. Beike Biotech has now received government approval to build "Comprehensive Cell Banks" and "Regional Cell Preparation Centers" in Shenzhen, Nanchang, Guiyang, Yulin, Urumqi, Handan, Shijiazhuang, Qinhuangdao and other locations. Of these, the Comprehensive Cell Bank+Regional Preparation Centers in Shenzhen and Nanchang have been completed and put into operation.
