[Shenzhen Business News] (Reporter Wang Hairong) A new member has been added to the Shenzhen standard system. The “Cell Preparation Center Construction and Management Specifications” (No.: SZDB/Z 188-2016), organized by the Shenzhen Municipal Market Supervision and Administration Bureau in conjunction with the Shenzhen Municipal Development and Reform Commission, and jointly drafted by Shenzhen Beike Biotechnology Co., Ltd. and the Shenzhen Institute of Standards and Technology, was officially approved and released on Implemented at the beginning of July. The introduction of this specification will help the construction and management of standardized cell preparation centers and promote the sustainable and healthy development of my country’s cell therapy industry.
In recent years, Shenzhen has insisted on being innovation-driven and quality-led. Based on the “Shenzhen Quality” strategy, it has proposed the development idea of ”creating Shenzhen standards to build new advantages in quality development” and has promoted advantageous enterprises to formulate standards in their fields. The introduction of this specification is regarded as the latest measure for Shenzhen’s biological industry to achieve standards leadership.
When reporters interviewed Beike Biotech, one of the standard setters, yesterday, they learned that the lack of a standard system has become a bottleneck hindering the development of my country’s cell therapy industry. At the same time, the large number of cell preparation laboratories has brought great regulatory difficulties and resulted in a large number of low-level duplication of investment and construction, resulting in overcapacity and low-quality and even harmful products. This has aggravated the difficulty and depth of my country’s supply-side structural reform of “three cuts, one reduction and one supplement”, and has slowed down the healthy development of the cell therapy industry.
The “Cell Preparation Center Construction and Management Specifications” issued this time, as my country’s first local standard for cell preparation centers, will lead and accelerate the process of legalization, standardization and specialization of my country’s cell therapy industry, promote the standardization process of cell preparation and services, and improve the quality level of cell products.
The bio-industry is one of the strategic emerging industries that Shenzhen focuses on. In this process, Shenzhen actively develops the cell therapy innovation chain and industrial chain, and carries out key layouts in the research, production, quality inspection and clinical aspects of cell therapy, enabling incubated cell therapy technology to achieve a “triple jump” from scientific research, experimental development, promotion and application in Shenzhen. Last yearShenzhen Comprehensive Cell Bank and Shenzhen (Beike) Regional Cell Preparation Center, which were launched in September, are important supports and innovation carriers for the “innovation chain + industrial chain” of Shenzhen’s layout and development of personalized cell therapy. They are also the necessary infrastructure for the implementation of precise and personalized cell therapy. They can provide the preservation and preparation of research-grade and clinical-grade application cells as well as standardized cell quality control system services for regional medical institutions and scientific research institutions in Shenzhen and even South China. At present, Beike Biotech has received government approval to build “comprehensive cell banks” and “regional cell preparation centers” in Shenzhen, Nanchang, Guiyang, Yulin, Urumqi, Handan, Shijiazhuang, Qinhuangdao and other places. Among them, the comprehensive cell bank+ regional preparation centers in Shenzhen and Nanchang have been completed and put into operation.