On June 22, the Shenzhen Municipal Administration for Market Regulation issued a notice that the “Cell Preparation Center Construction and Management Specifications” (No.: SZDB/Z 188-2016) was officially approved and released and will be officially implemented on July 1, 2016. This specification is one of the important components of the Shenzhen standard system. It was jointly drafted by the Shenzhen Municipal Administration for Market Regulation, the Shenzhen Municipal Development and Reform Commission, Shenzhen Beike Biotechnology Co., Ltd. and the Shenzhen Institute of Standards and Technology.
Shenzhen Municipal Government has always adhered to the innovation-driven and quality-led strategy. On the basis of the “Shenzhen Quality” strategy, it took the lead in proposing the development idea of ”creating Shenzhen standards to build new advantages in quality development” and moving towards the goal of realizing the “dream of a strong country with quality”. The promulgation of this specification is of great significance for the construction and management of standardized cell preparation centers, promoting the standardization process of cell preparation and services, improving the quality level of cell products, and promoting the sustainable and healthy development of the cell therapy industry.
In recent years, the lack of a standard system has become a bottleneck in the development of the cell therapy industry. At the same time, the large number of cell preparation laboratories has brought great regulatory difficulties, and has resulted in a large number of low-level duplication of investment and construction, overcapacity and low-quality and even harmful products. It has aggravated the difficulty and depth of my country’s supply-side structural reform of “three cuts, one reduction and one supplement”, and has seriously affected the healthy development of the cell therapy industry.
Shenzhen has laid out the development of cell therapy innovation chain and industrial chain, and organized all parties with different key capabilities in the industrial chain covering research, production, quality inspection and clinical practice to incubate cell therapy technology in Shenzhen to achieve what General Secretary Xi said is the “‘triple jump’ from scientific research, experimental development, promotion and application.” Shenzhen is not only the first in the country to build the infrastructure for the development of the cell therapy technology industry – a comprehensive cell bank + regional cell preparation center, which separates cell preparation and clinical research applications; it is also the first in the country to entrust the leading company Beike Biotech to formulate and issue local standards for my country’s first cell preparation center, which provides useful reference for the formulation of standards for my country’s cell therapy industry. The implementation of this specification will surely lead and accelerate the process of legalization, standardization and professionalization of the cell therapy industry.
Beike Biotechnology, as a leading enterprise in the industry, was the first to obtain approval for the construction of a regional cell preparation center in Shenzhen and took on the drafting work of this specification. This is a high recognition of Beike Biotechnology’s standardization construction in the field of cell therapy by the competent authorities and industry experts. It also marks another solid step in the construction of the “Comprehensive Cell Bank and Regional Cell Preparation Center National Network”. Beike Biotech will continue to explore the healthy development model of standardization, standardization and institutionalization of the cell therapy industry, and make unremitting efforts to become a leading company in promoting the clinical transformation of biotherapy technology and improve human health!
Attachment:
1, “Notice of the Shenzhen Municipal Administration for Market Regulation on the Release of Construction and Management Specifications for Cell Preparation Centers”
2, Cell preparation center construction and management specifications