On 22 June, the Shenzhen Municipal Market Supervision Administration issued a notice that the "Code for the Construction and Management of Cell Preparation Centers" (No. SZDB/Z 188-2016) had been officially approved and released, and would come into force on 1 July 2016. The code is an important component of the Shenzhen standards system. It was 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.
The Shenzhen municipal government has long pursued innovation-driven, quality-led development. Building on its "Shenzhen Quality" strategy, it has been the first to put forward the development concept of "creating Shenzhen Standards to build new advantages for quality development", advancing toward the goal of realizing the "dream of a quality-driven nation". The release of this code is of great significance for the standardized construction and management of cell preparation centers, advancing the standardization of cell preparation and related services, raising the quality level of cell products and driving the sustainable, healthy development of the cell therapy industry.
In recent years, the absence of a standards system has become a bottleneck holding back the development of the 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, 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 seriously hampering the healthy development of the cell therapy industry.
In planning the development of the cell therapy innovation chain and industrial chain, Shenzhen brought together parties along the chain – covering research, production, quality inspection and clinical use – with different key capabilities, so that incubated cell therapy technology in Shenzhen could realize, in General Secretary Xi's words, the "triple jump from scientific research, to experimental development, to widespread application". Shenzhen was the first in the country to build the infrastructure for the development of the cell therapy technology industry – the Comprehensive Cell Bank + Regional Cell Preparation Center – separating cell preparation from clinical research applications. It was also the first to commission a leading enterprise, Beike Biotech, to develop and release China's first local standard for cell preparation centers, providing a useful reference for the formulation of national cell therapy industry standards. The implementation of this code will undoubtedly lead and accelerate the cell therapy industry's entry into a more legalized, standardized and professionalized phase.
As an industry leader, Beike Biotech was the first in Shenzhen to be approved to build a Regional Cell Preparation Center, and was entrusted with drafting this code. This is a strong endorsement of Beike Biotech's efforts in standardization in the cell therapy field by regulators and industry experts, and also marks another solid step forward in the development of the "national network of Comprehensive Cell Banks and Regional Cell Preparation Centers". Beike Biotech will continue to explore a virtuous development model of standardization, regulation and institutionalization for the cell therapy industry, working tirelessly to become a leading enterprise in the clinical translation of biotherapeutic technologies and to improve human health!
Annexes:
1. "Notice of the Shenzhen Municipal Market Supervision Administration on Releasing the Code for the Construction and Management of Cell Preparation Centers"
2. Code for the Construction and Management of Cell Preparation Centers
