On Jun 22nd, Market Supervision Administration of Shenzhen Municipality had official approval of publication of ‘Specifications for Establishment and Management of Cellular Therapy Product Manufacturing Facility (SZDB/Z 188-2016)’ and formal implementation will be on July 1st, 2016. The specification is an important part of the standard system in Shenzhen, which is jointly drafted by Market Supervision Administration of Shenzhen Municipality, Development and Reformation of Shenzhen Municipality, Shenzhen Beike Biotechnology Co. Ltd. and Shenzhen Institute of Standards and Technology.
Shenzhen government insists on innovation driven and quality leading. This specification has important significance of promoting the sustainable and healthy development of cell therapy industry. It will standardize the construction and management of the cell preparation center to promote the standardization process of cell preparation and service in order to improve the quality level of cell products.
In recent years, the lack of standard system has become the bottleneck of the development of cell therapy industry. Meanwhile, a large number of cell preparation laboratories bring greater regulatory difficulties and resulted in a large number of low-level redundant investments in construction, excess capacity and low or even harmful product quality. The lack of standard system has seriously affected the healthy development of the cell therapy industry.
Shenzhen develops innovation chain and industry chain of cell therapy by organizing different parties to cover research, production, quality inspection and clinical industry chain. Shenzhen is the first one of the nation to build up the infrastructures for cell therapy technology industry development including cell bank and regional cell preparation center. Shenzhen separates cell preparation and application of clinical research. Moreover, Shenzhen is the first one to authorize the industry leading enterprise Beike Biotechnology to draft and publish the local specifications of cell preparation center in the country.
Beike Biotechnology, as the industry leading enterprises, got the approval in the construction of the regional cell preparation center. Beike took part in drafting the standards. The management department and industry experts have highly recognized standards of Beike in the field of cell therapy. Beike Biotechnology will continue to explore the standardization of cell therapy industry to promote the transformation to become a clinical biological treatment technology leader to improve human health with unremitting efforts!