On 20 February 2019, Shenzhen Municipal Administration for Market Regulation issued document Shenzhen Market Regulation [2019] No. 41, in which Shenzhen Beike Biotechnology Co., Ltd. (Beike Biotech) was awarded the title of "Demonstration Enterprise for Synchronized R&D and Standardization".
This honour reflects municipal authorities' recognition of Beike Biotech's work in R&D and standardization and marks another milestone for the company — as a leading enterprise in the cell technology industry — in advancing standardization for the sector.
The "Demonstration Enterprise for Synchronized R&D and Standardization" assessment has been conducted for two consecutive years since 2017. Established under the municipal government's "Implementation Plan for Building Shenzhen as an International Standards Innovative City" and the standard "Evaluation Guidelines for Demonstration Enterprises with Synchronized R&D and Standardization", it is an important component of building "Shenzhen Quality" and "Shenzhen Standard". Its purpose is to evaluate the effectiveness of enterprises in advancing R&D and standardization in parallel, to cultivate and recognize a group of demonstration enterprises with synchronized R&D and standardization, and to harness the leading and demonstrative effect of benchmark enterprises.
Cell preparation is a complex, advanced technology, and standardization in this area is relatively underdeveloped. As a pioneer in this field, Beike Biotech has consistently committed itself to industry standardization:
In 2011, Beike Biotech overcame numerous obstacles to become the first in China to obtain international AABB accreditation;
In 2016, Beike Biotech took the lead in drafting the Shenzhen local standards "Construction and Management Specifications for Cell Preparation Centers" and "Specifications for the Establishment and Management of Comprehensive Cell Banks";
In 2016, Beike Biotech participated in formulating the "Self-Regulatory Standard on Quality Management for the Preparation of Stem Cell Products" and the "Self-Regulatory Standard on Quality Management for the Preparation of Immune Cell Products";
In 2018, Beike Biotech became the first to apply for the professional title of "Cell Preparation Engineer" with the Human Resources and Social Security Bureau;
In 2018, Beike Biotech became the first in the field to introduce third-party quality testing.
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Beike Biotech is one of the earliest National High-Tech Enterprises in China specializing in the clinical translation and technical services of biotherapy technologies in strategic emerging industries. The company places great emphasis on R&D and standardization management, advancing and safeguarding the synchronized development of technical R&D, standards innovation, and industrialization through its organizational structure, budgets, and management systems.
Following self-evaluation, application, defence, expert review, and public notice, Beike Biotech successfully obtained the title of "Demonstration Enterprise for Synchronized R&D and Standardization", a recognition by the municipal government and society of the company's standardization and R&D work.
As a pioneer in this field, Beike Biotech will continue to increase its investment in R&D and standardization, drive more efficient enterprise development, deliver better services to users, and contribute further to national and industry standardization efforts.
