On March 19, 2020, the Shenzhen Market Supervision Administration released the 2019 list of Shenzhen Standard Innovation Bases pursuant to the Implementation Plan of the Municipal Party Committee and Municipal Government on Carrying out the Quality Standard Enhancement Action to Promote High-Quality Development (2019-2022) (Shen Fa [2019] No. 11). Among the five enterprises selected, Beike Biotech, which has consistently driven standardization in the cellular biological products industry, was included. This is both an honor and a responsibility, and represents recognition by the regulators of Beike Biotech's continuous efforts to advance the standardization of the cell industry.


This is yet another distinction in the field of standardization, following Beike Biotech's recognition in 2019 as a "Shenzhen Demonstration Enterprise for Synchronized R&D and Standardization."

The Shenzhen Market Supervision Administration's selection of Shenzhen Standard Innovation Demonstration Bases is intended to implement the innovation-driven development strategy, refine the full-chain standardization service model, and accelerate the construction of a technical-standard innovation service system that meets the needs of scientific and technological innovation, industrial upgrading, and economic and social development, using the demonstration effect of leading enterprises to drive innovation-led development across Shenzhen's enterprises.

The cell industry directly concerns life and health, making standardization especially important. As a leader in this field, Beike Biotech started its corporate standardization journey early on. Drawing on AABB's management standards for cell therapy products, Beike has built a complete internal corporate standardization management system, integrating more than 500 documents across more than ten modules to coordinate operations and form a closed loop of cell quality management from donor to preparation to testing. At the same time, standardized management is introduced from the R&D stage to ensure the authenticity and credibility of research outcomes and to safeguard the efficient and orderly translation of R&D results into production.

While building internal corporate standardization, Beike Biotech has also continually advanced industry-wide standardization for the cell sector. Jointly drafted by the Shenzhen Market Supervision Administration together with the Shenzhen Development and Reform Commission, Shenzhen Beike Biotechnology Co., Ltd., and the Shenzhen Institute of Standards and Technology, the "Specification for the Construction and Management of Cell Preparation Centers" (No.: SZDB/Z 188-2016) was officially released in June 2016; the "Specification for the Construction and Management of Comprehensive Cell Banks" (No.: SZDB/Z 266-2017) was officially released in September 2017, providing valuable references for the formulation of industry standards in cell therapy in China.

Going forward, as a "Shenzhen Standard Innovation Demonstration Base," Beike Biotech will continue to fulfill its responsibilities, showcase standardization and innovation outcomes, drive more efficient corporate development, contribute its strengths to the development of group, industry, national and even international standards in the cell field, support the building of "Shenzhen Standards," and advance standardization work in cell therapy across the Greater Bay Area.

Beike Biotech standardization milestones


01 —— In 2016, Beike Biotech took the lead in drafting the Shenzhen local standard "SZDB/Z 188-2016 Specification for the Construction and Management of Cell Preparation Centers";
02 —— In 2016, Beike Biotech participated in formulating the "Self-Regulatory Specification for Quality Management of Stem Cell Preparation" and the "Self-Regulatory Specification for Quality Management of Immune Cell Preparation";
03 —— In 2017, Beike Biotech took the lead in drafting the Shenzhen local standard "SZDB/Z 266-2017 Specification for the Establishment and Management of Comprehensive Cell Banks";
04 —— In 2018, Beike Biotech participated in drafting the group standard "SZTT/SSCT 002-2018 Specification for Human Umbilical Cord-derived Mesenchymal Stem Cell Preparations for Clinical Research";
05 —— In 2018, Beike Biotech issued "Q/BKSW 001—2018 Umbilical Cord-derived Mesenchymal Stem Cells for Scientific Research";
06 —— In 2019, Beike Biotech was recognized by the Shenzhen Market Supervision Administration as a "Demonstration Enterprise for Synchronized R&D and Standardization."
07 —— In 2020, Beike Biotech was recognized by the Shenzhen Market Supervision Administration as a "2019 Shenzhen Standard Innovation Demonstration Base."
"Notice of the Shenzhen Market Supervision Administration on Releasing the 2019 Confirmed List of Demonstration Enterprises for Synchronized R&D and Standardization and Shenzhen Standard Innovation Demonstration Bases"
http://amr.sz.gov.cn/xxgk/qt/tzgg/202003/t20200319_19064470.htm

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