Standardized planning
Beike Biostandardization
Beike Biotechnology is the first enterprise in China to introduce the concept of quality management in the field of cell biomedicine, and carried out the ISO9001 quality management system certification for the first time in 2010, and completed the three-in-one certification of “quality, environment, occupational health and safety” in 2012. At the same time, Beike Biotech Jiangsu Branch is the first company in Chinese mainland to introduce and pass the “Association for the Advancement of Blood & Biological Therapy” (Association for the Advancement of Blood & Biotherapies, abbreviated as AABB, formerly the American Association of Blood Banks). In May 2017, the four autologous cell storage and application technology quality management systems of Beike Biotech Shenzhen Cell Bank (Shenzhen Comprehensive Cell Bank) (Shenzhen Comprehensive Cell Bank) passed the AABB certification at the same time, marking that Beike Biotech has established an integrated technical management model for cell preparation, storage and clinical transformation application services.
The development trajectory of Beike biological standardization construction
Beike certification milestones
From 2005 to 2013, the initial construction and growth of standardization 1
- ★ Establish enterprise technical standards and introduce international and domestic advanced standardized management standards
- — In 2010, Beike Biotech carried out the ISO9001 quality management system certification for the first time
- — In 2012, the integrated system of Beike Biotechnology completed the three-in-one certification of “quality, environment, occupational health and safety”.
- — In 2011, Beike Biotech Jiangsu Branch introduced the AABB certification system into Chinese mainland and passed its umbilical cord blood and umbilical cord mesenchymal stem cell certification.
From 2014 to 2017, the standardization system developed rapidly 2
- ★ Standardization research institutions are invited to guide
- — Establish an internal standardization team
- — Improve the enterprise standardization management system
- ★ AABB Cell Therapy Product System Certification
- — In 2016, the Shenzhen local standard “Code for the Construction and Management of Cell Preparation Center” (No. SZDB/Z 188-2016), which was jointly drafted by Beike Biotechnology and Shenzhen Institute of Standards and Technology, was officially released
- — In 2017, the Shenzhen local standard “Code for the Construction and Management of Comprehensive Cell Banks” (No. SZDB/Z 266-2017), jointly drafted by Beike Biotechnology and Shenzhen Institute of Standards and Technology, was officially released
- ★ Employed as the first batch of experts in Shenzhen Standard Library
2018-2019 New developments under the new Standardization Law 3
- ★ Standardization construction has been recognized
- — In 2019, Beike Biotech won the honor of “Standardization and Innovation Synchronous Demonstration Enterprise” in Shenzhen
- — In 2020, Beike Biotech won the title of “2019 Standardization Innovation Demonstration Base”.
- ★ Prepare for the establishment of associations in the industry
- — In 2019, in order to promote industry collaboration and standardization, the China Maternal and Child Health Association and the National and Local Joint Engineering Laboratory of Individualized Cell Therapy Technology jointly initiated the establishment of the “China Maternal and Child Health Association Maternal and Child Biosample and Bioinformatics Data Research and Application Branch”
Since 2020, the standardization system has been gradually improved 4
- ★ Participate in the construction of group standards
- — 2021, Beike Biosciences participated in the compilation of the group standard of the Chinese Association of Research Hospitals: General Requirements for Laboratory Human Stem Cell Detection (T/CRHA 003—2021)
- — In 2022, Beike Biotech participated in the compilation of the group standard of the China Pharmaceutical Biotechnology Association: Informed Consent Specification for Stem Cell Donors (T/CMBA019-2022)
- ★ Participate in the construction of national standards
- — In 2023, Beike Biotech participated in the formulation of the national standard: GB/T 42398-2023 “Technical Specification for Cell Culture Cleanroom Design” was officially released
- ★ Assist in the review of various standards in the industry
- ★ Conduct industry standardization research and make suggestions for the development of the industry
- ★ Dr. Hu Junyuan, Chairman of Beike Biotechnology, won the 9th “Shenzhen Quality Strong City Gold Medal”
Ongoing efforts
International and domestic dual authentication
AABB Accreditation
AABB certification means that the storage institution has met international standards in cell processing, storage and distribution, and the cells stored in this cell bank have obtained “international certification”
Three-standard integrated certification system
Third-party independent testing organization
Beike Biotech takes the initiative to introduce the cell storage platform of a third-party cell quality testing laboratory to issue a legally effective test report for each tested cell
Work together to build a standardized construction in the cell field
Lead/participate in the construction of standardization
Suggestions for industry standardization
Standardization cooperation
Authorities-in-charge: Quality Management Department, Quality Engineering Group
Ms. Lee
Head of Standardization
Mr. Yang
Head of Standardization