Quality management, embedded from the start.
Beike reports completing its first ISO 9001 quality-management certification in 2010 and integrated certification covering quality, environment, and occupational health and safety in 2012. The company also reports AABB accreditation for specified activities at its Jiangsu and Shenzhen operations. Certification or accreditation applies only to the organisation, facility, activities and period stated in the relevant record; it is not approval of every service, product or clinical use.
Four phases of standardization construction.
- 2005–2013
Initial construction and growth
Established enterprise technical standards and adopted advanced international and domestic management standards. First ISO 9001 certification (2010) and three-in-one certification (2012). In 2011, the Jiangsu Branch introduced the AABB system to mainland China, passing certification for cord blood and umbilical-cord mesenchymal stem cells.
- 2014–2017
Rapid system development
Engaged standardization research institutions, built an internal standardization team and improved the management system. Company records describe AABB accreditation work for specified activities, publication of two Shenzhen local standards (SZDB/Z 188-2016 and SZDB/Z 266-2017), and appointment to the first batch of experts in the Shenzhen Standard Library.
- 2018–2019
New developments under the new Standardization Law
Recognised as a Shenzhen “Standardization and Innovation Synchronous Demonstration Enterprise” (2019) and a “Standardization Innovation Demonstration Base.” In 2019, co-initiated the China Maternal and Child Health Association's branch for maternal & child biosamples and bioinformatics.
- Since 2020
A maturing standardization system
Participated in group standards (T/CRHA 003-2021, T/CMBA019-2022) and the national standard GB/T 42398-2023 (cell-culture cleanroom design). Chairman Dr. Hu Junyuan won the 9th “Shenzhen Quality Strong City Gold Medal,” and Beike continues to advise on industry standards.
Benchmarking advanced standards and certification.
AABB accreditation
AABB accreditation concerns the activities and facilities within the published scope. It does not mean that stored cells or a future treatment are individually approved or certified.
Three-standard integrated system
Beike reported 14 consecutive years of integrated certification covering quality (ISO 9001), environment (ISO 14001) and occupational health and safety (ISO 45001) as of January 2024.
Third-party testing
Where a programme requires it, an independent laboratory may perform defined quality tests and issue a report for the tested sample or batch. The test scope and acceptance criteria remain programme-specific.
Standards Beike has led or co-authored.
| Standard | Type | Number | Status |
|---|---|---|---|
| Construction and management standards for cell preparation centers | Shenzhen local | SZDB/Z 188-2016 | Published |
| Setup and management practices for comprehensive cell banks | Shenzhen local | SZDB/Z 266-2017 | Published |
| Technology and management standards for the transport of live human samples | Shenzhen local | DB4403/T 120-2020 | Published |
| Transport technology and management specifications for human cell products | Shenzhen local | DB4403/T 121-2020 | Published |
| Construction and management standards for cell preparation centers | Hebei local | DB13/T 5162-2019 | Published |
| Construction and management standards for comprehensive cell banks | Hebei local | DB13/T 5163-2019 | Published |
| Specification for informed consent of stem-cell donors (China Pharmaceutical Biotechnology Association) | Group standard | T/CMBA019-2022 | Published |
| Specification of human UC-MSC preparations for clinical research (Shenzhen Cell Therapy Association) | Group standard | SZTT/SSCT 002-2018 | Published |
| General requirements for laboratory human stem-cell testing (China Association of Research Hospitals) | Group standard | T/CRHA 003-2021 | Published |
| Technical specifications for cell-culture cleanroom design | National standard | GB/T 42398-2023 | Published |
Selected research and publications.
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Stem cell industry development research report 2019
National and Local Joint Engineering Laboratory of Individualized Cell Therapy Technology · China (Shenzhen) Comprehensive Development Research Institute
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Translation of the Standards of Cell Therapy Services (9th Edition)
China Research Hospital, 2020, 7(5):35
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Comparative analysis of quality-control standards for umbilical-cord-blood hematopoietic stem cells in the United States
China Standardization, 2021(16):85-89
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Enlightenment of the standard-innovation-demonstration-base evaluation for improving group-standard quality
China Journal of Standardization, 2021
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Research progress in stem cell standardization
Chinese Journal of Biologicals, 2022, 35(9)
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The development of China's cell-therapy industry from a standardization perspective
China Standardization, 2023(7):53-60
Authorities in charge: Quality Management Department · Quality Engineering Group