Full oversight, end to end
Beike maintains full oversight of cell manufacturing, from the testing of blood products, to cell processing at our laboratories, to delivery of the cells for clinical use. The highest quality control procedures are followed at each of Beike’s laboratories for both research and cell processing.
Quality
Quality is a top priority at Beike Biotechnology.
Beike has an extensive ‘start-to-finish’ quality control protocol in place that starts from the selection of stem cell donors all the way to the delivery of stem cells to the treatment centers.
Strict Quality Control Systems
Beike Biotechnology has established more than 20 adult stem cell processing laboratories, in accordance with GMP standards, and has been awarded ISO9001 and ISO17025 certificates. Jiangsu Beike’s inspection center was accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in 2011, and it is the first adult stem cell processing laboratory accredited by CNAS.
GMP Standard Laboratory
Beike Biotechnology has more than 20 GMP standard laboratories across the country with class-100 clean rooms outfitted with hi-tech equipment, including BD high-speed sorting flow cytometry (8 colors), Olympus fluorescence microscopes, Chart MVE gas storage systems, ABI fluorescence quantitative PCR devices, and automated stem cell separation and storage systems.
China’s First and Most Integrated Stem Cell Quality Control System
Beike Biotechnology adheres to a strict biological quality management system and established the earliest and most complete quality standard system for adult stem cells.
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Laboratory standards for clinical-grade adult stem cell processing
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Safety and quality control system for clinical-grade adult stem cells
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Research and management system for clinical-grade adult stem cells
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Disease-specific translation protocols for clinical-grade adult stem cells
The Construction of Beike Biotechnology quality management system is based on the following regulations and standards for cell therapy products:
Good Tissue Practices (GTPs)
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Good Manufacturing Practices (GMPs)
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Good Clinical Practices (GCPs)
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Institutional Review Board, Biosafety Committee
**The Center for Biologics Evaluation and Research, **Office of Cellular, Tissue and Gene Therapies, **Center for Devices and Radiological Health.
Logo The American Association of Tissue Banks (AATB)
United States Pharmacopeia Convention (USP)
Center for Devices and Radiological Health (CDRH)
The Center for Biologics Evaluation and Research
Cap College of American Pathologist
How Every Batch of Cells Is Controlled
Every batch is tracked from donation to injection.
- Donor screening: Donating mothers are screened for infectious disease, including HIV, hepatitis B, hepatitis C and syphilis, alongside a family medical history. Beike follows the People’s Republic of China’s regulations on blood donation, and no fewer than five rounds of pathogen testing are carried out by nationally qualified third parties. Details are on the cell processing page.
- Cold chain: Cells travel in temperature-controlled containers with real-time logging, and each shipment carries a full transport record.
- Quality control: Each batch passes up to 910 individual checkpoints covering cell characteristics, purity, safety, effectiveness and stability. It is tested twice before release, once internally and once by an independent third-party laboratory. Cells that fail are not released for clinical use.
- Traceability: Every cell product label carries a unique traceability code. You or your doctor can enter it into Beike’s online verification system before a dose is given and see the production facility, batch information, quality testing report and release status. How the traceability system works.
Where Treatment Happens, and Under Which Regulations
Treatment is delivered at affiliated hospitals in Bangkok, Thailand and in Dongguan, China, near Beike’s headquarters in Shenzhen. More about the two locations is on the treatment location page.
Patients and families often ask about approval in the United States. Our stem cell treatments are not approved by the US Food and Drug Administration, and they are not offered in the United States. They are delivered in Thailand and China, under those countries’ regulations for cell therapy.
The laboratories that prepare the cells are accredited as follows:
- Jiangsu Beike’s inspection centre was accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in 2011, the first adult stem cell processing laboratory to be accredited by CNAS.
- The laboratories operate to GMP standards and hold ISO 9001 and ISO 17025 certification. The Shenzhen cell bank is built to GMP and AABB standards and stores cells below -150 °C in vapour-phase liquid nitrogen.
- Beike’s quality management system is built on the published standards listed above (FDA CBER, OCTGT and CDRH, Good Tissue, Manufacturing and Clinical Practices, FACT, AATB, USP, CAP and CLIA). Following those standards does not mean the treatment has FDA approval.
The certificates are reproduced below.
