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 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. Beike Biotechnology also successfully completed on-site evaluation for AABB (American Association of Blood Bank) accreditation in September 2011.
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.
- Laboratory standards for clinical-grade adult stem cell processing
- Safety and quality control system for clinical-grade adult stem cells
- Research and management system for clinical-grade adult stem cells
- 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:
- FDA-CBER*, OCTGT**, CDRH***
- Good Tissue Practices (GTPs)
- Good Manufacturing Practices (GMPs)
- Good Clinical Practices (GCPs)
- Institutional Review Board, Biosafety Committee
- Foundation for cellular Therapy (FACT)
- American Association of Blood Banks (AABB)
- American Association of Tissue Banking (AATB)
- United States Pharmacopeia (USP)
- College of American Pathologists (CAP)
- Clinical Laboratory Improvement Amendments (CLIA)
*The Center for Biologics Evaluation and Research, **Office of Cellular, Tissue and Gene Therapies, ***Center for Devices and Radiological Health.