Beike Standards and Certifications

The highest international certifications for stem cell processing facilities and methods

Accreditations

Beike's Accreditation and Standards

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. 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
  • Laboratory standards for clinical-grade adult stem cell processing
  • 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:

*The Center for Biologics Evaluation and Research, **Office of Cellular, Tissue and Gene Therapies, ***Center for Devices and Radiological Health.

American Association of Blood Banks (AABB)

 

Foundation of Accreditation for Cellular Therapy

 

 

United States Pharmacopeia Convention (USP)

 

Center for Devices and Radiological Health (CDRH)

 

The Center for Biologics Evaluation and Research

 

AABB-certification-Beike-Shenzhen
Clinical Laboratory Improvement Amendments (CLIA)
American Association of Blood Banks (AABB)
Center for Devices and Radiological Health (CDRH)
United States Pharmacopeia Convention (USP)
The Center for Biologics Evaluation and Research

Pin It on Pinterest

Share This