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 Earliest 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


Environmental Management System Certificate
Quality Management System Certificate
Occupational Health and Safety Management System Certificate
Beike Biotechnology Testing center passed external quality assessment(EQA)for annual national accounting testing (virology) in 2015
Beike Biotechnology Testing center passed external quality assessment(EQA)for annual national accounting testing (virology) in 2015
External quality assessment(EQA)for annual national infectious diseases serological markers series C in 2015
Beike Biotechnology Testing center passed external quality assessment(EQA)for annual national infectious diseases serological markers series C in 2015.
Beike Biotechnology Testing center passed external quality assessment(EQA)for annual national blood type chamber in 2015.
Beike Biotechnology Testing center passed external quality assessment(EQA)for annual national blood type chamber in 2015.
Shenzhen Beike Biotechnology Testing center passed external quality assessment(EQA)for whole blood cell count in 2015.
Shenzhen Beike Biotechnology Testing center passed external quality assessment(EQA)for whole blood cell count in 2015.
Shenzhen Beike Biotechnology Testing center passed external quality assessment(EQA)for national infectious disease serological markers series A in 2015.
Shenzhen Beike Biotechnology Testing center passed external quality assessment(EQA)for national infectious disease serological markers series A in 2015.