The Standardized Cell Testing Laboratory (SCTL) at the Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, was established on December 12, 2019. Following a trial operation period, SCTL successfully obtained accreditation from the China National Accreditation Service for Conformity Assessment (CNAS) on July 21, 2021, receiving both the CNAS accreditation mark and certificate. This achievement signifies international recognition of SCTL's analytical and testing capabilities.
SCTL has established a laboratory quality management system in accordance with the international standard ISO/IEC 17025:2017 and CNAS-specific accreditation requirements. The laboratory provides scientific, accurate, impartial, and efficient standardized quality assessments for cells and biological products with various therapeutic potential, such as Mesenchymal Stem Cells (MSCs), immune cells, hematopoietic stem cells, and neural stem cells. Cell quality assessment encompasses cellular characterization, functional analysis, purity analysis, and safety evaluation. Currently, SCTL's testing capabilities include cell morphology, chromosomal karyotype, cell surface markers, cell viability, endogenous and exogenous pathogen detection (including HIV-1, HBV, HCV, CMV, and EBV), bacterial and fungal sterility, mycoplasma, bacterial endotoxin, and tumorigenicity testing.
Standardized quality assessment and testing of cell preparations are crucial for the development of cell therapy technology and represent a current bottleneck in cellular industry development. As a cell quality analysis and testing service platform addressing key gaps in the cellular industry, SCTL not only emphasizes the development of intermediate platforms for translating cell technology from "laboratory results" to "clinical tools" but also dedicates itself to researching evolving standardized cell evaluation systems. This provides solid support for cell translational research in China and crucial backing for product development and industrial advancement.
Laboratory Personnel Structure
The laboratory operates under a director-responsibility system, with Technical and Quality Managers reporting to the Laboratory Director. These managers oversee comprehensive laboratory management and experimental testing management, respectively. The staff includes one senior professional with high-level professional title and seven professionals with intermediate professional titles. All personnel hold Good Clinical Practice (GCP) training certificates from the National Drug Clinical Trial Quality Management Standards.
Laboratory Director
Professor Guangjin Pan, Laboratory Director, has over a decade of experience in stem cell research. His primary research focuses on the epigenetic regulation mechanisms of pluripotent stem cells (PSC) pluripotency maintenance and exit, mechanisms of early tri-lineage cell fate determination, and human functional cell differentiation. He has published 30 papers as corresponding or first author in journals including Nature Methods, Cell Stem Cell, and Nature Communication, with over 2,000 total citations. His achievements include five granted patents (including one PCT), Second Prize of the National Natural Science Award (ranked 2nd), First Prize of the Guangdong Province Science and Technology Award (ranked 1st), selection for CAS Talent Project, Outstanding Contributor to the 2017 CAS Outstanding Scientific Achievement Award Research Group, and appointment as Chief Scientist of the National Key R&D Program.
Laboratory Equipment
The laboratory is equipped with instruments and equipment valued at over 4 million RMB, with annual calibration performed by the Guangzhou Institute of Measurement and Testing Technology.
Testing Process Flow
Contact Information
Contact Person: Ms. Chen
Phone: 020-32015308
Email: chen_qianyu@gibh.ac.cn
Address: 190 Kaiyuan Avenue, Guangzhou Science Park, Luogang District, Guangzhou
Testing Services
