Jiachang Biological - biotechnology services and research and development as one of the high-tech enterprises
High qualityefficienttransparent
High quality, efficient and transparent
Home>Testing and Inspection Technology Platform>Testing and Inspection Technology Platform>Quality Testing Services for Cell Therapy Products
The production of stem cells and other types of cell therapy products involves in vitro cell culture. However, in vitro culture inevitably leads to changes in biological properties, biosafety concerns, exogenous contamination, and cross-contamination, all of which can significantly impact the progress and success of a product from early research to manufacturing. The diversity and complexity of stem cell products pose major challenges for quality control.
The comprehensive quality requirements for stem cells can be categorized into four main areas: basic biological properties, microbiological safety, biological safety, and biological efficacy. Canvest Bio is committed to working closely with you to develop a tailored stem cell quality control strategy that meets your specific needs.
Basic Biological Properties
Cell Identification:
Chromosomal Karyotype Analysis
Isoenzyme Testing
Short Tandem Repeat (STR) Analysis
Cell Activity Identification:
Cell Counting and Viability Testing
Cell Growth Curve Analysis
Cell Cycle Analysis (PI Staining Method)
Microbiological Safety Evaluation
In terms of microbiological safety, all therapeutic cell products, including various types of stem cells, must meet the microbiological safety standards for the cell substrates used in production. Relevant cells need to be tested for sterility, mycoplasma, mycobacteria, endogenous and exogenous specific or non-specific viruses, and endotoxins or microbial metabolites. Additionally, during the processes of stem cell collection, expansion, culture, passage, and cryopreservation, potential animal-derived microbial contamination in the materials used should be tested.
Canvest Bio provides the corresponding testing services, including links (for cell line testing and raw material testing.)）
Biosafety Evaluation
The biosafety of stem cells is primarily determined by their cellular biological characteristics, cell source, preparation process, and other related risk factors. Various risk factors can lead to abnormal immune responses, tumorigenicity and/or tumor-promoting effects in cell products. Currently, the biosafety evaluation of stem cells focuses mainly on immunological responses and tumorigenicity.
Tumorigenicity Testing
Telomerase Activity Assay
Immunological Response Testing
Lymphocyte Proliferation Inhibition Assay
Specific Lymphocyte Subpopulation Detection (Th1, Th17, Treg)
Lymphocyte Secretion of TNF-α Inhibition Assay
Biological Efficacy Testing
Canvest Bio offers corresponding testing services for the biological efficacy of Mesenchymal Stem Cells (MSCs).
Biological Efficacy Evaluation
Osteoblast Differentiation Assay
Chondrocyte Differentiation Assay
Adipocyte Differentiation Assay
Canvest Bio continuously explores the field of biological product quality control to provide reliable testing services, with new services under ongoing development.
