Service Background

As an emerging treatment method, stem cell drugs are gradually becoming a hot topic in modern medical research. In order to ensure the safety and effectiveness of stem cell drugs, strict quality control projects and efficient testing capabilities are indispensable.

Stem cell drug quality control testing

1. Cell identification and purity testing
The service includes detailed phenotypic identification of stem cells to ensure that the purity and characteristics of the cells meet the treatment requirements. Through technologies such as flow cytometry and immunohistochemistry, cell surface markers can be accurately identified and quantified to ensure the consistency and reliability of the drug.

2. Sterility and microbial limit testing
The sterility testing technology and microbial limit testing methods are used to ensure that stem cell drugs are not contaminated by microorganisms during production, processing and storage. CTI Pharmaceutical Laboratory strictly follows international standard operating procedures to ensure the accuracy and repeatability of test results.

3. Endotoxin and inflammatory factor detection
The presence of endotoxin and inflammatory factors may affect the safety and efficacy of stem cell drugs. Provide efficient endotoxin detection services, as well as quantitative analysis of inflammatory factors, to ensure the safety of drugs and reduce patient risks.

4. Gene and protein expression analysis
Through high-throughput sequencing technology and proteomics analysis, the gene expression pattern and protein composition of stem cells can be evaluated to ensure the biological activity and therapeutic effect of drugs.

5. Cell function and stability assessment
The service also includes the evaluation of stem cell functions, including cell differentiation ability, proliferation potential and drug response. In addition, long-term stability testing can be provided to predict the shelf life and storage conditions of drugs.

Service Advantages

1. Advanced testing equipment: The laboratory is equipped with advanced equipment and instruments, including flow cytometers, cell culture incubators, PCR instruments, high-throughput sequencing platforms and protein analyzers.

2. Professional technical team: The professional team has rich experience and deep expertise, and can provide customized testing solutions to meet the needs of different customers.

Service process