Service Background

Mycoplasma is a type of cell wall-less microorganism that can cause contamination in cell culture and affect the quality and safety of biological products. In order to meet the quality requirements of cells used in biological product production and clinical treatment, CTI Pharma drug testing services can provide professional mycoplasma testing services to ensure the high quality standards of cell matrices and final products.

Mycoplasma Testing

Service items
1. Culture method testing
1) According to the requirements of ChP General Chapter 3301，mycoplasma liquid culture medium and semi-fluid culture medium are used for culture method detection.
2) Through constant temperature culture at 36℃±1℃, observe the color change of the growth medium and the growth of mycoplasma to determine the presence of mycoplasma.

2. Indicator cell culture method (DNA staining method)
1) Indicator cell culture is performed using uncontaminated Vero cells or other cells approved by the national drug inspection agency.
2) Through staining with specific fluorescent dyes, the mycoplasma DNA staining on the cell surface is observed using a fluorescent microscope to provide intuitive test results.

Applicable products
1. Master cell bank and working cell bank: ensure that the cell bank used for the production of biological products is free of mycoplasma contamination.
2. Virus seed batch and control cells: ensure the purity of cells in vaccine production and cell therapy.
3. Cells for clinical treatment: provide safe and non-contaminated cells for clinical treatment.

Target customers

This product serves many industries and fields. The following are representative customer targets:
1. Biotechnology companies;
2. Biopharmaceutical companies;
3. Cell banks and biological resource centers, etc.

Our advantages

1. Professional technical team: The team has deep professional knowledge and rich practical experience, and can accurately perform mycoplasma testing.
2. Strict quality control: Follow the provisions of ChP General Chapter 3301, implement strict quality control processes, and ensure the authority of the test results.
3. Comprehensive testing services: Provide comprehensive mycoplasma testing services from culture method to DNA staining method to meet the needs of different customers.
4. Customized services: expedited testing services, special sample processing and detailed interpretation of test reports.

Service process