Mycoplasma is widely distributed in nature, and it is easy to cause pollution in the process of cell culture. It is a necessary item in the quality control of biological products. The traditional culture method of mycoplasma takes a long time, which is difficult to meet the process monitoring requirements of raw materials and excipients, and brings challenges to the release and detection of cell therapy products. Foreign pharmacopoeia (USP,EP, and JP) have included Nucleic acid amplification techniques for detection of mycoplasma, which has not been formally included in domestic pharmacopoeia, but CDE documents support enterprises to develop new detection methods of mycoplasma. After verification, it is used for release detection.
The qPCR technology based on Taqman probe and matching mycoplasma DNA extraction kit can be used to complete the rapid detection of mycoplasma in 4 hours, with a sensitivity of 10CFU/mL. It is suitable for the detection of samples of different volumes, helping enterprises to detect raw materials, cell bank and stock solution, and reducing the risk of mycoplasma contamination.
| Product name | Item number | Specification |
| Mycoplasma DNA test kit | ||
| RocGene Mycoplasma DNA test kit | 102002009 | 50 Tests |
| RocGene Mycoplasma DNA Extraction Kit (Column Extraction) | 102004002 | 50 Tests |
| Quantitative PCR instrument | ||
| Archimed R4 time resolved quantitative PCR system | 161004 | 1 PC |
| Archimed R6 time resolved quantitative PCR system | 161006 | 1PC |
| Software and services | ||
| ArchiSign data audit trail software | 161002 | 1 Licence |
| 3Q Authentication service package | 161003 | 1 set |
