In accordance with the 2025 edition of the Chinese Pharmacopoeia, Part III, General Chapter 3301, Mycoplasma Examination Method, USP<77> Mycoplasma Nucleic Acid Amplification Tests, and EP2.6.7 Mycoplasmas, HyQure Biotech provides rapid mycoplasma testing services with same-day or next-day results. This method serves as an alternative or supplement to the culture method and the indicator cell culture method (DNA staining method), suitable for product release and in-process control.
For mycoplasma testing of master cell banks, working cell banks, virus seed lots, control cells, and cells used for clinical therapeutic purposes, both the culture method and the indicator cell culture method (DNA staining method) should be performed concurrently. For viral harvest fluids and bulks of viral vaccines, the culture method is used for mycoplasma testing. Where necessary, the indicator cell culture method may also be used to screen the culture medium. Other methods approved by the National Drug Control Authority may also be used.
When the limit of detection (LOD) of the mycoplasma testing method (qPCR method) reaches 10 CFU/mL, it may serve as an alternative to the culture method. When the LOD reaches 100 CFU/mL, it may serve as an alternative to the indicator cell culture method (DNA staining method). HyQure Biotech's mycoplasma testing (qPCR method) has been fully validated, and the LOD can reach 10 CFU/mL.
HyQure Biotech Provides the following rapid mycoplasma testing services
|
Service |
Method |
Purpose |
| Rapid Mycoplasma Testing of Test Sample |
Mycoplasma testing (qPCR method) |
To detect whether the test sample is contaminated with mycoplasma. |
| Alternative method validation for mycoplasma |
Mycoplasma testing of test sample |
To confirm that the test sample itself is free from mycoplasma contamination. |
|
Method validation of mycoplasma qPCR method |
To confirm that the kit performance meets experimental requirements and that the test sample does not interfere with mycoplasma testing. | |
|
Pharmacopoeial method suitability test |
To confirm that the test sample does not interfere with mycoplasma detection when performing the pharmacopoeial method under this protocol. | |
| Comparative validation |
To demonstrate that the sensitivity of the Mycoplasma testing (qPCR method) is not lower than that of the pharmacopoeial method. |