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Venor® Mycoplasma qPCR
Venor® Mycoplasma qPCR offers a validated, real-time PCR-based solution for the rapid and reliable detection of mycoplasma in cell cultures, biopharmaceutical products and ATMPs.
- EP 2.6.7 (12.2) compliant
- Fast results in ≤ 3 h with minimal hands-on time ≤ 30 min
- Easy handling and clear result interpretation
- Highest sensitivity through detection of both RNA and DNA
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Product Description
Mycoplasmas are among the most significant contamination risks in cell culture and biopharmaceutical manufacturing (e.g., ATMPs). EP 2.6.7 requires a validated testing method for the release of such products.
The Venor® Mycoplasma qPCR Kit is specifically designed for use in QC and GMP laboratories. Compared to classical culture methods, it reduces detection time from several weeks to ≤ 3 hours and enables reliable release testing of biopharmaceuticals and ATMPs. The PCR-based method offers the advantage of detecting both culturable and non-culturable mycoplasmas, making it superior to traditional culture tests.
Detection is based on amplification of a highly conserved 16S rRNA coding region in the mycoplasma genome, enabling reliable identification of all mycoplasma, acholeplasma, and spiroplasma species listed in EP 2.6.7, as well as over 130 additional mollicutes. By combining reverse transcriptase and DNA polymerase, both RNA (as cDNA) and DNA are amplified, significantly increasing sensitivity. The assay has been validated according to current regulatory requirements EP 2.6.7 (Edition 12.2) and in compliance with ICH Q2(R2), meeting criteria for specificity, robustness, and sensitivity with detection limits of ≤ 10 CFU/ml and < 100 GC/ml. Positive control as well as internal and process controls further ensure the reliability of results and provide maximum security in routine testing.
The external positive control with defined concentration, as required by the new EP 2.6.7, can be obtained directly from us. Our 100GC® Mycoplasma Standards serve both as reference material for validation and as an external positive control in routine testing.
Specifications
| Application | Mycoplasma detection |
|---|---|
| Application areas |
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| Contents |
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| Compliance | EP 2.6.7 |
| Validation report | available |
| PCR type | RT-qPCR |
| Compatible devices | qPCR cyclers |
| Detection limit (LOD) | ≤ 10 CFU/ml < 100 GC/ml |
| Detection spectrum | ≥ 130 mollicutes |
| Control system |
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| Number of reactions |
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| Price per reaction |
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| Required equipment and consumables |
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| Storage | 2-8 °C; ≤ –18 °C after opening or rehydration |
| Shipping | Ambient temperature |
| Shelf life (max.) | 18 months |
Regulatory Disclaimer
For use in quality control/manufacturing process only.
Minerva Biolabs offers a free sample of this product for testing:
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