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Venor® Bacteria qPCR
Venor® Bacteria qPCR enables rapid detection of bacterial contamination in cell cultures and ATMPs.
- Time-to-result: < 3 hours
- QC release testing of ATMPs and other short-shelf life products
- Detects 95 % of bacteria including VBNCs
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Product Description
Venor® Bacteria qPCR is a real-time PCR assay for rapid detection of bacterial contamination in cell cultures, cell culture-derived biologicals, and Advanced Therapy Medicinal Products (ATMPs). Unlike traditional culture-based sterility testing, the assay also detects slow growing and viable but non-culturable (VBNC) bacteria. By targeting the highly conserved 16S rRNA coding region in the bacterial genome, Venor® Bacteria qPCR provides highly sensitive and reliable results in under 3 hours.
Two workflows support different applications:
- Rapid screening in research & development
- QC release testing of cell-based products and ATMPs as a fast alternative to conventional sterility testing
Specifications
| Application | Bacteria detection |
|---|---|
| Application areas | QC release testing of ATMPs or screening in R&D |
| PCR type | Real-time PCR |
| Compliance | EP 5.1.6, EP 2.6.27 and USP <1223> |
| Time-to-result | < 3 hours |
| Sensitivity | LOD: 2.5 - 99 CFU/ml depending on species; including all bacteria species listed in EP 2.6.1 and 2.6.27 |
| Detection spectrum | 95 % of Gram-positive and Gram-negative bacteria |
| Control system | Internal Control DNA and Positive Control DNA included |
| Kit components |
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| Required equipment and consumables |
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| Number of reactions |
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| Price per reaction |
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| Storage | 2-8 °C; ≤ –18 °C after rehydration |
| Shipping | Ambient temperature |
| Shelf life (max.) | 18 months |
Regulatory Disclaimer
For research and industrial use only. Not for diagnostic or therapeutic use.
Minerva Biolabs offers a free sample of this product for testing:
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