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Venor® Mycoplasma qPCR (Illustration similar or symbolic)
Illustration similar or symbolic

Venor® Mycoplasma qPCR

Venor® Mycoplasma qPCR enables rapid and reliable detection of mycoplasma contamination in cell cultures, biopharmaceuticals and ATMPs with real-time PCR.
- Compliant with EP 2.6.7 (12.2), USP <77> and JP18 G3
- Highest sensitivity on market through detection of both RNA and DNA
- Fast results in < 3h

Cat. No.: 111-9025

€799.00
Tax excluded excl. Shipping costs
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Resources

Manual.pdf
Compliance Information.pdf
SDS.pdf
Flyer.pdf
Data Sheet.pdf
Short instructions.pdf
Validation Report
Validation Report for Venor® Mycoplasma qPCR

Validation Reports can only be requested by email.

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Validation Guide
Venor® Mycoplasma qPCR Validation Guide for Venor® Mycoplasma qPCR

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Product Description

Mycoplasma contamination is a critical risk in cell culture, biopharmaceutical manufacturing, and advanced therapy medicinal products (ATMPs). For product release, EP 2.6.7 and USP <77> require a validated mycoplasma detection method.

Venor® Mycoplasma qPCR is a real-time PCR assay for the rapid, sensitive, and reliable detection of mycoplasma contamination in cell cultures, cell culture-derived biologicals, and Advanced Therapy Medicinal Products (ATMPs).

The assay is validated according to EP 2.6.7 (12.2), USP <77>, 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.

Mycoplasmas are specifically detected by amplifying the highly conserved 16S rRNA coding region of the mycoplasma genome. This enables broad and reliable detection of Mollicutes, including the species listed in the EP and USP. An integrated reverse transcription step allows the assay to detect both mycoplasma DNA and RNA, significantly increasing analytical sensitivity and supporting the detection of low-level contamination.

The kit includes a positive control and an internal control. The external positive control (EPC) / extraction inhibition control (EIC) is not included in the kit. For this purpose, we recommend using 100GC®, 10CFU®, or 100CFU® Mycoplasma Standards.

For product-specific validation (“test for inhibitory substances” or “method suitability test”), we recommend using 100GC® or 10CFU® Mycoplasma Standards.

The kit is provided with comprehensive manufacturer validation data. For sample preparation, we recommend Venor® Mycoplasma Extraction, as it has been validated in combination with Venor® Mycoplasma qPCR.

Specifications

Application Mycoplasma detection
Application areas
  • QC release of biopharmaceuticals and ATMPs
  • QC of cell cultures
Contents
  • Mycoplasma Mix (lyophilized)
  • Positive Control (lyophilized)
  • Internal Control (lyophilized)
  • PCR grade Water
Compliance EP 2.6.7, USP <77>, JP18 G3
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
  • Positive control
  • Internal control
Number of reactions
  • 111-9025: 25 reactions
  • 111-9100: 100 reactions
Price per reaction
  • 111-9025: €31.96
  • 111-9100: €28.90
Required equipment
and consumables
  • qPCR cycler (FAM™ and HEX™ alternatively VIC™ or JOE™)
  • PCR tubes
  • centrifuge for 1.5 ml PCR tubes
  • pipettes
  • Venor® Mycoplasma Extraction
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:
Request free sample

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