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

Venor® Mycoplasma dPCR

Venor® Mycoplasma dPCR enables rapid and reliable detection of mycoplasma in cell cultures, biopharmaceutical products and ATMPs with digital PCR.
- EP 2.6.7 (12.2) and USP <77> compliant
- Highest sensitivity on market through detection of both RNA and DNA
- Compatible with QIAcuity® digital PCR system
- Fast results in < 3 h

A dedicated ddPCR™ version for use on QX200™ and QX600™ systems is coming soon.
Become a beta tester! Contact support@minerva-biolabs.com.

Cat. No.: 111-0001

€427.00
Tax excluded excl. Shipping costs
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Resources

Manual.pdf
Compliance Information.pdf
SDS.pdf
Data Sheet.pdf
Validation Report
Validation Report for Venor® Mycoplasma dPCR

Validation Reports can only be requested by email.

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Validation Guide
Venor® Mycoplasma dPCR Validation Guide for Venor® Mycoplasma dPCR

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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 dPCR is a digital 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 has specifically been developed for use with the QIAcuity® digital PCR system and 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.

Venor® Mycoplasma dPCR specifically detects mycoplasma 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 dPCR.

Specifications

Application Mycoplasma detection
Application areas
  • QC release of biopharmaceuticals and ATMPs
  • QC of cell cultures
Contents
  • Mycoplasma Mix
  • Positive Control
  • Internal Control
  • dPCR grade Water
Compliance EP 2.6.7, USP <77>, JP18 G3
Validation report available
Time-to-result < 3 h
PCR type Digital PCR with reverse transcription
Compatible devices QIAcuity® digital PCR device
Detection limit (LOD) ≤ 10 CFU/ml
< 100 GC/ml
Detection spectrum ≥ 130 mollicutes
Control system
  • Positive control
  • Internal control
Number of reactions
  • 111-0001: 24 reactions
  • 111-0002: 96 reactions
Price per reaction
  • 111-0001: €17.79
  • 111-0002: €16.16
Required equipment
and consumables
  • QIAcuity® digital PCR device
  • QIAcuity® Nanoplate 26k
  • QIAcuity® OneStep Advanced Probe Kit
  • 1.5 ml reaction tubes
  • PCR tubes
  • Centrifuge
  • Pipettes
  • Vortex mixer
  • Venor® Mycoplasma Extraction
Optional for product-specific validation and as EPC/EIC: 10CFU®/100CFU®/100GC® Mycoplasma Standards
(Please refer to the manual for complete list and recommendations)
Storage 2-8 °C; ≤ –18 °C after opening or 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:
Request free sample