Contamination Control Compass
Edition #06/2026

 

Informative Articles
CFU or genome copies? Choosing the right reference material for PCR-based mycoplasma validation

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Photo: iStock.com | nicolas_

With the latest updates to EP 2.6.7 and USP <77>, genome copies are becoming increasingly important in PCR-based mycoplasma testing.

In our latest article, we explain the difference between CFU and genome copies, why this matters for NAT-based methods, and how suitable reference material can support method validation and routine testing.

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Product Highlights
Now available: Venor® Mycoplasma dPCR

Photo of Venor® Mycoplasma dPCR packaging in front of a QIAcuity dPCR cycler

Introducing Venor® Mycoplasma dPCR, our new digital PCR assay for rapid and reliable mycoplasma detection in cell cultures, biopharmaceuticals and ATMPs.


The assay detects both mycoplasma DNA and RNA using reverse transcription technology to provide exceptional analytical sensitivity. Validated according to the latest EP 2.6.7 (12.2) and USP <77> requirements, it is a strong choice for regulated mycoplasma testing in biopharma and ATMP environments.

Benefits at a glance:

  • Market-leading sensitivity through combined DNA/RNA detection

  • Time-to-result in less than 3 hours

  • EP 2.6.7 and USP <77> compliant

  • Compatible with 10CFU®, 100CFU® and 100GC® Mycoplasma Standards for product-specific validation and as EPC/EIC

  • Available for the QIAcuity® digital PCR System

  • A dedicated ddPCR™ version for use on QX200™ and QX600™ systems is coming soon. To be one of the first beta testers, contact us here.

Discover a new level of sensitivity
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QUICK TIP

Use aerosol-filter tips: Aerosol filter tips prevent contaminants from entering the pipettes and being transferred between samples. They therefore reduce the risk of cross-contamination and help ensure reliable results in PCR and mycoplasma tests.

 

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Your MB Team

 

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