Contamination Control Compass
Edition #10/2025

 

Regulatory Update
The New European Pharmacopoeia Chapter 2.6.7 – A Milestone for Mycoplasma Testing

Calender with publication date of EP 12.2

The European Pharmacopoeia Commission has released the new version of chapter 2.6.7 (Edition 12.2), which will become effective in April 2026.


This update marks a major milestone in mycoplasma testing compliance, as PCR-based mycoplasma detection methods are now officially recognized as fully equivalent to traditional culture assays.

With a defined detection limit of 10 colony-forming units per ml (10 CFU/ml) or less than 100 genomic copies per ml (100 GC/ml), the new regulation sets a clear benchmark for nucleic acid amplification techniques (NAT) based mycoplasma testing and confirms the central role of molecular methods in future quality control and contamination detection.

 

Product Highlights
Be prepared for April 2026 with our new Venor® Mycoplasma qPCR

Package of new mycoplasma detection kit 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.

It is fully aligned with the new requirements and provides a ready-to-use solution for EP-regulated environments.

  • EP 2.6.7 (Edition 12.2), USP <63>, USP <77> Draft and JP 18 <G3> compliant

  • Highest sensitivity through detection of both RNA and DNA due to reverse transcriptase PCR

  • Detection limit (LOD): <100 GC/ml and ≤10 CFU/ml

  • Detection spectrum: >130 mollicutes

  • Compatible with all common qPCR cyclers

  • Positive and internal control included

  • Easy handling and clear result interpretation

  • Validation report available on request

It’s the ideal choice for GMP-regulated facilities and ATMP developers who require maximum reliability and compliance in every batch release.

If you work in research without regulatory obligations, nothing changes. Users of Venor®GeM OneStep, Venor®GeM Advance and Venor®GeM qOneStep are not affected by the new EP 2.6.7.

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Product Highlights
Complete your setup for EP 2.6.7 (12.2)

Package of new 100GC® Validation Standards

For PCR-based methods, a sensitivity limit of 100 GC/ml has been introduced alongside the existing 10 CFU/ml requirement, a PCR-appropriate unit that reflects what molecular laboratories have been using and expecting for years.

To ensure you’re fully prepared from the very beginning, we’re introducing the matching 100GC® Mycoplasma Standards, available for the following mycoplasma species:

  • A. laidlawii

  • M. fermentans

  • M. hyorhinis

  • M. orale

  • M. pneumoniae

  • M. arginini

  • M. salivarium

  • M. gallisepticum

  • M. synoviae

  • S. citri

All 100GC® Mycoplasma Standards provide non-infectious, quantitative reference materials designed to support matrix-specific validation.

  • Product-specific validation according to EP 2.6.7

  • External positive control

  • RNA-containing DNA standard with 100 GC/vial (lyophilized)

Together with the Venor® Mycoplasma qPCR kit, they form a complete, ready-to-use solution that meets the new EP 2.6.7 requirements and significantly simplifies your validation process.

For reference and comparability, 10 CFU/ml standards remain available and can continue to be used for validations alongside the new 100 GC/ml.

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Need guidance for the next step?

Whether you’re preparing for the EP 2.6.7 transition or selecting the right mycoplasma standards for your validation – we’re here to help.

Contact our expert team for personal support and make sure your mycoplasma testing is ready for April 2026.

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Warm regards,

Your MB Team

 

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