The revised European Pharmacopoeia (EP) chapter 2.6.7 “Mycoplasmas”, which will come into force on 1 April 2026, establishes a modern framework for nucleic acid amplification techniques (NAT) in mycoplasma testing and supports the increasing use of PCR-based methods in biopharmaceutical and ATMP quality control. The updated chapter defines clear performance expectations, including a required limit of detection (LOD) of ≤10 CFU/ml or <100 genomic copies (GC)/ml.
Another important change is the requirement to run an “external positive control” (EPC) alongside test samples.This strengthens confidence in routine testing by confirming assay performance and supporting reliable interpretation of negative results.
As the revised EP 2.6.7 now clearly defines quality requirements for mycoplasma reference materials, Minerva Biolabs has introduced a new generation of mycoplasma standards manufactured in accordance with the updated EP requirements. These standards are available for 10 mollicutes species listed in the EP and can be used for method validation, LOD verification, and as EPCs:
- 100GC® Mycoplasma Standards - 100 genome copies per vial
- 10CFU® Mycoplasma Standards - 10 CFU per vial with defined GC:CFU ratios <10
- 100CFU® Mycoplasma Standards - 100 CFU per vial with defined GC:CFU ratios <10
In addition to reference materials, Minerva Biolabs offers a complete portfolio of reverse transcriptase PCR assays for mycoplasma detection, enabling laboratories to choose the optimal technology for their workflow:
- Venor® Mycoplasma qPCR – real-time PCR
- Venor® Mycoplasma dPCR – digital (droplet) PCR
- Venor® Mycoplasma gelPCR – conventional PCR
Together, these assays and standards provide an integrated solution for EP 2.6.7-compliant mycoplasma testing in cell culture, biopharmaceutical and ATMP release testing, helping manufacturers generate reliable results within the timeframes required for modern therapies.
Learn more about the EP 2.6.7 update and what will change for you
Key takeaways
- EP 2.6.7 introduces defined NAT sensitivity requirements (CFU or GC-based)
- An external positive control (EPC) is now required in routine testing
- Minerva Biolabs provides PCR solutions for real-time PCR, digital (droplet) PCR, and conventional PCR workflows
- New 10CFU®, 100CFU®, and 100GC® Mycoplasma Standards support method validation and EPC use
