Redeveloped Mycoplasma Standards Designed for Ph. Eur. 2.6.7 and USP <77>
Sep 10, 2026 | Informative Articles
Pharmacopoeia-aligned reference standards and a complete PCR workflow for reliable mycoplasma testing in under four hours
The revised European Pharmacopoeia chapter 2.6.7, official since 1 April 2026, and the United States Pharmacopeia chapter <77>, official since 1 October 2026, establish updated requirements for nucleic acid amplification technique (NAT)-based mycoplasma testing. Alongside a sensitivity of ≤10 CFU/ml, genome copies are now recognized for molecular methods, with a required sensitivity of <100 GC/ml. The requirements for reference materials have also become more clearly defined, including a GC:CFU ratio of <10.
Reliable and well-characterized reference materials are a key prerequisite for robust mycoplasma method validation. Since CFU and GC reflect different biological properties, accurate characterization in both units and a low, defined GC:CFU ratio are essential for meaningful comparability between culture-based and molecular methods.
To address these requirements, Minerva Biolabs has redeveloped its 10CFU®, 100CFU®, and 100GC® Mycoplasma Standards using state-of-the-art production and characterization technologies.
A key advancement is the use of validated digital PCR (dPCR) for absolute genome copy quantification. Combined with additional quality controls to verify dilution linearity, this enables highly precise calibration of the standards and improved alignment between culture-based CFU values and NAT-based genome copy results.
Key benefits at a glance:
- Ready-to-use target levels of ≤10 CFU or <100 GC
- Highly precise quantification using digital PCR
- High batch-to-batch consistency
- GC:CFU ratio <10 for CFU-based standards, with the exact value provided in the CoA
- Suitable for LOD verification, product-specific validation, and use as external positive or extraction inhibition controls
- Lyophilized format enabling transport at ambient temperature and storage at 2–8 °C
Not sure which standard to use?
Find out whether 10CFU®, 100GC® or 100CFU® is the right choice for your application.
From validation standard to result – one complete workflow
Combined with Venor® Mycoplasma Extraction and the Venor® Mycoplasma qPCR or dPCR assays , the standards are part of an integrated workflow for regulatory mycoplasma testing.
For maximum sensitivity, the Venor® Mycoplasma qPCR and dPCR assays include reverse transcription, enabling detection of both mycoplasma RNA and DNA. This allows the assays to achieve the pharmacopoeial target sensitivity of ≤10 CFU/ml or <100 GC/ml directly, without centrifugation-based pre-concentration.
One workflow. One validated system. Several benefits:
- Suitable for high cellular backgrounds of up to 1 x 107 cells/ml
- Only 250 µl sample input required – ideal for ATMP samples
- No pre-concentration required
- Highest sensitivity through reverse transcription
- Time-to-result: 4 hours
The result is a complete solution covering sample preparation, method validation, controls, and mycoplasma PCR detection.
