Important Information:
Changes to the European Pharmacopoeia 2.6.7 - – Mycoplasma Testing
Featured in this article:
New regulatory requirements, validated products,
and transition rules for mycoplasma detection in cell cultures,
biopharmaceuticals, and ATMPs.
From April 2026, the revised European
Pharmacopoeia (EP) 2.6.7 will become mandatory. Edition 12.2 defines,
for the first time, a dedicated framework for nucleic acid amplification
techniques (NAT) and specifies requirements for validation.
Key Changes:
- NAT now has its own regulatory framework and is considered equivalent to culture-based methods.
- Required limit of detection (LOD) when NAT replaces culture or indicator cell culture: ≤ 10 CFU/mL or < 100 GC/mL.
- Genomic copies (GC) are introduced as a unit optimized for NAT methods.
- Both culturable and non-culturable mycoplasmas must be detected.
- Cells and supernatant should be tested whenever possible, as mycoplasmas may adhere to or reside within cells.
- Clear requirements for method validation using validated commercial kits in the user’s own product matrix.
- More detailed specifications for reference materials and standards, including:
- GC:CFU ratio < 10
- Improved comparability between NAT and culture methods.
- Mandatory NAT controls:
- Internal control to rule out inhibition (ideally added before pretreatment/extraction)
- External positive control with defined GC or CFU content close to the limit of detection
- Negative control without target sequence
These changes affect QC laboratories,
biopharmaceutical manufacturers (including ATMP and CGT), and all
facilities applying NAT-based mycoplasma detection methods validated
under the previous EP 2.6.7.
For You as a User, this Means:
- Existing methods must be reviewed and revalidated.
- New products must be validated in accordance with EP 2.6.7 (Edition 12.2).
- The transition period should be used to plan and conduct product-specific validation activities.
Minerva Biolabs has revised all relevant products and developed new kits fully aligned with EP 2.6.7 (Edition 12.2).
Your Benefits:
- No risk from non-compliant kits
- Reliable detection even in complex matrices
- Seamless integration into existing workflows
- Fully documented validation for regulatory and audit purposes
Products:
Key Updates:
- Regulatory foundation: Compliant with EP 2.6.7 (Edition 12.2), USP <63>, USP <77> (draft), and JP 18 G3.
- Detection principle & sensitivity:
Reverse transcriptase-based assays detect both DNA and RNA, enhancing
analytical sensitivity.
- Sensitivity per EP: ≤ 10 CFU/mL or < 100 GC/mL
- Reliable detection even with low copy numbers or partially degraded DNA/RNA
- Extended specification: Incorporation of
TaqMan® probe technology ensures maximum specificity and
reproducibility, effectively minimizing cross-reactivity and false
positives.
- Broad detection range: Detects >130
mycoplasma species, including all species listed in the relevant
pharmacopoeias (EP 2.6.7, USP <77> draft, JP 18 G3) across
mycoplasma, acholeplasma, and spiroplasma species.
The new Mycoplasma Standards are fully aligned
with EP 2.6.7 (Edition 12.2) and provide a traceable, reproducible, and
reliable foundation for validation and quality control of NAT-based
detection methods.
- Regulatory compliance: Fully compliant with EP 2.6.7 (Edition 12.2) and harmonized with USP <77> (draft) and JP 18 G3.
- EP-compliant production: Cultures harvested
during the exponential growth phase; characterized by a GC:CFU ratio
< 10, a key quality criterion for reference materials.
- LOD determination: Designed for limit of
detection (LOD) verification and product-specific validation according
to the current pharmacopoeia.
- Non-infectious and safe: Suitable for quality control, in-process control, and use in GMP environments.
- External positive control: Meets the new EP requirement for regular sensitivity verification of validated NAT methods.
Products:
100GC® Mycoplasma Standards
Key Improvements:
- New reference unit: 100 GC/mL, equivalent to 10 CFU/mL according to EP 2.6.7.
- Traceable quantification: Precisely
quantified using digital PCR (dPCR); genomic copy number stated in the
Certificate of Analysis (CoA).
Products:
10CFU® Mycoplasma Standards
100CFU® Mycoplasma Standards
Key Improvements:
- Defined GC/CFU ratio: GC:CFU < 10 in line with current pharmacopoeial requirements.
- Traceable quantification: Determined via dPCR; GC:CFU ratio reported in the CoA.
3.3) Robust and Validated Extraction Systems
The Venor® Mycoplasma Extraction Kit was
validated in combination with the new Venor® Mycoplasma Assays. It
provides robust, reproducible, and efficient nucleic acid extraction for
mycoplasma detection in biopharmaceuticals, cell cultures, and ATMPs.
Product:
Venor® Mycoplasma Extraction Kit
Key Features:
- Magnetic bead technology: Ensures high DNA yield and purity – ideal for demanding matrices.
- Manual or automated use: Compatible with both manual workflows and automated high-throughput systems (e.g., KingFisher™ Flex).
- Regulatory compliance: Fully EP 2.6.7-validated in combination with the Venor® Mycoplasma Assays.
Some legacy products will be phased out, as they no longer meet the new EP requirements.
Minerva Biolabs offers an internal transition
period until April 2029, during which these kits remain available for
planned validations.
(Note: The regulatory compliance deadline is April
2026.)
Products Affected:
- Venor®GeM Classic
- Venor®GeM qEP
- 10CFU™ Sensitivity Standards (previous version)
- 100CFU™ Sensitivity Standards (previous version)
Stay informed and register for our Notification of Change service.
We support you with:
- Selection of EP-compliant kits
- Conducting product-specific validation
- Adaptation of existing validations
- Documentation for regulatory authorities and auditors
Technical Support:
suppor@cambio.co.uk