Regulatory Mycoplasma Testing
for Biopharmaceuticals and ATMPs
Mycoplasma contamination testing is an essential part of quality control in biopharmaceutical manufacturing, cell therapy, gene therapy, and ATMP production. Reliable detection of mycoplasmas helps protect product quality, prevent production losses, and support patient safety.
Why Mycoplasma Testing Is Essential
Mycoplasmas are among the smallest self-replicating bacteria and can infect a wide range of cell cultures. Due to their small size and lack of a cell wall, they may remain undetected by routine microscopic inspection while still affecting cell growth, metabolism, gene expression, and product quality.
In biopharmaceutical and ATMP manufacturing, mycoplasma contamination can lead to invalid test results, batch failure, product recalls, or potential patient safety risks. For this reason, pharmacopoeial requirements include validated mycoplasma test methods as part of the quality control strategy.
NAT-Based Mycoplasma Detection for Regulatory Compliance
The updated regulatory framework recognizes nucleic acid amplification technique (NAT)-based methods such as PCR, real-time PCR, and digital PCR as powerful alternatives to classical culture-based mycoplasma testing. These methods enable rapid, sensitive, and specific detection of mycoplasma contamination in cell cultures, biological products, and advanced therapy medicinal products.
NAT-based mycoplasma detection offers important advantages for regulated laboratories:
- Highest sensitivity and specificity
- Faster results compared to culture-based methods
- Detection of both culturable and non-culturable mycoplasmas
- Clear framework for modern molecular testing workflows under EP 2.6.7 and USP <77>
Our Solution for Regulatory Mycoplasma Testing
The Venor® Mycoplasma product line provides NAT-based assays for regulatory mycoplasma testing according to the revised European Pharmacopoeia chapter EP 2.6.7, Edition 12.2, United States Pharmacopeia USP <77>, and Japanese Pharmacopeia JP 18 G3.
The assays meet the sensitivity expectations, including a limit of detection of ≤ 10 CFU/mL and < 100 GC/mL, and have been evaluated for specificity and robustness.
Product Highlights
- Compliant with EP 2.6.7 (12.2), USP <77>, and JP 18 G3
- Reverse transcriptase PCR for highest sensitivity through detection of both RNA and DNA
- TaqMan® probes for high specificity and reproducibility
- Detection of more than 130 Mycoplasma species, including species listed in the pharmacopoeias
- Lyophilized components for simplified handling, transport, and storage
- Compatible formats for qPCR and dPCR/ddPCR™ workflows
- Fully validated in combination with the Venor® Mycoplasma Extraction Kit
Reference Materials for Validation and Routine Testing
Precisely quantified reference materials are essential for sensitivity verification, product-specific validation, and reliable routine testing. Minerva Biolabs offers Mycoplasma Standards designed to support EP 2.6.7- and USP <77>-compliant NAT workflows.
- Precisely quantified by dPCR
- Available as 100GC®, 10CFU®, and 100CFU® Mycoplasma Standards
- Manufactured according to EP 2.6.7 requirements
- GC:CFU ratio <10
- Non-infectious
- Derived from native mycoplasma material
- Available for 10 relevant species
- Suitable for product-specific validation and for use as external positive control/extraction inhibition control in routine testing
Together with Venor® Mycoplasma Extraction, Venor® Mycoplasma qPCR/dPCR and Mycoplasma Standards, Minerva Biolabs provides a complete system for NAT-based mycoplasma detection, method validation, sensitivity verification, and routine quality control.
The workflow is suitable for GMP-regulated laboratories performing mycoplasma testing of cell cultures, biopharmaceutical products, cell and gene therapy products, ATMPs, and other cell culture-derived materials.
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