Regulatory Mycoplasma Testing

Detection of mycoplasma contamination is a key component of quality control in biopharmaceutical and ATMP manufacturing.

The new Venor® Mycoplasma RT-PCR assays are nucleic acid amplification technique (NAT)-based methods, fully aligned with the revised European Pharmacopoeia (EP) 2.6.7, Edition 12.2.

Highlights:

• Compliant with EP 2.6.7 (Edition 12.2), USP <63>, USP <77> (draft), and JP 18 G3
• Reverse transcriptase PCR for maximum sensitivity
• Detection of both DNA and RNA
• TaqMan® probes ensure the highest specificity and reproducibility
• Detection of >130 Mycoplasma species, including all species listed in the pharmacopoeias
• Lyophilized components for simplified handling, transport, and storage
• Compatible with qPCR, dPCR*, and gel-based conventional PCR*
• Precisely quantified reference materials with digital PCR (10CFU® -, 100CFU® -, 100GC® Mycoplasma Standards) for sensitivity verification and external positive control
• Fully validated system: compatible with the Venor® Mycoplasma Extraction Kit

Why Mycoplasma Testing Is Essential

Mycoplasmas are the smallest self-replicating bacteria and can infect a wide range of cell cultures. Contamination not only compromises product quality but may lead to production losses, product recalls, or even patient safety risks.

For this reason, the current pharmacopoeias require the use of validated mycoplasma test methods as part of the quality control process.

NAT-based methods offer key advantages:

• Highest sensitivity and specificity
• Rapid results compared to culture-based methods
• Detection of both culturable and non-culturable mycoplasmas

Our Solution for Regulatory Compliance

The new Venor® Mycoplasma product line has been validated in full accordance with the updated requirements of EP 2.6.7, including determination of the limit of detection (LOD) (≤ 10 CFU/mL and < 100 GC/mL), robustness, and specificity. These assays are ideally suited for quality control, in-process control, and product release in GMP-regulated laboratories.

Learn more about all products and the new regulatory requirements according to EP 2.6.7 on our information page:
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