Informative Articles New mycoplasma testing requirements – what labs need to know
The European Pharmacopoeia Commission (EPC) has adopted a revised general chapter 2.6.7 Mycoplasmas together with eleven updated monographs. In short: mycoplasma testing in cell culture and biopharmaceutical production is moving to a more flexible but risk-based approach.
What this means in practice:
Both culturable and non-culturable mycoplasmas must be covered – either through the combination of classical culture and indicator cell culture, or by applying a validated NAT method supported by risk assessment and regulatory approval.
The section on nucleic acid amplification techniques (NAT) has been extensively revised to reflect current scientific and technological standards.
A newly defined sensitivity acceptance criterion for NAT reference preparations has been introduced, ensuring greater reliability of results.
Additional adjustments in monographs clarify testing conditions and reduce prescriptive instructions, allowing more flexibility within a controlled framework.
Implementation timeline: Publication in Ph. Eur. edition 12.2 (October 2025), mandatory as of April 1, 2026.
For laboratories, the revision of chapter 2.6.7 mainly means reviewing existing SOPs, providing staff training, and ensuring alignment with quality assurance. A complete revalidation of already established NAT methods is generally not required. Instead, it is about confirming through a risk assessment that the methods in use continue to meet the new requirements. This keeps the additional effort manageable while ensuring state-of-the-art mycoplasma control in line with current scientific and technological standards.
Informative Articles How to Eliminate a Mycoplasma Contamination?
Mycoplasmas are among the most persistent and dangerous contaminants in cell culture and biopharmaceutical production. Because of their tiny size and lack of a cell wall they slip past routine light microscopy. The effects, however, are dramatic: they change cell metabolism and gene expression, slow down growth, reduce transduction efficiency, and in biopharma even compromise product quality, regulatory approval and patient safety.
Once detected, the situation is critical. In many cases, the only option is to discard the culture entirely. A targeted treatment to eliminate mycoplasma is therefore often the very last chance to rescue valuable cells before they are lost for good.
We explore this dilemma and the strategies to overcome it in our latest blog post.
Product Highlights When Mycoplasma Join the Culture
Even the most carefully maintained cell culture is not immune to sudden setbacks: mycoplasma contamination can remain hidden for weeks, undermining results and threatening valuable projects.
Mynox® was developed precisely for this scenario. Instead of discarding affected cultures, researchers can rely on a targeted treatment that eliminates existing mycoplasma and helps preserve both the cells and the work invested in them.
With its proven efficacy and easy application, Mynox® provides a practical option to secure ongoing research and protect future outcomes.
Use waterproof fine-tip markers to label bottles and tubes. Faded or smeared labels can quickly cause mix-ups leading to cross-contamination, incorrect results, or, in the worst case, the loss of entire experiments.
