Revision of Chapter 2.6.7 of the European Pharmacopoeia published for Comment

Chapter 2.6.7 of the European Pharmacopoeia was already introduced in 2006 and came into force in 2008. Apart from a minor revision in 2011, it has remained otherwise unchanged. Although there have been changes in other directives, e.g. in the field of veterinary medicinal products with "VICH GL34: Biologicals: testing for the detection of Mycoplasma contamination" in 2013 or developments such as the first World Health Organization international standard for mycoplasma DNA for nucleic acid amplification technique-based assays designed for generic mycoplasma detection", 2.6.7. has remained unaffected for a long time.

Revision

For this reason, the chapter has now been extensively revised to reflect current practice and the state of the art in science and technology. Changes have been made in several areas, some of which are highlighted below.

In the introductory section, there have been some relevant changes to provide general comprehensive information that applies to the rest of the chapter. For example, a paragraph was added to clarify that 2.6.7. is not limited to the study of the genus mycoplasma in the strict sense, but also includes the class "Mollicutes", with a focus on the study of mycoplasma, ureaplasma, acholeplasma and spiroplasma (using NAT-based methods). Furthermore, it has been clarified that the methods described are suitable for the detection of mollicutes in mammalian cell lines, but are not suitable for the detection of contaminants in insect or plant cell lines.
Further changes in the introduction concern the combination of methods, their selection according to a risk assessment and further items.
In addition, changes or additions were made in the sections on:

• Culture method
• Indicator cell culture method
• Nuclear amplification techniques (NAT)
• Validation of nucleic acid amplification techniques (NAT) for the detection of mycoplasmas: Guidelines

This guidance needed to be substantially revised to bring its content in line with the current state of science and technology. In addition, changes to the existing text were proposed where clarification/modification was needed.

The draft revision can be viewed, after registration, on the EDQM/Pharmeuropa website.