Guideline on Testing for the Detection of Mycoplasma Contamination of veterinary medicinal Products

In December, the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) published the draft of VICH GL34: Guideline on testing for the detection of mycoplasma contamination for further consultation. The deadline for comments is 31 March 2011.

As for biological medicinal products for human use it is also important for biologicals for veterinary use that they are free of contamination with mycoplasma to help assure consistency of production and final product safety. Mycoplasma contaminants could be introduced into cell culture and in ovo origin biological products through the master seeds, the master cell seed (stock), starting materials of animal origin, and in processing of biological materials during passage and product assembly. Therefore it is necessary to demonstrate through testing that Mycoplasma are not present, within the limits of the test, in the final product, working seeds and cells and harvests, and starting materials such as the master seed, master cell seed, and ingredients of animal origin.

The European Pharmacopoeia, the Japanese Regulations and the US Code of Federal Regulations all require testing for Mycoplasma contamination using a broth and agar technique. The requirements do however differ in the specifics of these broth and agar tests as well as other alternative test methods that are required or approved for use in detecting Mycoplasma contamination.

This guideline establishes stages of manufacture to be tested and test procedures to detect the presence of Mycoplasma contamination. It will provide a unified standard that will facilitate the mutual acceptance of test data by the relevant regulatory authorities. Methods proven equivalent to the guideline method by scientifically accepted criteria could also be acceptable.

It describes the manner in which tests conducted to detect the presence of Mycoplasma contamination in cell culture and in ovo origin biological products for veterinary use shall be done to assure the absence of Mycoplasma contamination. Tests on master seeds, master cell seeds (stocks), working seeds and cells, ingredients of animal origin, harvests and live final vaccine and harvests for killed products are included.

Two test Methods are the content of this draft:
1) Expansion in broth culture and detection by colony formation on nutrient agar plates; and
2) Expansion in cell culture and characteristic fluorescent staining of DNA (a technique capable of detecting non-cultivatable strains).

The use of the polymerase chain reaction (PCR) is currently under consideration by regulatory authorities for more rapid detection in broth and cell cultures, confirmation, and strain identification. Its use is encouraged in parallel testing to further develop, compare, and refine the technique for possible inclusion in future versions of this guideline.

Please also see the complete guideline for more detailed information.

For current information about Mycoplasma Testing, please note the "European Mycoplasma Testing Conference" in combination with the "European Microbiology Conference" in Prague, Czech Rebublic, from 3 to 5 May 2011. Speakers from different scopes of pharmaceutical microbiology, from regulatory bodies and consulting will give you the chance to get to know the different views and experiences in Mycoplasma Testing. 

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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