On 12 December EMA published the draft of "VICH GL34: Biologicals: testing for the detection of mycoplasma contamination". This draft is open for consultation until 12 March 2012.
Today the regulations in Japan, Europe and US described in Japanese “Minimum requirements of biological products for animal use (2002)”, the European Pharmacopoeia (7th Edition, 2011, 2.6.7), and the United States Code of Federal Regulations, Title 9, 113.28 require methods for testing for Mycoplasma contamination. All three recommend methods using a broth and agar technique, but they 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."
The guideline comprises two test methods, the first with expansion in broth culture and detection by colony formation on nutrient agar plates; and the second with expansion in cell culture and characteristic fluorescent staining of DNA (a technique capable of detecting non-cultivatable strains). NAT-based methodology is not included in this guideline, but it is acknowledged and the use of validated NAT techniques is currently approved or under consideration by regulatory authorities for more rapid detection confirmation and strain identification. Validates NAT methods may be used as an alternative test to the recommended broth and agar methods.
Please see the complete guideline draft "VICH GL34: Biologicals: testing for the detection of mycoplasma contamination" for further details.
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)