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Mycoplasma Testing

mycoplasmaCell cultures used in the manufacture of biopharmaceuticals must be tested for Mycoplasma contamination. Mycoplasma contamination does not produce turbidity, but can have adverse effects on cell line characteristics/growth rates and virus production. Certain Mycoplasma species are also classed as human pathogens therefore their presence in a manufacturing process is of serious concern. 

International regulatory guidelines vary slightly in their recommended detection methods. Variations of the following assays are used, all with multiple positive controls. 

Mammalian cell culture

The sample is incubated with monkey kidney cells and is then fixed, stained with a DNA-binding fluorochrome (Hoechst Stain), and evaluated microscopically by epifluorescence for the presence of Mycoplasma.

Broth and agar

Broth flasks are inoculated with the test article and are incubated aerobically. Samples from the broth flasks are sub-cultured on appropriate days onto agar plates.  Plates are incubated under appropriate microaerophilic, anaerobic and aerobic conditions for a period of 7-14 days depending on the regulatory guidance being followed.

Plate agar assays

The sample is inoculated directly on agar plates and incubated under appropriate microaerophilic, anaerobic and aerobic conditions depending on the regulatory guidance being followed. Plates are examined for Mycoplasma no sooner than 14 days post-inoculation.



Mycoplasmastasis is described in the EP guidance, and represents a qualification test to examine the test sample for product-specific inhibitors that can interfere with the growth of Mycoplasma.  Normally this test would be required only once for any given product provided there is no change in the manufacturing process.

Regulatory Compliance

All our Mycoplasma assays at a minimum meet the required regulatory standards. We also offer Mycoplasma testing in accordance with Good Laboratory Practice (GLP).

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Combined Mycoplasma Assay

We now offer a combined assay which meets the requirements of both European Pharmacopoeia section 2.6.7 and the United States Pharmacopoeia <63> mongraph.

For more information please contact us.

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Printed from on 26/06/17 01:11:34 AM

Moredun is committed to promoting animal health and welfare through research and education and is recognized worldwide for its contribution to research into infectious diseases of farmed livestock.