Mycoplasma Testing

Cell substrates used in the manufacture of biologics must be shown to be free of adventitious agents including mycoplasma. Mycoplasma contamination of cell lines can affect cell growth in culture and also influence the production yields of biomolecules.

The mycoplasma testing methods developed at Charles River comply with different compendial guidelines outlined by multiple global regulatory authorities. If a product is being released into multiple regulatory environments, single methods have been developed to satisfy more than one guideline in order to decrease costs and material consumption. Product-specific method development and consultation is also available.

Mycoplasma Testing Services

  • Quantitative Fluorescence PCR (QF-PCR), including protocols with broth enrichment steps
  • Individual protocols meeting PTC, EP, JP or USP requirements
  • EP/USP harmonized protocol
  • EP/USP/JP harmonized protocol
  • EP/USP/PTC harmonized protocol
  • Mycoplasma detection by the large volume method
  • Mycoplasmastasis
  • Spiroplasma QF-PCR, for products that have been in contact with plant or insect materials
  • Mycoplasma clearance studies

If you need the results of your testing expedited, Fast Track Testing is available for our mycoplasma, sterility and adventitious virus testing assays. Learn more »

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We work with you to evaluate your QC testing programs by reviewing your current testing structure and selecting the appropriate mix of insourcing and outsourcing options.

Release Testing

Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets.

Fast Track Testing

In response to our customers’ need for rapid testing results, Charles River is pleased to announce Fast Track Testing for mycoplasma, sterility and adventitious viral assays.