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
- Spiroplasma QF-PCR, for products that have been in contact with plant or insect materials
- Mycoplasma clearance studies