Is your cell bank free of Mycoplasma?
Regulations dictate that each bulk harvest of a bioreactor run is tested for the absence of Mycoplasma.
What products should be tested?
Therapeutic products for both human and animal use are required to be tested for the presence of mycoplasma:
- Cell lines/banks
- Virus seeds
- Fermented samples
- Crude harvests
- Bulk vaccines
- Purified biological products for human use
Available Mycoplasma assays
Eurofins BioPharma Product Testing Netherlands offers the following assays:
Traditional Mycoplasma testing
- Agar and Broth Assay (EP 2.6.7 and USP chapter <63>)
- Indicator cell (DAPI) (EP 2.6.7 and USP chapter <63>)
Semi-rapid Mycoplasma detection
- Hybrid Mollicute Screening assay by qPCR (EP 2.6.7)
Rapid Mycoplasma testing (outsourced within the Eurofins BioPharma Product Testing network of laboratories)
- MycoSEQ assay with Automated DNA extraction (EP 2.6.7)
Did you know that?
- Our mycoplasma division has over twenty years of experience
- Our mycoplasma division was involved in reviewing the current EP method
- We developed our own Mycoplasma media which are highly sensitive for a broad range of Mycoplasma
Custom services are also available. Contact us to discuss your mycoplasma testing needs with our experts.
Why choose Eurofins BioPharma Product Testing Netherlands
- Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
- Complete service portfolio. Leveraging our network of GMP product testing laboratories, we can offer a comprehensive testing service portfolio to our customers.
- Standard and custom solutions. If our standard methods do not meet your needs, our skilled technicians can develop customised testing methods tailored to your specific requirements.
