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, 21 CFR 610.30, PTC, USP chapter <63>)
- Indicator cell (DAPI) (EP 2.6.7, 21 CFR 610.30, PTC, 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)
Inactivation studies
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 find out whether we can help. Our research team will be happy to assist in planning your study.
Why choose Eurofins BioPharma Product Testing Netherlands
- Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertise within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multidisciplinary organization.
- Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions.
Please contact us if you want to discuss your needs.
