Eurofins Sinensis, fully GMP certified, has more than 20 years of experience in detection and control of mycoplasma and other mollicutes, offering a wide variety of testing and validation services.
Is your cell bank free of Mycoplasma?
Mycoplasma are the most common contaminant in the biopharmaceutical industry, affecting batch release and product safety. Mycoplasma, Spiroplasma and other mollicutes can pass through sterilising grade filters due to their flexible shape and small size, and require specialised techniques and media for their detection. 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 Sinensis 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)
- Disinfectant efficacy testing
- Process inactivation validation
Did you know that?
- Our mycoplasma division has over twenty years 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 contact us to find out whether we can help. Our research team will be happy to assist in planning your study.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.