Biopharmaceutical industry using mammalian cell lines for production of a
biotechnology product are running the risk of viral contamination. Eurofins Sinensis, fully GMP certified, offers the classic in vitro assay to detect adventitious viruses in cell lines/banks, virus seeds, raw materials and final products.
Is your cell bank free of adventitious agents?
Viral contamination is a major concern affecting batch release and product safety. During the production process, adventitious viruses could accidentally be introduced, for example, by using contaminated cell culture media or reagents. Other common sources are contamination caused by operators or other external factors.
What products should be tested?
- Monoclonar antibodies
- Master cell bank
- End of production cells
- Unprocessed bulk
- Vector supernatant
Available viral assays
All assays performed in-house are fully validated according to ICH Q2:
- In Vitro Assays (multiple cell lines are available for Mouse-, Hamster-, Bovine-, Insect- and Humanderived products)
- In Vivo Assays (these assays are subcontracted to an approved vendor)
- Bovine Viral Assay (according to 9 CFR 113)
- Porcine Viral Assay (according to 9 CFR 113)
- qPCR Assays
- XC Assay for Ecotropic Retroviruses
- S+ L- Assay for Xenotropic Retroviruses
- Electron Microscopy for Microscopy for Evaluation of Cell Banks and Culture Harvests
- Co-Cultivation Assays
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.