Biopharmaceutical industry using mammalian cell lines for production of a biotechnology product are running the risk of viral contamination. Eurofins BioPharma Product Testing Netherlands, 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?
- Monoclonal 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:
Adventitious Viruses
- In Vitro Assays (multiple cell lines are available for Mouse-, Hamster-, Bovine-, Insect- and Human derived products)
- In Vivo Assays (these assays are subcontracted to an approved vendor)
Specific Viruses
- Bovine Viral Assay (according to 9 CFR 113)
- Porcine Viral Assay (according to 9 CFR 113)
- qPCR Assays
Retrovirus 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
- PERT
Test in primary chicken cells for egg-based vaccine products
- Avian Adenoviruses: AAV1 & Egg-drop syndrome
- Electron Microscopy for Microscopy for Evaluation of Cell Banks and Culture Harvests
- Co-Cultivation Assays
- PERT
Customised services, examples
- Virus or vector titration assay (TCID50)
- Viral or vector infectivity assay
- Genome copy titration by qPCR or ddPCR
- Vector identity qPCR or ddPCR
- Potency assay
- Vector sequencing
- Replication competent viral vector assay
Do you require customised services? 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.
