Virus Clearance Services
- Item No.:
- Virus-Clearance-Services
Choose your Confidence® Validation Services
Benefits
- Fast Turnaround: Thanks to optimized project management, GLP Phase 1 studies are completed rapidly, with 9-week turnaround times
- Highly Purified Viruses: We use single level highly purified viruses for all removal and inactivation steps to achieve the highest possible log reduction values.
- Proven Experience: Our Confidence® team brings more than 60 years of experience and 700 completed projects1 to every virus clearance study.
- Customer-Focused Services: Single Point of Contact & perform Virus Clearance Studies remotely at no extra cost, eliminating the need for a sponsor to travel to our test facilities.
- Technical & Regulatory Support: Access to Sartorius technical experts across Process Consultancy, Regulatory Affairs and Technical Specialists
- Holistic Solutions: With Sartorius, biopharma customers receive a comprehensive solution, including Downstream Consumables and Virus Clearance Validation Services, all under one roof.
1 - experience gained in Sartorius and at external CRO’s.
Applications
- Purification process
- Manufacturing processes using animal- or human-derived products
Services
- GLP phase I studies
- GLP phase III studies
- Non-GLP feasibility studies
- Viruses available: MuLV, MVM, PPV, PRV, Reo3, SV40, BVDV, EMCV, HAV, HSV-1, PI3
- Purification methods: Solvent | Detergent, Heat Treatment and low pH inactivation, Chromatography (e.g., Affinity, AEX, CEX, HIC, MX, SEC), Virus filtration, and other virus clearance process steps (e.g., pasteurisation) on request
Questions & Answers (5)
Virus clearance is a where we assess a (Biologics) manufacturing process step to inactivate or remove viruses and transmissible spongiform encephalopathy (TSE) agents.
Yes. A Virus Clearance Study is required for all human- or animal-derived drug products (e.g., ICH Q5A R1) and before Clinical Phase 1 | IND Submission and Clinical Phase 3.
We have a range of viruses available to support virus clearance studies for most modalities and applications such as MuLV, MVM, REO3, PRV, SV40, BVDV. More information can be found on our webpage.
Inactivation steps like pH treatment, solvent detergent, or heat treatment inactivate viruses. Virus removal uses chromatography (AEX, CEX, HIC) and virus filtration with retentive filters.
Clearance capacity is measured by Log Reduction Value (LRV), indicating virus removal/inactivation. Viral clearance is the difference in virus amount before and after processing.