Virus clearance studies are an essential step to get a biologic to the market. The goal of such studies is to verify how well a particular purification procedure removes or inactivates viral contamination. When Vitus Clearance studies are poorly designed, however, they can lead to low log reduction values (LRV) — and questions from regulators
.
Benefits
- Fast Turnaround: Thanks to optimized project management to complete studies rapidly, with 9-week turnaround times for a typical GLP phase I study
- Highly Purified Viruses: We use 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 50 years of experience and 700 completed projects to every virus clearance study
- Customer-Focused Services: We perform virus clearance studies remotely at no extra cost, eliminating the need to travel to the spiking facilities
- Consolidated Solutions: With Sartorius, biopharma customers get everything under one roof: virus clearance consumables and virus clearance validation services
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: HSV-1, MuLV, MVM, PPV, PRV, Reo-3, BVDV, HAV
- Purification methods: S/D and low pH inactivation, Chromatography (Membrane Adsorbers, Resins, Monoliths), Virus filtration, Other inactivation steps on request
