Virus Clearance Services

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

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<h3>Benefits</h3>

• <b>Fast Turnaround</b><b>: </b>Thanks to optimized project management to complete studies rapidly, with 9-week turnaround times for a typical GLP phase I study
• <b>Highly Purified Viruses: </b>We use highly purified viruses for all removal and inactivation steps to achieve the highest possible log reduction values
• <b>Proven Experience</b><b>:</b> Our Confidence® team brings more than 50 years of experience and 700 completed projects to every virus clearance study
• <b>Customer-Focused Services:</b> We perform virus clearance studies remotely at no extra cost, eliminating the need to travel to the spiking facilities
• <b>Consolidated Solutions:</b> With Sartorius, biopharma customers get everything under one roof: virus clearance consumables and virus clearance validation services

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Applications

• Purification process
• Manufacturing processes using animal- or human-derived products

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Services

• GLP phase I studies
• GLP phase III studies
• non-GLP feasibility studies
• <b>Viruses available:</b> HSV-1, MuLV, MVM, PPV, PRV, Reo-3, BVDV, HAV
• <b>Purification methods:</b> S/D and low pH inactivation, Chromatography (Membrane Adsorbers, Resins, Monoliths), Virus filtration, Other inactivation steps on request