Virus Clearance Services

Virus clearance studies are an essential step to get a biologic into clinical trials and ultimately to market. The goal of these studies is to evaluate the ability of a downstream unit operational step to inactivate or remove viral contamination and provide assurance of the virus safety of the drug product. Sartorius offers GLP as well as non-GLP virus clearance studies and provide consultancy on study design and regulatory requirement.

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