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
- 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
- Purification process
- Manufacturing processes using animal- or human-derived products
- 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
Sartobind® Q strong ion exchangers are perfect tools for the polishing of monoclonal antibodies for the removal of viruses, DNA, host cell proteins, leached Protein A, and endotoxins. As size exclusion effects are neglectible, they are suited for purification of viruses such as adeno or lentiviruses displaying one order of magnitude higher dynamic binding capacity.
Sartobind STIC® PA (primary amine) anion exchange membrane overcomes reduced binding capacity for host cell protein removal and can be used in high-salt conditions.
Sartobind® Rapid A is provided as ready-to-use devices which will be fully utilized within a single batch and afterwards disposed:
- >150 g/L*h productivity
- >30 g/L DBC 10% at 12 sec RT
- Average cycle times of only 10-15 min
Sartobind® S membrane adsorber units combine the advantages of convective media and ion exchange chromatography for rapid and easy contaminant removal or capture of virus and virus like particles.
First virus retentive filter for cell culture media.
Protect your cell culture media from virus contaminations with the 20 nm high flux PES Virosart® Media. The filter retains ≥ 4 LRV for small non-enveloped viruses like MVM or Vesivirus and ≥ 6 LRV for large enveloped viruses.
Maximize your virus filter performance with adsorptive pre-filtration. Virosart® Max is a specifically optimized virus pre-filter significantly increasing downstream virus filter performance.
The PES based virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in biopharmaceutical applications. Virosart® CPV is the optimal virus filter for monoclonal antibodies or small recombinant proteins.
The high capacity virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in blood & plasma applications.
High speed virus filtration.
The high flux PES based virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in biopharmaceutical applications.