Virus Clearance Services

Confidence® Validation Services provide GLP and non-GLP virus clearance studies for any purification technology, as well as expert consultation.

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Virus-Clearance-Services
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

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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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

  • Sartobind® Q
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    M_Sartobind_Q

    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
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    M_Sartobind_STIC_PA

    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
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    M_Sartobind_Rapid_A

    Sartobind® Rapid A is a ready-to-use membrane chromatography system designed for purifying monoclonal antibodies. It works with any chromatography setup and is scalable for capturing Fc-containing biomolecules, such as mAbs and Fc-fusion proteins, aiding in process intensification.

  • Sartobind® S
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    M_Sartobind_S

    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.

  • Virosart® Media
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    M_Virosart_Media

    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.

  • Virosart® Max
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    M_Virosart_Max

    Maximize your virus filter performance with adsorptive pre-filtration. Virosart® Max is a specifically optimized virus pre-filter significantly increasing downstream virus filter performance.

  • Virosart® CPV
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    M_Virosart_CPV

    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.

  • Virosart® HC
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    M_Virosart_HC

    The high capacity virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in blood & plasma applications.

  • Virosart® HF
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    M_Virosart_HF

    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.