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Provise™ Clearance Services

Our process scientists and project managers can handle your virus inactivation and removal operations at our facilities, with seamless tech transfer and a Final Report to support your filing

Our Provise™ Clearance Services can deploy a team of highly trained process scientists and study directors on your behalf, performing all your required process steps at our state-of-the-art facilities. You’ll be kept informed at every step without the need to leave your workplace, maximizing your own productivity while being assured of a QA-audited Final Report that will expertly support your regulatory filing.

Our dedicated team can leverage extensive experience in:

  • Virus reduction filtration
  • Column chromatography
  • Column re-use studies
  • Ethanol fractionation
  • Viral inactivation by treatment with solvent/detergent and extreme pH

Our integrated team will conduct a technical to ensure a successful study. Together they will work to:

  • Host technical discussions in order to understand your process
  • Prepare workbooks, study design, and AKTA programs
  • Perform cytotoxicity, mock runs, and process steps

To discuss your clearance needs with an expert, use our reply form and get in touch today.

Working together to deliver your viral clearance study

Your dedicated process team will perform all viral clearance steps on your behalf, keeping you up to date with progress of your study. You will receive a final report and support through your regulatory journey, all while you are doing value-added work within your own facility.

Designing your study

  • Complete the questionnaire
  • Decide execution model for viral clearance study
  • Schedule the slot
  • Finalize study design
    • Executing your study
    • Finalize technical documents
    • Technical transfers
    • Complete pre-study activity i.e., Cytotoxicity & Spike recovery
    • Complete main study i.e., Chromatography & VRF (Virus Reduction Filtration)
      • Finalizing your study
      • Process & log reduction data compiled
      • Peer & Quality review
      • Delivery of final report
      • Feedback survey

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