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Virus Clearance Studies

altVirus clearance studies remain one of the key pillars of the safety tripod for ensuring product safety, and for many products may represent the main avenue for ensuring the safety of the product. The design and implementation of virus clearance studies,therefore, remains an area of close scrutiny during regulatory review of submissions.

All ViruSure clearance studies address all issues frequently questioned by regulatory agencies including:

  • Interference testing of sample matrices (including virus recovery and interference at low virus concentrations)
  • Assay validation
  • Hold control samples
  • Kinetics of inactivation (for inactivation processes)
  • Appropriate downscaling of the process
  • Mass balance
  • Virus aggregation (particularly for filtration processes)
  • Column re-use
  • Virus strain and identity (full documentation of the origin of the strain is important)

altThe ViruSure team has been involved in the design and implementation of virus clearance studies for the last 15 years, and represents a cumulative experience exceeding 50 years. ViruSure has actively participated in a number of regulatory workshops on virus clearance issues, and the CEO, Dr Andy Bailey has served on numerous occasions as an invited speaker at closed regulatory workshops.

ViruSure is able to support you with discussions with regulatory agencies in relation to study design or interpretation of data.

For more information, please download our Fact Sheet on virus clearance studies here.

You can also get in touch with us here

Virusure GmbH

Donau-City-Straße 1, A-1220 Vienna, Austria.
Phone: +43-(0)1-2699120
Fax: +43-(0)1-2699120/22