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    Viral Clearance

    Biopharmaceutical or biological products, such as animal tissue-derived products, monoclonal antibodies, recombinant proteins, vaccines and blood derivatives carry an inherent risk of viral contamination.  A viral clearance study is to evaluate the capability of the manufacturing process to eliminate (inactivate and/or remove) any potential viral contaminants from the final product.  It’s a necessary step during the development and manufacturing of a biologics product to ensure viral safety and is required by regulatory agencies worldwide.

    Viral Clearance Brochure

    Study Design

    • Risk assessment of the product regarding viral safety
    • Selection of target viruses to be evaluated
    • Selection and downscaling, if necessary, of process steps to be evaluated
    • Setting up viral reduction goals
    • Preliminary studies on cytotoxicity and viral interference
    • Viral spiking study
    • Results review and discussion, and issuance of final report

    Regulatory Bodies

    • U.S. Food and Drug Administration (FDA)
    • European Medicines Agency (EMA)
    • Health Canada
    • Other International Agencies

    References and Guidelines

    EMEA, CHMP: “Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products”. EMEA/CHMP/BWP/398498/2005 (2008).

    EMEA, CPMP: “Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Virus”. CPMP/BWP/268/95 Final Version 2 (1996).

    EMEA, CPMP: “Guideline on plasma-derived medicinal products”. EMA/CHMP/BWP/706271/2010 (2011).

    FDA/CBER: “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals” (1993).

    FDA/CBER: “Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use” (1997).

    FDA/CDRH: “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)”, Notices 84 FR 9530 (2019).

    ICH Topic Q5A (R1): “Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin”. Step 4 (1999).

    International Standard ISO 22442-3: “Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of virus and transmissible spongiform encephalopathy (TSE) agents”. ISO 22442-3:2007(E).