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Accelerating Viral Clearance Studies: A Co-Virus Spike Approach

BPI Contributor

November 9, 2023

20 Min View
Accelerating Viral Clearance Studies: A Co-Virus Spike Approach

Date: Nov 9, 2023

Duration: 20 Min

This webcast features: Sandra Meier, Viral Clearance R&D Scientist, Charles River Laboratories.

To determine the safety of biologics, the potential of the manufacturing process to inactivate and/or remove potential viral contaminants is addressed. Therefore, starting material is typically spiked with a single virus solution and then subjected to the removal/inactivation procedure.

For significantly saving resources such as material, time, and manpower, a co-virus spike approach using Murine Leukemia Virus (MuLV) and Minute Virus of Mice (MVM) was tested for its applicability in viral clearance studies.

In this webinar, Charles River will address:

  • The possibility to determine the virus specific clearance capacity of a manufacturing step even under co-spike conditions by quantifying each virus separately.

  • The comparison of log10 reduction factors obtained by chromatography and virus retentive filtration using single virus spike versus co-virus spike approach.

  • The benefits in terms of saving time and resources when applying the MuLV-MVM co-spike in your viral clearance study:

    • Up to 50% savings in chromatography columns, virus retentive filters, and process intermediates.

    • Up to 50% time reduction for viral spiking runs.

    • Up to 45% cost savings in process performance costs when CRL performs the process.

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