A Proven Dual Virus Spike Approach for Efficient Viral Clearance Studies
Information
Viral clearance studies are essential for biopharmaceutical safety and regulatory compliance. However, traditional single-virus testing is slow, costly, and resource-intensive. KBI Biopharma and Texcell North America developed a proven dual virus spike approach to streamline these critical studies. The method spiked two viruses (XMuLV and MMV) simultaneously in the same load, processed over the unit operation being evaluated, and quantified clearance using virus-specific assays. This proven approach reduced viral spiking study timelines by 50%, equipment and material costs by 28%, and material requirements by approximately 30% compared to traditional testing. By removing barriers that slow drug development, this approach helps biopharmaceutical developers develop treatments for the patients who need them faster and more efficiently.
