A BSL-1 Approach to Predicting Viral Clearance in Biomanufacturing

BioPharm International speaks with David Cetlin, Cygnus Technologies, about MockV®, a non-infectious virus-like particle (VLP) technology designed to streamline viral clearance testing in biopharmaceutical manufacturing. Cetlin explains how the BSL-1 based approach allows companies to perform these assessments in-house, replacing reliance on costly, CRO-run live viral spiking studies with easy-to-use kits. The conversation also covers data comparability to the XMuLV gold standard, regulatory traction, and which internal teams are best positioned to lead adoption.

KEY TAKEAWAYS

• Learn how MockV's® non-infectious VLP technology allows viral clearance testing to be performed in-house at BSL-1, rather than through live viral studies at CROs.
• Understand how RVLP kit data compares to the XMuLV gold standard retroviral model, based on published third-party research.
• Discover the current regulatory landscape for MockV® data, including its use in place of live virus studies for clinical trial application filings.