Enhancing Viral Clearance Prediction And Process Optimization With MockV Technology

Ensuring viral safety is a foundational requirement in biopharmaceutical development, but traditional viral clearance studies—typically conducted late in the process using infectious viruses at external CROs—come with significant limitations. These studies are costly, offer little flexibility for process optimization, and often assess only a narrow set of process parameters. As a result, opportunities for early intervention and process refinement are missed, and developers may encounter unforeseen issues late in the manufacturing timeline.

To overcome these limitations, an innovative approach using MockV technology has been introduced. MockV uses non-infectious retrovirus-like particles (RVLPs) to simulate viral contamination, enabling in-house testing earlier in downstream process development. This early-stage assessment provides valuable data on viral clearance capacity without the safety risks and delays associated with handling infectious viruses. By using MockV, developers can identify inefficient process steps, improve robustness, reduce reliance on external testing, and achieve meaningful cost savings. Discover how to accelerate development and enhance viral safety in your manufacturing strategy.