Maximizing Results For Viral Clearance Studies

In the Eurofins Biopharma Product Testing webinar, presenters Noah Horn and Alex Rodriguez shared in-depth strategies to maximize viral clearance (VC) study success, focusing on virus strain selection, titer optimization, and process design. As regulatory standards grow increasingly stringent across regions and product phases—from IND to BLA—early planning is critical. The session emphasized that selecting the right model viruses depends on product origin, development phase, and target regulatory body, with different requirements for CHO, HEK-293, or plasma-derived products.

The presentation outlined key considerations such as using orthogonal clearance mechanisms across multiple process steps, optimizing spike concentrations and virus titer to achieve required log reduction values (LRVs), and designing worst-case conditions (e.g., low pH, high load density) to validate robustness. High-titer, high-purity virus lots improve challenge potential while minimizing interference with process performance. The speakers also discussed cytotoxicity and interference testing, scaled-down validation models, and the need for thorough documentation and communication to ensure study integrity.

Emphasis was placed on proper planning of sample volumes, buffer requirements, and extra material to accommodate potential reruns. Eurofins supports flexible service models—from client-led runs to full-service execution—while maintaining strict quality standards.

The session concluded with a Q&A addressing common industry concerns such as FDA vs. EMA expectations, process step selection, and achieving 6-log or 20-log reductions. Overall, the webinar reinforced that well-executed viral clearance studies not only meet regulatory demands but also ensure patient safety—making them a foundational element of biologics development.