Tailoring Viral Clearance Study Design to Regulatory Requirements and Real-World Demands

This white paper draws directly from Minaris Advanced Testing’s long-standing experience executing viral clearance studies. We examine how to design viral clearance studies that balance scientific rigor with operational efficiency. By highlighting common pitfalls and illustrating how modality-specific considerations shape virus panels, we aim to provide developers with practical, regulatorily aligned best practices for efficient, successful viral clearance studies.