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

Strengthening a Critical Safeguard Modern biologics have maintained a strong viral safety record for decades, supported by the “three pillars” of viral safety: material characterization, batch release testing, and viral clearance studies.1,2 While characterization and release testing detect known contaminants, they are limited by the sensitivity of direct detection assays.1 Viral clearance studies are the … Continued