Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements for a developmental phase-appropriate viral clearance package are detailed.
Learn more about:
Scale-down model qualification
Virus spike experiments
Validation (clearance evaluation) of manufacturing process
