This webinar provides a comprehensive view on the regulatory guidance and practical strategies for designing viral clearance studies. These include appropriate scale-down of unit operations, virus spike-related considerations and validation (clearance evaluation) of manufacturing process steps. Essential elements of a developmental phase-appropriate viral clearance package are discussed.
Virus Safety Of Biopharmaceuticals: Risk Mitigation During Upstream And Downstream Operations
Summary: From a virological safety standpoint, biopharmaceuticals have had an excellent safety record. This can be attributed to regulatory and industry initiatives that have worked synergistically. Viral clearance studies to document an adequate safety margin are a key component of risk management to reduce the potential for iatrogenic transmission of pathogenic viruses. While the regulatory approach to viral safety is well established, specific application is determined by a risk assessment that includes considerations such as product type, indication and the stage of product development. Virus contamination events are rare; however, they can be catastrophic when they occur. Consequently, current industry trends are focused not only on downstream unit operations for risk management but also upstream risk mitigation approaches.