2 General Overview of Viruses Brief Discussion of Viruses Virus Contamination of Biologicals - Historical Perspective and Lessons Learnt Products Requiring Viral Safety Assessment
3 Control of Production Processes for Viral Safety General Considerations Raw Materials Cell Bank Production Characterization and Validation Adventitious Contaminants
4 Virus Detection Methods General Types of Viral Detection Assays Summary Comments
5 Regulatory Considerations: A Risk Based Approach to Viral Safety General Considerations Risk Assessment Risk Minimization Risk Management: How Much Viral Clearance is 'Enough'? Summary Comments
6 Virus Clearance Methods General Considerations Virus Clearance Methods - Serendipitous Versus Deliberate Virus Clearance Methods - Inactivation and Removal Virus Removal Methods
7 Process Validation for Viral Clearance General Considerations Viral Clearance Evaluation (Validation) Studies Virus Stock-related Considerations Importance of Adequate Controls Considerations in Data Interpretation and Estimating Viral Clearance Viral Clearance Validation Studies: Pitfalls and Cautions Summary Comments
