Table of Contents
1. Executive Summary
2. General Overview
- What are TSEs?
- Spectrum of TSE (Prion) Diseases
- Etiology of Prion Diseases
- Characteristics of the Prion Protein
- Transmissibility:
- Summary Comments
3. Control of Production Processes
- General Considerations
- Evaluation of Raw Materials Used in the Manufacturing Processes
- General Requirements for All Raw Materials (from a TSE-Compliance Standpoint)
- Requirements for Specific Products
- GMP Considerations and TSE Compliance
- Summary Comments
4. Prion Detection: General Comments
- Biological Assays
- Methods Based on PrP Detection
- Surrogates of Infection
- Summary Comments
5. Regulatory Considerations
- Risk Assessment: General Considerations
- Risk Evaluation: Factors for Consideration
- Risk-Benefit Analysis
- Minimization of Risk of Transmitting Animal Spongiform Encephalopathies for Regulated Products
- Manufacturing Process Considerations
- Risk Minimization in Manufacture of Specific Products (plasma-derived medicinal products,
urine-derived medicinal products, iatrogenic exposure)
- Risk Minimization: Specific Products (collagen, gelatin, tallow derivatives, bovine blood
derivatives)
- Risk Management
- Summary Comments
6. Prions: Decontamination and Clearance Considerations
- Prion Clearance - General Considerations
- Prion Inactivation Methods
- Decontamination Considerations
- Prion Clearance Studies
- Summary Comments
7. Process Clearance Evaluation (Validation) for Prion Clearance
- General Considerations
- Considerations in Study Design
- Technical Aspects of Study Design
- Prion Clearance Evaluation (Validation) Studies:
- Considerations in Data Interpretation and Estimating Prion Clearance
- Summary Comments
8. Glossary | 
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