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Handbook Process Chromatography: Optimization, Scale-up, and Validation 1 冊 18112156 販売終了

詳細情報

項目

  • 目次

Preface

1. Biopharmaceuticals Today
　Industrial Context
　Overview of Biopharmaceutical History
　Biopharma Business Environment
　Key Business Issues
　Process Chromatography within an Industrial Context
　Summary

2. Process Capability and Production Scenarios
　Process Capability
　Production Setups
　Process Capability Conclusions

3. Process-Design Concepts
　Typical Process Design for Biopharmaceuticals
　Management Framework for Process Design
　Production Cells and Typical Product Characteristics
　Risk Analysis and Risk Mitigation
　Downstream Processing
　Selected Downstream Processing Platform Examples
　Characterizing the Process, Process Understanding

4. Separation Technologies
　Introduction
　Recovery
　Purification
　Equipment
　Selection Tools from R&D to Production

5. Analysis
　Introduction
　Proteins
　Nucleic Acid Products
　Comparability
　Setting Specifications and Reference Standards
　Method Validation
　Process Analytical Technologies（PAT）

6. Cleaning and Sanitization
　Introduction
　Cleaning
　Decontamination of Transmissible Spongiform
　Sanitization

7. Validation
　Introduction
　What to do When?
　Validation of Downstream Processes
　Making Changes
　Summary
　Acknowledgements

8. Economics
　Economics: An Educational Excursion
　LEAN Manufacturing, Removal of Unproductive Activities
　Cost Model: Monoclonal Antibody Downstream Process
　Cost Improvement Options
　Impact from R&D, Platform Strategies and Technology Outlook
　Conclusions, the Improvement Hierarchy

9. Basic Properties of Peptides, Proteins, Nucleic Acids and Virus Particles
　Introduction
　Peptides
　Proteins
　Nucleic Acids
　Viruses

10. Optimization of Chromatographic Separations
　Introduction
　Basic Relationships
　Purification Principles
　Adsorption
　Elution Modes
　Bed Configuration
　Experimental Determination of Basic Parameters
　Modeling of Chromatographic Purifications
　Simulation of Separations

11. Equipment
　Guidelines for Selecting Pilot Plant and Production Chromatography Equipment
　Selection of Components
　Automation

12. Column Packing
　Introduction
　Theory
　Preparation of Column System
　Packing the Column
　Evaluating Column Packing Quality
　Scale Up

Appendix