UID:
almafu_9958079536602883
Umfang:
1 online resource (383 p.)
Ausgabe:
2nd ed. / Lars Hagel, Gu nter Jagschies and Gail Sofer.
ISBN:
1-281-07684-8
,
9786611076849
,
0-08-055451-2
Inhalt:
This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity- types of products made today- experiences in clinical and licensed products - economics- current status of validation- illu
Anmerkung:
Previous ed.: published as by G.K. Sofer and Lars Hagel. 1997.
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Front cover; Handbook of Process Chromatography; Copyright page; Contents; Preface; Acknowledgements; Chapter 1. Biopharmaceuticals Today; 1.1 Industrial Context; 1.2 Overview of Biopharmaceutical History; 1.3 Biopharma Business Environment; 1.4 Key Business Issues; 1.5 Process Chromatography Within an Industrial Context; 1.6 Summary; References; Chapter 2. Process Capability and Production Scenarios; 2.1 Process Capability; 2.2 Production Setups; 2.3 Process Capability Conclusions; References; Chapter 3. Process-Design Concepts; 3.1 Typical Process Design for Biopharmaceuticals
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3.2 Management Framework for Process Design3.3 Production Cells and Typical Product Characteristics; 3.4 Risk Analysis and Risk Mitigation; 3.5 Downstream Processing; 3.6 Selected Downstream Processing Platform Examples; 3.7 Characterizing the Process, Process Understanding; References; Chapter 4. Separation Technologies; 4.1 Introduction; 4.2 Recovery; 4.3 Purification; 4.4 Equipment; 4.5 Selecting Tools from R&D to Production; References; Chapter 5. Analysis; 5.1 Introduction; 5.2 Proteins; 5.3 Nucleic Acid Products; 5.4 Comparability; 5.5 Setting Specifications and Reference Standards
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5.6 Method Validation5.7 Process Analytical Technologies (PAT); References; Chapter 6. Cleaning and Sanitization; 6.1 Introduction; 6.2 Cleaning; 6.3 Decontamination of Transmissible Spongiform Encephalopathy Agents; 6.4 Sanitization; References; Chapter 7. Validation; 7.1 Introduction; 7.2 What to do When?; 7.3 Validation of Downstream Processes; 7.4 Making Changes; 7.5 Summary; Acknowledgements; References; Chapter 8. Economics; 8.1 Economics: An Educational Excursion; 8.2 LEAN Manufacturing, Removal of Unproductive Activities; 8.3 Cost Model: Monoclonal Antibody Downstream Process
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8.4 Cost Improvement Options8.5 Impact from R&D, Platform Strategies and Technology Outlook; 8.6 Conclusions, the Improvement Hierarchy; References; Chapter 9. Basic Properties of Peptides, Proteins, Nucleic Acids and Virus Particles; 9.1 Introduction; 9.2 Peptides; 9.3 Proteins; 9.4 Nucleic Acids; 9.5 Viruses; References; Chapter 10. Optimization of Chromatographic Separations; 10.1 Introduction; 10.2 Basic Relationships; 10.3 Purification Principles; 10.4 Adsorption; 10.5 Elution Modes; 10.6 Bed Configuration; 10.7 Experimental Determination of Basic Parameters
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10.8 Modelling of Chromatographic Purifications10.9 Simulation of Separations; References; Chapter 11. Equipment; 11.1 Guidelines for Selecting Pilot Plant and Production Chromatography Equipment; 11.2 Selection of Components; 11.3. Automation; References; Chapter 12. Column Packing; 12.1 Introduction; 12.2 Theory; 12.3 Preparation of Column and System; 12.4 Packing the Column; 12.5 Evaluating Column Packing Quality; 12.6 Scale up; References; Appendix A: Symbols and Definitions in Liquid Chromatography; A.1 Introduction; A.2 Symbols Used in Liquid Chromatography
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A.3 Definitions of Chromatographic Parameters and Equations
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English
Weitere Ausg.:
ISBN 0-12-374023-1
Sprache:
Englisch
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