Handbook of Process Chromatography: Development, Manufacturing, Validation and Economics
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Table of contents
- Contentsv
- Prefacexv
- Acknowledgementsxvii
- Chapter 1. Biopharmaceuticals Today1
- 1.1 Industrial Context1
- 1.2 Overview of Biopharmaceutical History2
- 1.3 Biopharma Business Environment6
- 1.4 Key Business Issues10
- 1.5 Process Chromatography Within an Industrial Context16
- 1.6 Summary20
- References21
- Chapter 2. Process Capability and Production Scenarios23
- 2.1 Process Capability23
- 2.2 Production Setups27
- 2.3 Process Capability Conclusions37
- References39
- Chapter 3. Process-Design Concepts41
- 3.1 Typical Process Design for Biopharmaceuticals41
- 3.2 Management Framework for Process Design43
- 3.3 Production Cells and Typical Product Characteristics47
- 3.4 Risk Analysis and Risk Mitigation55
- 3.5 Downstream Processing60
- 3.6 Selected Downstream Processing Platform Examples69
- 3.7 Characterizing the Process, Process Understanding73
- References78
- Chapter 4. Separation Technologies81
- 4.1 Introduction81
- 4.2 Recovery81
- 4.3 Purification86
- 4.4 Equipment121
- 4.5 Selecting Tools from R&D to Production122
- References122
- Chapter 5. Analysis127
- 5.1 Introduction127
- 5.2 Proteins127
- 5.3 Nucleic Acid Products136
- 5.4 Comparability140
- 5.5 Setting Specifications and Reference Standards140
- 5.6 Method Validation141
- 5.7 Process Analytical Technologies (PAT)141
- References142
- Chapter 6. Cleaning and Sanitization147
- 6.1 Introduction147
- 6.2 Cleaning147
- 6.3 Decontamination of Transmissible Spongiform Encephalopathy Agents153
- 6.4 Sanitization154
- References158
- Chapter 7. Validation161
- 7.1 Introduction161
- 7.2 What to do When?162
- 7.3 Validation of Downstream Processes164
- 7.4 Making Changes184
- 7.5 Summary185
- Acknowledgements185
- References186
- Chapter 8. Economics189
- 8.1 Economics: An Educational Excursion190
- 8.2 LEAN Manufacturing, Removal of Unproductive Activities197
- 8.3 Cost Model: Monoclonal Antibody Downstream Process199
- 8.4 Cost Improvement Options202
- 8.5 Impact from R&D, Platform Strategies and Technology Outlook214
- 8.6 Conclusions, the Improvement Hierarchy215
- References216
- Chapter 9. Basic Properties of Peptides, Proteins, Nucleic Acids and Virus Particles219
- 9.1 Introduction219
- 9.2 Peptides219
- 9.3 Proteins222
- 9.4 Nucleic Acids228
- 9.5 Viruses231
- References234
- Chapter 10. Optimization of Chromatographic Separations237
- 10.1 Introduction237
- 10.2 Basic Relationships238
- 10.3 Purification Principles245
- 10.4 Adsorption267
- 10.5 Elution Modes272
- 10.6 Bed Configuration274
- 10.7 Experimental Determination of Basic Parameters276
- 10.8 Modelling of Chromatographic Purifications284
- 10.9 Simulation of Separations291
- References292
- Chapter 11. Equipment299
- 11.1 Guidelines for Selecting Pilot Plant and Production Chromatography Equipment299
- 11.2 Selection of Components306
- 11.3. Automation314
- References319
- Chapter 12. Column Packing321
- 12.1 Introduction321
- 12.2 Theory321
- 12.3 Preparation of Column and System323
- 12.4 Packing the Column324
- 12.5 Evaluating Column Packing Quality326
- 12.6 Scale up329
- References330
- Appendix A: Symbols and Definitions in Liquid Chromatography331
- A.1 Introduction331
- A.2 Symbols Used in Liquid Chromatography331
- A.3 Definitions of Chromatographic Parameters and Equations333
- References336
- Appendix B: Dimensionless Numbers337
- B.1 Introduction337
- References339
- Appendix C: Activities for Biopharmaceutical Production from Genetically Engineered Mammalian Cells341
- C.1 Introduction341
- C.2 Activities Chart from Toxicology to License Application341
- Appendix D: Simulations Using the Supplied Software345
- D.1 Introduction345
- D.2 How to Use the Software?345
- D.3 Pressure Drop346
- D.4 Sample Volume347
- D.5 Resolution in SEC348
- D.6 Resolution in IEC, RPC and HIC348
- D.7 Isocratic Separation349
- D.8 Yield and Purity350
- D.9 Langmuir Isotherm350
- D.10 About this Software351
- Subject Index353
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
- illustrations and tables
- automated column packing
- automated systems
New topics include:
- the use of disposables
- multiproduct versus dedicated production
- design principles for chromatography media and filters
- ultrafiltration principles and optimization
- risk assessments
- characterization studies
- design space
- platform technologies
- process analytical technologies (PATs)
- biogenerics
- comparability assessments
Key Features:
- new approaches to process optimiaztion
- use of patform technologies
- applying risk assessment to process design
Updates include:
- sources and productivity
- types of products made today
- experiences in clinical and licensed products
- economics
- current status of validation
- illustrations and tables
- automated column packing
- automated systems
New topics include:
- the use of disposables
- multiproduct versus dedicated production
- design principles for chromatography media and filters
- ultrafiltration principles and optimization
- risk assessments
- characterization studies
- design space
- platform technologies
- process analytical technologies (PATs)
- biogenerics
- comparability assessments
Key Features:
- new approaches to process optimiaztion
- use of patform technologies
- applying risk assessment to process design