Bioseparations of Proteins: Unfolding/Folding and Validations
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Table of contents
- Cover
- CONTENTSv
- PREFACEix
- LIST OF EXAMPLESxiii
- Chapter I. Introduction1
- I. Introduction1
- II. The Need for Bioseparation1
- III. Classification of Bioseparation Steps2
- IV. Upstream and Downstream Processing4
- V. Some Factors Influencing Bioseparation8
- References15
- Chapter 2. Steps in Bioseparation Processes19
- I. Introduction19
- II. Product Excretion from the Cell or Cell Disruption24
- III. Initial Fractionation30
- IV. High-Resolution Fractionation50
- V. Conclusions55
- References56
- Chapter 3. High-Resolution Fractionation Processes61
- I. Introduction61
- II. Chromatographic Procedures62
- III. Crystallization85
- IV. Other Techniques91
- V. Conclusions96
- References97
- Chapter 4. Interfaciai Protein Adsorption and Inactivation during Bioseparation101
- I. Introduction101
- II. Reaction and Inactivation at Liquid-Liquid Interfaces104
- III. Reaction and Inactivation at Gas-Liquid Interfaces109
- IV. Reaction and Inactivation at Liquid-SoUd Interfaces118
- V. Conclusions130
- References131
- Chapter 5. Protein Inactivations during Chromatographic Methods of Separation135
- I. Introduction135
- II. Chromatographic Techniques137
- III. Conclusions172
- References173
- Chapter 6. Protein Inactivations during Novel Bioseparation Techniques177
- I. Introduction177
- II. Liquid-Liquid Extraction179
- III. Conclusions208
- References208
- Chapter 7. Adsorption Influence on Bioseparation and Inactivation213
- I. Introduction213
- II. Adsorption of Proteins and Other Biological Macromolecules217
- III. Heterogeneity in Protein Adsorption228
- IV. Techniques for Qualitative Characterization of Protein Adsorption236
- V. Models for Protein Adsorption on Surfaces246
- VI. Conclusions254
- References255
- Chapter 8. Applications and Economics of Bioseparation259
- I. Introduction259
- II. Scale-Up Procedures265
- III. Economics of Bioseparation272
- IV. Conclusions282
- References283
- Chapter 9. Protein Refolding and Inactivation during Bioseparation287
- I. Introduction287
- II. Different Purification Protocols for Recovering Proteins in the Denatured State289
- III. In Vitro Folding Mechanisms of Proteins291
- IV. Conclusions309
- References309
- Chapter 10. Validation of the Production of Biological Products313
- I. Introduction313
- II. Validation of rDNA Processes317
- III. Validation of Column-Based Separation Processes320
- IV. Validation of Analytic Methods for Pharmaceutical Product Development322
- V. Process Validation of Bulk Biopharmaceuticals324
- VI. Validation of the Preparation of Clinical Monoclonal Antibodies325
- VII. Validation Studies for the Regeneration of Ion-Exchange Cellulose Columns328
- VIII. Cleaning Validation and Residue Limits331
- IX. Conclusions336
- References337
- INDEX339
This book covers the fundamentals of protein inactivation during bioseparation and the effect on protein processing. Bioseparation of Proteins is unique because it provides a background of the bioseparation processes, and it is the first book available to emphasize the influence of the different bioseparation processes on protein inactivation.
Bioseparation of Proteins covers the extent, mechanisms of, and control of protein inactivation during these processes along with the subsequent and essential validation of these processes. The book focuses on the avoidance of protein (biologicalproduct) inactivation at each step in a bioprocess. It compares protein inactivation exhibited during the different bioseparation processes by different workers and provides a valuable framework for workers in different areas interested in bioseparations.
Topics include separation and detection methods; estimates of protein inactivation and an analysis of this problem for different separation processes; strategies for avoiding inactivation; the molecular basis of surface activity and protein adsorption,process monitoring, and product validation techniques; and the economics of various bioseparation processes and quality control procedures.
Key Features
* Protein inactivation and other aspects of biological stability are critical to an effective bioseparation process; This book is a detailed and critical review of the available literature in an area that is essential to the effectiveness, validation, and economics of bioseparation processes for drugs and other biological products; Conveniently assembled under one cover, the survey of the literature and resulting perspective will greatly assist engineers and chemists in designingand improving their own processes; Key features of the text include:
* detailed data on biological stability under various bioseparation conditions
* extensive case studies from the literature on separation processes, validation, and economics
* simplified analysis of protein refolding and inactivation mechanisms
* consideration of adsorption theories and the effect of heterogeneity
* coverage of both classical and novel bioseparation techniques, including chromatographic procedures
Bioseparation of Proteins covers the extent, mechanisms of, and control of protein inactivation during these processes along with the subsequent and essential validation of these processes. The book focuses on the avoidance of protein (biologicalproduct) inactivation at each step in a bioprocess. It compares protein inactivation exhibited during the different bioseparation processes by different workers and provides a valuable framework for workers in different areas interested in bioseparations.
Topics include separation and detection methods; estimates of protein inactivation and an analysis of this problem for different separation processes; strategies for avoiding inactivation; the molecular basis of surface activity and protein adsorption,process monitoring, and product validation techniques; and the economics of various bioseparation processes and quality control procedures.
Key Features
* Protein inactivation and other aspects of biological stability are critical to an effective bioseparation process; This book is a detailed and critical review of the available literature in an area that is essential to the effectiveness, validation, and economics of bioseparation processes for drugs and other biological products; Conveniently assembled under one cover, the survey of the literature and resulting perspective will greatly assist engineers and chemists in designingand improving their own processes; Key features of the text include:
* detailed data on biological stability under various bioseparation conditions
* extensive case studies from the literature on separation processes, validation, and economics
* simplified analysis of protein refolding and inactivation mechanisms
* consideration of adsorption theories and the effect of heterogeneity
* coverage of both classical and novel bioseparation techniques, including chromatographic procedures