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Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling Features a variety of chromatographic case studies not readily accessible to the general public Represents an essential reference resource for academic, industrial, and pharmaceutical researchers
Auteur
ARNE STABY is a Fellow and Senior Principal Scientist at Novo Nordisk A/S, Denmark, and the author of numerous papers and presentations in the field.
ANURAG S. RATHORE is a Professor in the Department of Chemical Engineering at the Indian Institute of Technology, New Delhi, India. He has published several books that include Quality by Design for Biopharmaceuticals: Principles and Case Studies (Wiley, 2009). SATINDER AHUJA is President of Ahuja Consulting, USA, and the author/editor of numerous books including Chiral Separation Methods for Pharmaceutical and Biotechnological Products (Wiley, 2010), Trace and Ultratrace Analysis by HPLC (Wiley, 1992), and Selectivity and Detectability Optimizations in HPLC (Wiley, 1989).
Texte du rabat
Preparative chromatography is a key tool for biopharmaceutical purification for separation of proteins and peptides. Although theory and models have been available for several decades, industrial usage of these tools has been scarce. However, recently implemented quality-by-design (QbD) concepts have led to greater application of modeling in commercial process development and manufacture of proteins and peptides.
Written for those biotechnologists, biochemists, pharmaceutical scientists, and engineers working on this aspect of drug development, Preparative Chromatography for Separation of Proteins addresses a wide range of modeling techniques, strategies, and case studies of industrial separation of proteins and peptides. Chapters 1-7 cover basic modeling and reviews, with focus on chromatographic theory developments and research on the fundamentals of chromatographic separation and protein behavior. Chapters 8-18 relate to industrial separations, addressing trends in chromatographic unit operations and how mechanistic and empirical modeling approaches help optimize processes, as well as industrial case histories of various modeling approaches—like multivariate data analysis, design of experiment (DoE), and mechanistic modeling for design space establishment, on-column refolding, and so on. With its unique pairing of academic and industrial perspectives, this book is an indispensable resource for all those involved in the purification of biopharmaceuticals.
Résumé
Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides.
• Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives
• Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling
• Features a variety of chromatographic case studies not readily accessible to the general public
• Represents an essential reference resource for academic, industrial, and pharmaceutical researchers
Contenu
List of Contributors xv
Series Preface xix
Preface xxi
1 Model?-Based Preparative Chromatography Process Development in the QbD Paradigm 1
Arne Staby, Satinder Ahuja, and Anurag S. Rathore
1.1 Motivation 1
1.2 Regulatory Context of Preparative Chromatography and Process Understanding 1
1.3 Application of Mathematical Modeling to Preparative Chromatography 6
Acknowledgements 8
References 8
2 Adsorption Isotherms: Fundamentals and Modeling Aspects 11
Jørgen M. Mollerup
2.1 Introduction 11
2.2 Definitions 12
2.3 The Solute Velocity Model 14
2.4 Introduction to the Theory of Equilibrium 17
2.5 Association Equilibria 21
2.6 The Classical Adsorption Isotherm 24
2.7 The Classical Ion Exchange Adsorption Isotherm 26
2.8 Hydrophobic Adsorbents, HIC and RPC 38
2.9 ProteinProtein Association and Adsorption Isotherms 47
2.10 The Adsorption Isotherm of a GLP?-1 Analogue 51
2.11 Concluding Remarks 59
Appendix 2.A Classical Thermodynamics 60
References 77
3 Simulation of Process Chromatography 81
Bernt Nilsson and Niklas Andersson
3.1 Introduction 81
3.2 Simulation?-Based Prediction of Chromatographic Processes 82
3.3 Numerical Methods for Chromatography Simulation 94
3.4 Simulation?-Based Model Calibration and Parameter Estimation 96
3.5 Simulation?-Based Parametric Analysis of Chromatography 97
3.6 Simulation?-Based Optimization of Process Chromatography 101
3.7 Summary 106
Acknowledgement 107
References 108
4 Simplified Methods Based on Mechanistic Models for Understanding and Designing Chromatography Processes for Proteins and Other Biological Products 111
Noriko Yoshimoto and Shuichi Yamamoto
4.1 Introduction 111
4.2 HETP and Related Variables in Isocratic Elution 114
4.3 Linear Gradient Elution (LGE) 120
4.4 Applications of the Model 130
4.5 Summary 145
Appendix 4.A Mechanistic Models for Chromatography 149
Appendix 4.B Distribution Coefficient and Binding Sites [20- 149
References 152
5 Development of Continuous Capture Steps in Bioprocess Applications 159
Frank Riske and Tom Ransohoff
5.1 Introduction 159
5.2 Economic Rationale for Continuous Processing 160
5.3 Developing a Continuous Capture Step 162
5.4 The Operation of MCC Systems 165
5.5 Modeling MCC Operation 167
5.6 Processing Bioreactor Feeds on a Capture MCC 169
5.7 The Future of MCC 171
References 172
6 Computational Modeling in Bioprocess Development 177
Francis Insaidoo, Suvrajit Banerjee, David Roush, and Steven Cramer
6.1 Linkage of Chromatographic Thermodynamics (Affinity, Kinetics, and Capacity) 177
6.2 Binding Maps and Coarse?-Grained Modeling 180
6.3 QSPR for Either Classification or Quantification Prediction 188
6.4 All Atoms MD Simulations for Free Solution Studies and Surfaces 192
6.5 Ensemble Average and Comparison of Binding of Different Proteins in Chromatographic Systems 204
6.6 Antibody Homology Modeling and Bioprocess Development 205
6.7 Summary of Gaps and Future State 209
Acknowledgment 212
References 212
7 Chromatographic Scale?-Up on a Volume Basis 227
Ernst B. Hansen
7.1 Introduction 227
7.2 Theoretical Background 229
7.3 Proof of Concept Examples 232
7.4 Design Applications: How to Scale up from Development Data 233
7.5 Discussion 240
7.6 Recommendations 242
References 245
8 Scaling Up Industrial Protein Chromatography: Where Modeling Can Help 247
*Chris Antoni...