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El. knyga: Continuous Biopharmaceutical Processes: Chromatography, Bioconjugation, and Protein Stability

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, (Massachusetts Institute of Technology), (Eidgenössische Technische Hochschule Zürich)
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Continuous Biopharmaceutical Processes: Chromatography, Bioconjugation, and Protein StabilityDidesnis paveikslėlis
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Provides a coherent and critical view on the potential benefits of various continuous processes in the biopharmaceutical industry.

This innovative reference provides a coherent and critical view on the potential benefits of a transition from batch to continuous processes in the biopharmaceutical industry, with the main focus on chromatography. It also covers the key topics of protein stability and protein conjugation, addressing the chemical reaction and purification aspects together with their integration. This book offers a fine balance between theoretical modelling and illustrative case studies, between fundamental concepts and applied examples from the academic and industrial literature. Scientists interested in the design of biopharmaceutical processes will find useful practical methodologies, in particular for single-column and multi-column chromatographic processes.

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Provides a coherent and critical view on the potential benefits of various continuous processes in the biopharmaceutical industry.
Preface ix
Notation xi
1 Introduction to Biopharmaceutical Processes 1(26)
1.1 Context
1(1)
1.2 Single-Unit Operations
1(6)
1.2.1 Cell Culture
2(1)
1.2.2 Primary Recovery
3(1)
1.2.3 Protein Capture
4(1)
1.2.4 Polishing Steps
5(1)
1.2.5 Viral Clearance
5(1)
1.2.6 Formulation
6(1)
1.2.7 Additional steps
6(1)
1.3 Overview of the Impurities to Be Removed
7(2)
1.3.1 Process-Related and Product-Related Impurities
7(1)
1.3.2 Purity Specifications
8(1)
1.4 Continuous Production Processes
9(18)
1.4.1 Definition of Batch and Continuous Processes
10(2)
1.4.2 Industrial Context
12(1)
1.4.3 Some Engineering Considerations
13(14)
2 Fundamentals of Protein Chromatography 27(57)
2.1 Introduction
27(1)
2.2 Interactions with Chromatographic Media
27(6)
2.2.1 Steric Interactions
27(1)
2.2.2 Hydrophobic Interactions
28(1)
2.2.3 Electrostatic Interactions
29(1)
2.2.4 Biospecific Interactions
30(1)
2.2.5 Complexation
31(1)
2.2.6 Multimodal Interactions
32(1)
2.3 Modes of Operation
33(2)
2.3.1 Single-Column Systems
33(2)
2.3.2 Multicolumn Systems
35(1)
2.4 Mechanistic Models
35(32)
2.4.1 Overview
36(3)
2.4.2 Thermodynamics of Fluid-Solid Equilibrium
39(12)
2.4.3 Hydrodynamics
51(4)
2.4.4 Kinetics of Mass Transfer
55(7)
2.4.5 Column Efficiency
62(5)
2.5 Model Parameter Estimation
67(11)
2.5.1 Generalities
67(1)
2.5.2 Thermodynamics of Fluid-Solid Equilibrium
68(5)
2.5.3 Hydrodynamics
73(1)
2.5.4 Kinetics of Mass Transfer
74(1)
2.5.5 Case Study
74(4)
2.6 Process Design
78(5)
2.6.1 Process Performance Criteria
78(1)
2.6.2 Process Optimization
79(1)
2.6.3 Shortcut Design
80(3)
2.7 Conclusion
83(1)
3 Countercurrrent Separation Processes 84(26)
3.1 Introduction
84(1)
3.2 Countercurrent Separation for Idealized Systems
84(9)
3.2.1 The Equilibrium Stage
84(3)
3.2.2 Cascade of Equilibrium Stages
87(1)
3.2.3 Two-Zone Countercurrent Separation Unit
88(3)
3.2.4 Four-Zone Countercurrent Separation Unit
91(2)
3.3 The Simulated Moving Bed Process
93(2)
3.3.1 Principle
93(2)
3.3.2 Dynamic Behavior
95(1)
3.4 Separation Region for More Realistic Systems
95(6)
3.4.1 Impact of Nonlinearities in the Fluid-Solid Equilibria
97(2)
3.4.2 Impact of Dispersive Phenomena
99(2)
3.5 Design of Countercurrent Chromatographic Processes
101(7)
3.5.1 Unified Design Approach
101(3)
3.5.2 Empirical Design of a Multicolumn Process from a Single-Column Chromatogram
104(1)
3.5.3 Shortcut Design of Countercurrent Chromatographic Processes
105(1)
3.5.4 Benefits from Countercurrent Chromatographic Processes
106(2)
3.6 Conclusion
108(2)
4 Countercurrent Chromatography for the Capture Step 110(43)
4.1 Introduction
110(1)
4.2 Process Operations and Associated Physical Phenomena
111(14)
4.2.1 Typical Sequence of Process Operations
111(1)
4.2.2 Thermodynamics of Fluid-Solid Equilibrium
112(4)
4.2.3 Hydrodynamics and Kinetics of Mass Transfer
116(9)
4.3 Design of Countercurrent Chromatographic Processes
125(27)
4.3.1 Principle
125(2)
4.3.2 Definition of the Process Variables
127(1)
4.3.3 Processes with a Number of Columns per Zone Constant during One Cycle
128(13)
4.3.4 Processes with a Number of Columns per Zone Changing during One Cycle
141(5)
4.3.5 Process Optimization
146(3)
4.3.6 Process Control
149(3)
4.4 Conclusion
152(1)
5 Countercurrent Chromatography for the Polishing Steps 153(50)
5.1 Introduction
153(1)
5.2 Process Operations and Associated Physical Phenomena
153(14)
5.2.1 Chromatographic Modes
153(3)
5.2.2 Thermodynamics of the Fluid-Solid Equilibrium
156(5)
5.2.3 Hydrodynamics and Kinetics of Mass Transfer
161(6)
5.3 Design of Countercurrent Chromatographic Processes
167(34)
5.3.1 Binary Separations
167(12)
5.3.2 Ternary Separations
179(21)
5.3.3 Process Control
200(1)
5.4 Conclusion
201(2)
6 Protein Conjugation 203(44)
6.1 Introduction
203(1)
6.2 The Conjugation Reaction
204(21)
6.2.1 Conjugation Chemistry
204(2)
6.2.2 Kinetics of the Conjugation Reaction
206(10)
6.2.3 Conjugation Reactors
216(9)
6.3 Purification of Conjugated Proteins
225(13)
6.3.1 Separation Challenges
225(1)
6.3.2 Filtration
226(2)
6.3.3 Chromatography
228(10)
6.4 Process Integration
238(7)
6.4.1 Motivations
238(1)
6.4.2 Protein Recycling and Overall Conversion
239(2)
6.4.3 Process Performances: Yield and Productivity
241(3)
6.4.4 Batch or Continuous Operation?
244(1)
6.5 Conclusion
245(2)
7 Protein Aggregation in Biopharmaceutical Processes 247(52)
7.1 Introduction
247(1)
7.2 Experimental Characterization of Protein Solutions
248(9)
7.2.1 Aggregate Content, Size, and Morphology
248(3)
7.2.2 Protein-Protein Interactions
251(3)
7.2.3 Protein Structure
254(2)
7.2.4 Solution Viscosity
256(1)
7.2.5 Summary
257(1)
7.3 Protein Aggregation Mechanisms
257(12)
7.3.1 Colloidal Stability and Conformational Stability
257(5)
7.3.2 Aggregation Pathway
262(2)
7.3.3 Aggregation Rate Constants
264(2)
7.3.4 Population Balance Equations
266(3)
7.4 Impact of Operating Conditions on Protein Aggregation
269(9)
7.4.1 Solution pH
269(2)
7.4.2 Salt Type and Concentration
271(3)
7.4.3 Temperature
274(1)
7.4.4 Protein Concentration
275(3)
7.5 Critical Steps for Aggregation in Biopharmaceutical Processes
278(9)
7.5.1 Upstream
278(1)
7.5.2 Capture Step
279(1)
7.5.3 Polishing Steps
279(4)
7.5.4 Viral Inactivation
283(1)
7.5.5 Filtration
284(3)
7.5.6 Summary
287(1)
7.6 Methods to Reduce the Aggregate Content
287(9)
7.6.1 Limiting Aggregate Formation
287(5)
7.6.2 Removing Aggregates
292(4)
7.7 Conclusion
296(3)
8 Conclusion 299(2)
Bibliography 301(25)
Index 326
David Pfister is project manager at Ypso Facto (Nancy, France), where he is developing the software ChromWorks, which has been used to perform the large majority of the simulations of chromatographic processes shown in this book. He was a doctorate student of Professor Morbidelli at Eidgenössische Technische Hochschule Zürich (ETH Zurich) and graduated in 2015. His Ph.D. thesis focused on protein conjugation, and his research also dealt with the fundamental understanding of protein chromatography. Before joining ETH Zurich, he obtained a master degree in chemical engineering from École Nationale Supérieure des Industries Chimiques (Nancy, France). Lucrčce Nicoud is the recipient of a fellowship from the Swiss National Foundation financing her current research on the crystallization of pharmaceutical ingredients at the Massachusetts Institute of Technology. She was a doctorate student of Professor Morbidelli at Eidgenössische Technische Hochschule Zürich (ETH Zurich) and graduated in 2015. Her Ph.D. focused on protein aggregation, and her research also dealt with the fundamental understanding of protein chromatography. Before joining ETH Zurich, she obtained a master degree in chemical engineering from École Nationale Supérieure des Industries Chimiques (Nancy, France). Massimo Morbidelli is Professor at Eidgenössische Technische Hochschule Zürich (ETH Zurich) since 1996 and at Politecnico di Milano (Italy) since 1991. His research focuses on the production, purification, conjugation and aggregation of therapeutic proteins. Other research activities carried out in his group deal with polymer and colloid science. Professor Morbidelli received the Excellence in Process Development Research Award from the American Institute of Chemical Engineers in 2017 and the Separation Science and Technology Award from the American Chemical Society in 2018 for his work on the continuous production and purification of monoclonal antibodies.
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