Preparative chromatography for separation of proteins / edited by Arne Staby, Anurag S. Rathore and Satinder Ahuja.

Format:

Book

Contributor:

Ahuja, Satinder, 1933- editor.

Rathore, Anurag S. (Anurag Singh), 1973- editor.

Staby, Arne, editor.

Series:

Wiley series in biotechnology and bioengineering.

Wiley Series in Biotechnology and Bioengineering

Language:

English

Subjects (All):

Chromatographic analysis.

Separation (Technology).

Physical Description:

1 online resource (710 pages).

Edition:

1st ed.

Place of Publication:

Hoboken, New Jersey : John Wiley & Sons, Inc., 2017.

Summary:

"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"-- Provided by publisher.

"Preparative Chromatography for Separation of Proteins addresses a wide range of the most current modeling techniques, strategies, and case studies of industrial separation of proteins and peptides to aid in the efficiency and efficacy of this broadly-used technique in the purification of biopharmaceuticals"-- Provided by publisher.

Contents:

Intro

Title Page

Table of Contents

List of Contributors

Series Preface

Preface

1 Model‐Based Preparative Chromatography Process Development in the QbD Paradigm

1.1 Motivation

1.2 Regulatory Context of Preparative Chromatography and Process Understanding

1.3 Application of Mathematical Modeling to Preparative Chromatography

Acknowledgements

References

2 Adsorption Isotherms

2.1 Introduction

2.2 Definitions

2.3 The Solute Velocity Model

2.4 Introduction to the Theory of Equilibrium

2.5 Association Equilibria

2.6 The Classical Adsorption Isotherm

2.7 The Classical Ion Exchange Adsorption Isotherm

2.8 Hydrophobic Adsorbents, HIC and RPC

2.9 Protein-Protein Association and Adsorption Isotherms

2.10 The Adsorption Isotherm of a GLP‐1 Analogue

2.11 Concluding Remarks

Appendix 2.A Classical Thermodynamics

3 Simulation of Process Chromatography

3.1 Introduction

3.2 Simulation‐Based Prediction of Chromatographic Processes

3.3 Numerical Methods for Chromatography Simulation

3.4 Simulation‐Based Model Calibration and Parameter Estimation

3.5 Simulation‐Based Parametric Analysis of Chromatography

3.6 Simulation‐Based Optimization of Process Chromatography

3.7 Summary

Acknowledgement

4 Simplified Methods Based on Mechanistic Models for Understanding and Designing Chromatography Processes for Proteins and Other Biological Products‐Yamamoto Models and Yamamoto Approach

4.1 Introduction

4.2 HETP and Related Variables in Isocratic Elution

4.3 Linear Gradient Elution (LGE)

4.4 Applications of the Model

4.5 Summary

Appendix 4.A Mechanistic Models for Chromatography

Appendix 4.B Distribution Coefficient and Binding Sites [20]

5 Development of Continuous Capture Steps in Bioprocess Applications.

5.1 Introduction

5.2 Economic Rationale for Continuous Processing

5.3 Developing a Continuous Capture Step

5.4 The Operation of MCC Systems

5.5 Modeling MCC Operation

5.6 Processing Bioreactor Feeds on a Capture MCC

5.7 The Future of MCC

6 Computational Modeling in Bioprocess Development

6.1 Linkage of Chromatographic Thermodynamics (Affinity, Kinetics, and Capacity)

6.2 Binding Maps and Coarse‐Grained Modeling

6.3 QSPR for Either Classification or Quantification Prediction

6.4 All Atoms MD Simulations for Free Solution Studies and Surfaces

6.5 Ensemble Average and Comparison of Binding of Different Proteins in Chromatographic Systems

6.6 Antibody Homology Modeling and Bioprocess Development

6.7 Summary of Gaps and Future State

Acknowledgment

7 Chromatographic Scale‐Up on a Volume Basis

7.1 Introduction

7.2 Theoretical Background

7.3 Proof of Concept Examples

7.4 Design Applications: How to Scale up from Development Data

7.5 Discussion

7.6 Recommendations

8 Scaling Up Industrial Protein Chromatography

8.1 Introduction

8.2 Packing Quality: Why and How to Ensure Column Packing Quality Across Scales

8.3 Process Equipment: Using CFD to Describe Effects of Equipment Design on Column Performance

8.4 Long‐Term Column Operation at Scale: Impact of Resin Lot‐to‐Lot Variability

8.5 Closing Remarks

9 High‐Throughput Process Development

9.1 Introduction to High‐Throughput Process Development in Chromatography

9.2 Process Development Approaches

9.3 Case Descriptions

9.4 Future Directions

10 High‐Throughput Column Chromatography Performed on Liquid Handling Stations

10.1 Introduction

10.2 Chromatographic Methods

10.3 Results and Discussion

10.4 Summary and Conclusion.

Acknowledgements

11 Lab‐Scale Development of Chromatography Processes

11.1 Introduction

11.2 Methodology and Proposed Workflow

11.3 Conclusions

Acknowledgments

12 Problem Solving by Using Modeling

12.1 Introduction

12.2 Theory

12.3 Materials and Methods

12.4 Determination of Model Parameters

12.5 Optimization In Silico

12.6 Extra‐Column Effects

Abbreviations

13 Modeling Preparative Cation Exchange Chromatography of Monoclonal Antibodies

13.1 Introduction

13.2 Theory

13.3 Model Development

13.4 Model Application

13.5 Conclusions

13.6 Acknowledgments

14 Model‐Based Process Development in the Biopharmaceutical Industry

14.1 Introduction

14.2 Molecule-FVIII

14.3 Overall Process Design

14.4 Use of Mathematical Models to Ensure Process Robustness

14.5 Experimental Design of Verification Experiments

14.6 Discussion

14.7 Conclusion

Appendix 14.A Practical MATLAB Guideline to SEC

Appendix 14.B Derivation of Models Used for Column Simulations

15 Dynamic Simulations as a Predictive Model for a Multicolumn Chromatography Separation

15.1 Introduction

15.2 BioSMB Technology

15.3 Protein A Model Description

15.4 Fitting the Model Parameters

15.5 Case Studies

15.6 Results for Continuous Chromatography

15.7 Conclusions

16 Chemometrics Applications in Process Chromatography

16.1 Introduction

16.2 Data Types

16.3 Data Preprocessing

16.4 Modeling Approaches

16.5 Case Studies of Use of Chemometrics in Process Chromatography

16.6 Guidance on Performing MVDA

17 Mid‐UV Protein Absorption Spectra and Partial Least Squares Regression as Screening and PAT Tool

17.1 Introduction.

17.2 Mid‐UV Protein Absorption Spectra and Partial Least Squares Regression

17.3 Spectral Similarity and Prediction Precision

17.4 Application as a Screening Tool: Analytics for High‐Throughput Experiments

17.5 Application as a PAT Tool: Selective In‐line Quantification and Real‐Time Pooling

17.6 Case Studies

17.7 Conclusion and Outlook

18 Recent Progress Toward More Sustainable Biomanufacturing

18.1 Introduction

18.2 The Impact of Individualized Unit Operations versus Integrated Platform Technologies on Sustainable Manufacturing

18.3 Implications of Recycling and Reuse in Downstream Processing of Protein Products Generated by Biotechnological Processes: General Considerations

18.4 Metrics and Valorization Methods to Assess Process Sustainability

18.5 Conclusions and Perspectives

Index

End User License Agreement.

Notes:

Includes bibliographical references and index.

Description based on print version record.

ISBN:

9781119031178

1119031176

9781119031154

111903115X

9781119031116

1119031117

OCLC:

971542319