{"product_id":"preparative-chromatography-for-separation-of-proteins-isbn-9781119031109","title":"Preparative Chromatography for Separation of Proteins","description":"\u003ci\u003ePreparative Chromatography for Separation of Proteins\u003c\/i\u003e addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides.\u003cbr\u003e\u003cbr\u003e•    Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives\u003cbr\u003e•    Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling\u003cbr\u003e•    Features a variety of chromatographic case studies not readily accessible to the general public\u003cbr\u003e•    Represents an essential reference resource for academic, industrial, and pharmaceutical researchers \u003cp\u003eList of Contributors xv\u003c\/p\u003e \u003cp\u003eSeries Preface xix\u003c\/p\u003e \u003cp\u003ePreface xxi\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Model-Based Preparative Chromatography Process Development in the QbD Paradigm 1\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eArne Staby, Satinder Ahuja, and Anurag S. Rathore\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Motivation 1\u003c\/p\u003e \u003cp\u003e1.2 Regulatory Context of Preparative Chromatography and Process Understanding 1\u003c\/p\u003e \u003cp\u003e1.3 Application of Mathematical Modeling to Preparative Chromatography 6\u003c\/p\u003e \u003cp\u003eAcknowledgements 8\u003c\/p\u003e \u003cp\u003eReferences 8\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Adsorption Isotherms: Fundamentals and Modeling Aspects 11\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eJørgen M. Mollerup\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 11\u003c\/p\u003e \u003cp\u003e2.2 Definitions 12\u003c\/p\u003e \u003cp\u003e2.3 The Solute Velocity Model 14\u003c\/p\u003e \u003cp\u003e2.4 Introduction to the Theory of Equilibrium 17\u003c\/p\u003e \u003cp\u003e2.5 Association Equilibria 21\u003c\/p\u003e \u003cp\u003e2.6 The Classical Adsorption Isotherm 24\u003c\/p\u003e \u003cp\u003e2.7 The Classical Ion Exchange Adsorption Isotherm 26\u003c\/p\u003e \u003cp\u003e2.8 Hydrophobic Adsorbents, HIC and RPC 38\u003c\/p\u003e \u003cp\u003e2.9 Protein–Protein Association and Adsorption Isotherms 47\u003c\/p\u003e \u003cp\u003e2.10 The Adsorption Isotherm of a GLP-1 Analogue 51\u003c\/p\u003e \u003cp\u003e2.11 Concluding Remarks 59\u003c\/p\u003e \u003cp\u003eAppendix 2.A Classical Thermodynamics 60\u003c\/p\u003e \u003cp\u003eReferences 77\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Simulation of Process Chromatography 81\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eBernt Nilsson and Niklas Andersson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 81\u003c\/p\u003e \u003cp\u003e3.2 Simulation-Based Prediction of Chromatographic Processes 82\u003c\/p\u003e \u003cp\u003e3.3 Numerical Methods for Chromatography Simulation 94\u003c\/p\u003e \u003cp\u003e3.4 Simulation-Based Model Calibration and Parameter Estimation 96\u003c\/p\u003e \u003cp\u003e3.5 Simulation-Based Parametric Analysis of Chromatography 97\u003c\/p\u003e \u003cp\u003e3.6 Simulation-Based Optimization of Process Chromatography 101\u003c\/p\u003e \u003cp\u003e3.7 Summary 106\u003c\/p\u003e \u003cp\u003eAcknowledgement 107\u003c\/p\u003e \u003cp\u003eReferences 108\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Simplified Methods Based on Mechanistic Models for Understanding and Designing Chromatography Processes for Proteins and Other Biological Products 111\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eNoriko Yoshimoto and Shuichi Yamamoto\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 111\u003c\/p\u003e \u003cp\u003e4.2 HETP and Related Variables in Isocratic Elution 114\u003c\/p\u003e \u003cp\u003e4.3 Linear Gradient Elution (LGE) 120\u003c\/p\u003e \u003cp\u003e4.4 Applications of the Model 130\u003c\/p\u003e \u003cp\u003e4.5 Summary 145\u003c\/p\u003e \u003cp\u003eAppendix 4.A Mechanistic Models for Chromatography 149\u003c\/p\u003e \u003cp\u003eAppendix 4.B Distribution Coefficient and Binding Sites [20- 149\u003c\/p\u003e \u003cp\u003eReferences 152\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Development of Continuous Capture Steps in Bioprocess Applications 159\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eFrank Riske and Tom Ransohoff\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 159\u003c\/p\u003e \u003cp\u003e5.2 Economic Rationale for Continuous Processing 160\u003c\/p\u003e \u003cp\u003e5.3 Developing a Continuous Capture Step 162\u003c\/p\u003e \u003cp\u003e5.4 The Operation of MCC Systems 165\u003c\/p\u003e \u003cp\u003e5.5 Modeling MCC Operation 167\u003c\/p\u003e \u003cp\u003e5.6 Processing Bioreactor Feeds on a Capture MCC 169\u003c\/p\u003e \u003cp\u003e5.7 The Future of MCC 171\u003c\/p\u003e \u003cp\u003eReferences 172\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Computational Modeling in Bioprocess Development 177\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eFrancis Insaidoo, Suvrajit Banerjee, David Roush, and Steven Cramer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Linkage of Chromatographic Thermodynamics (Affinity, Kinetics, and Capacity) 177\u003c\/p\u003e \u003cp\u003e6.2 Binding Maps and Coarse-Grained Modeling 180\u003c\/p\u003e \u003cp\u003e6.3 QSPR for Either Classification or Quantification Prediction 188\u003c\/p\u003e \u003cp\u003e6.4 All Atoms MD Simulations for Free Solution Studies and Surfaces 192\u003c\/p\u003e \u003cp\u003e6.5 Ensemble Average and Comparison of Binding of Different Proteins in Chromatographic Systems 204\u003c\/p\u003e \u003cp\u003e6.6 Antibody Homology Modeling and Bioprocess Development 205\u003c\/p\u003e \u003cp\u003e6.7 Summary of Gaps and Future State 209\u003c\/p\u003e \u003cp\u003eAcknowledgment 212\u003c\/p\u003e \u003cp\u003eReferences 212\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Chromatographic Scale-Up on a Volume Basis 227\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eErnst B. Hansen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 227\u003c\/p\u003e \u003cp\u003e7.2 Theoretical Background 229\u003c\/p\u003e \u003cp\u003e7.3 Proof of Concept Examples 232\u003c\/p\u003e \u003cp\u003e7.4 Design Applications: How to Scale up from Development Data 233\u003c\/p\u003e \u003cp\u003e7.5 Discussion 240\u003c\/p\u003e \u003cp\u003e7.6 Recommendations 242\u003c\/p\u003e \u003cp\u003eReferences 245\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Scaling Up Industrial Protein Chromatography: Where Modeling Can Help 247\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eChris Antoniou, Justin McCue, Venkatesh Natarajan, Jörg Thömmes, and Qing Sarah Yuan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 247\u003c\/p\u003e \u003cp\u003e8.2 Packing Quality: Why and How to Ensure Column Packing Quality Across Scales 248\u003c\/p\u003e \u003cp\u003e8.3 Process Equipment: Using CFD to Describe Effects of Equipment Design on Column Performance 257\u003c\/p\u003e \u003cp\u003e8.4 Long-Term Column Operation at Scale: Impact of Resin Lot-to-Lot Variability 264\u003c\/p\u003e \u003cp\u003e8.5 Closing Remarks 265\u003c\/p\u003e \u003cp\u003eReferences 265\u003c\/p\u003e \u003cp\u003e9 High-Throughput Process Development 269\u003cbr\u003e\u003ci\u003eSilvia M. Pirrung and Marcel Ottens\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction to High-Throughput Process Development in Chromatography 269\u003c\/p\u003e \u003cp\u003e9.2 Process Development Approaches 271\u003c\/p\u003e \u003cp\u003e9.3 Case Descriptions 279\u003c\/p\u003e \u003cp\u003e9.4 Future Directions 286\u003c\/p\u003e \u003cp\u003eReferences 286\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 High-Throughput Column Chromatography Performed on Liquid Handling Stations 293\u003c\/b\u003e\u003cbr\u003e\u003ci\u003ePatrick Diederich and Jürgen Hubbuch\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 293\u003c\/p\u003e \u003cp\u003e10.2 Chromatographic Methods 299\u003c\/p\u003e \u003cp\u003e10.3 Results and Discussion 300\u003c\/p\u003e \u003cp\u003e10.4 Summary and Conclusion 328\u003c\/p\u003e \u003cp\u003eAcknowledgements 329\u003c\/p\u003e \u003cp\u003eReferences 330\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Lab-Scale Development of Chromatography Processes 333\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eHong Li, Jennifer Pollard, and Nihal Tugcu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 333\u003c\/p\u003e \u003cp\u003e11.2 Methodology and Proposed Workflow 336\u003c\/p\u003e \u003cp\u003e11.3 Conclusions 377\u003c\/p\u003e \u003cp\u003eAcknowledgments 377\u003c\/p\u003e \u003cp\u003eReferences 377\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Problem Solving by Using Modeling 381\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eMartin P. Breil, Søren S. Frederiksen, Steffen Kidal, and Thomas B. Hansen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 381\u003c\/p\u003e \u003cp\u003e12.2 Theory 382\u003c\/p\u003e \u003cp\u003e12.3 Materials and Methods 385\u003c\/p\u003e \u003cp\u003e12.4 Determination of Model Parameters 385\u003c\/p\u003e \u003cp\u003e12.5 Optimization In Silico 388\u003c\/p\u003e \u003cp\u003e12.6 Extra-Column Effects 390\u003c\/p\u003e \u003cp\u003eAbbreviations 397\u003c\/p\u003e \u003cp\u003eReferences 398\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Modeling Preparative Cation Exchange Chromatography of Monoclonal Antibodies 399\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eStephen Hunt, Trent Larsen, and Robert J. Todd\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 399\u003c\/p\u003e \u003cp\u003e13.2 Theory 401\u003c\/p\u003e \u003cp\u003e13.3 Model Development 403\u003c\/p\u003e \u003cp\u003e13.4 Model Application 413\u003c\/p\u003e \u003cp\u003e13.5 Conclusions 424\u003c\/p\u003e \u003cp\u003eNomenclature 425\u003c\/p\u003e \u003cp\u003eGreek letters 425\u003c\/p\u003e \u003cp\u003eReferences 426\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Model-Based Process Development in the Biopharmaceutical Industry 429\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eLars Sejergaard, Haleh Ahmadian, Thomas B. Hansen, Arne Staby, and Ernst B. Hansen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 429\u003c\/p\u003e \u003cp\u003e14.2 Molecule—FVIII 430\u003c\/p\u003e \u003cp\u003e14.3 Overall Process Design 431\u003c\/p\u003e \u003cp\u003e14.4 Use of Mathematical Models to Ensure Process Robustness 432\u003c\/p\u003e \u003cp\u003e14.5 Experimental Design of Verification Experiments 435\u003c\/p\u003e \u003cp\u003e14.6 Discussion 438\u003c\/p\u003e \u003cp\u003e14.7 Conclusion 439\u003c\/p\u003e \u003cp\u003eAcknowledgements 439\u003c\/p\u003e \u003cp\u003eAppendix 14.A Practical MATLAB Guideline to SEC 439\u003c\/p\u003e \u003cp\u003eAppendix 14.B Derivation of Models Used for Column Simulations 449\u003c\/p\u003e \u003cp\u003eReferences 455\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Dynamic Simulations as a Predictive Model for a Multicolumn Chromatography Separation 457\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eMarc Bisschops and Mark Brower\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 457\u003c\/p\u003e \u003cp\u003e15.2 BioSMB Technology 459\u003c\/p\u003e \u003cp\u003e15.3 Protein A Model Description 460\u003c\/p\u003e \u003cp\u003e15.4 Fitting the Model Parameters 463\u003c\/p\u003e \u003cp\u003e15.5 Case Studies 464\u003c\/p\u003e \u003cp\u003e15.6 Results for Continuous Chromatography 469\u003c\/p\u003e \u003cp\u003e15.7 Conclusions 475\u003c\/p\u003e \u003cp\u003eReferences 476\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Chemometrics Applications in Process Chromatography 479\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eAnurag S. Rathore and Sumit K. Singh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 479\u003c\/p\u003e \u003cp\u003e16.2 Data Types 480\u003c\/p\u003e \u003cp\u003e16.3 Data Preprocessing 481\u003c\/p\u003e \u003cp\u003e16.4 Modeling Approaches 485\u003c\/p\u003e \u003cp\u003e16.5 Case Studies of Use of Chemometrics in Process Chromatography 490\u003c\/p\u003e \u003cp\u003e16.6 Guidance on Performing MVDA 495\u003c\/p\u003e \u003cp\u003eReferences 497\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Mid-UV Protein Absorption Spectra and Partial Least Squares Regression as Screening and PAT Tool 501\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eSigrid Hansen, Nina Brestrich, Arne Staby, and Jürgen Hubbuch\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 501\u003c\/p\u003e \u003cp\u003e17.2 Mid-UV Protein Absorption Spectra and Partial Least Squares Regression 503\u003c\/p\u003e \u003cp\u003e17.3 Spectral Similarity and Prediction Precision 511\u003c\/p\u003e \u003cp\u003e17.4 Application as a Screening Tool: Analytics for High-Throughput Experiments 516\u003c\/p\u003e \u003cp\u003e17.5 Application as a PAT Tool: Selective In-line Quantification and Real-Time Pooling 518\u003c\/p\u003e \u003cp\u003e17.6 Case Studies 523\u003c\/p\u003e \u003cp\u003e17.7 Conclusion and Outlook 532\u003c\/p\u003e \u003cp\u003eReferences 532\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Recent Progress Toward More Sustainable Biomanufacturing: Practical Considerations for Use in the Downstream Processing of Protein Products 537\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eMilton T. W. Hearn\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 537\u003c\/p\u003e \u003cp\u003e18.2 The Impact of Individualized Unit Operations versus Integrated Platform Technologies on Sustainable Manufacturing 543\u003c\/p\u003e \u003cp\u003e18.3 Implications of Recycling and Reuse in Downstream Processing of Protein Products Generated by Biotechnological Processes: General Considerations 549\u003c\/p\u003e \u003cp\u003e18.4 Metrics and Valorization Methods to Assess Process Sustainability 553\u003c\/p\u003e \u003cp\u003e18.5 Conclusions and Perspectives 573\u003c\/p\u003e \u003cp\u003eAcknowledgment 573\u003c\/p\u003e \u003cp\u003eReferences 574\u003c\/p\u003e \u003cp\u003eIndex 583\u003c\/p\u003e \u003cp\u003e\u003cb\u003eARNE STABY\u003c\/b\u003e is a Fellow and Senior Principal Scientist at Novo Nordisk A\/S, Denmark, and the author of numerous papers and presentations in the field.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eANURAG S. RATHORE\u003c\/b\u003e 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 \u003ci\u003eQuality by Design for Biopharmaceuticals: Principles and Case Studies\u003c\/i\u003e (Wiley, 2009). \u003c\/p\u003e\u003cp\u003e\u003cb\u003eSATINDER AHUJA\u003c\/b\u003e is President of Ahuja Consulting, USA, and the author\/editor of numerous books including \u003ci\u003eChiral Separation Methods for Pharmaceutical and Biotechnological Products\u003c\/i\u003e (Wiley, 2010), \u003ci\u003eTrace and Ultratrace Analysis by HPLC\u003c\/i\u003e (Wiley, 1992), and \u003ci\u003eSelectivity and Detectability Optimizations in HPLC \u003c\/i\u003e(Wiley, 1989).  \u003c\/p\u003e\u003cp\u003ePreparative 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.\u003c\/p\u003e \u003cp\u003eWritten for those biotechnologists, biochemists, pharmaceutical scientists, and engineers working on this aspect of drug development, \u003ci\u003ePreparative Chromatography for Separation of Proteins \u003c\/i\u003eaddresses a wide range of modeling techniques, strategies, and case studies of industrial separation of proteins and peptides. \u003c\/p\u003e\u003cp\u003eChapters 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. \u003c\/p\u003e\u003cp\u003eWith its unique pairing of academic and industrial perspectives, this book is an indispensable resource for all those involved in the purification of biopharmaceuticals.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989841789157,"sku":"NP9781119031109","price":208.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119031109.jpg?v=1761785649","url":"https:\/\/k12savings.com\/es\/products\/preparative-chromatography-for-separation-of-proteins-isbn-9781119031109","provider":"K12savings","version":"1.0","type":"link"}