{"product_id":"process-scale-purification-of-antibodies-9781119126911","title":"Process Scale Purification of Antibodies","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003ePromoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification.\u003cbr\u003e\u003cbr\u003e Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing\u003cbr\u003e Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification\u003cbr\u003e Emphasizes antibodies and innovative chromatography methods for processing\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface xxiii\u003c\/p\u003e \u003cp\u003eList of Contributors xxvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities 1\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eBrian Kelley\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 A Brief History of Current Good Manufacturing Process mAb and Intravenous Immunoglobulin Purification 2\u003c\/p\u003e \u003cp\u003e1.3 Current Approaches in Purification Process Development: Impact of Platform Processes 4\u003c\/p\u003e \u003cp\u003e1.4 Typical Unit Operations and Processing Alternatives 7\u003c\/p\u003e \u003cp\u003e1.5 VLS Processes: Ton‐Scale Production and Beyond 10\u003c\/p\u003e \u003cp\u003e1.6 Process Validation 12\u003c\/p\u003e \u003cp\u003e1.7 Product Life Cycle Management 13\u003c\/p\u003e \u003cp\u003e1.8 Future Opportunities 16\u003c\/p\u003e \u003cp\u003e1.9 Conclusions 18\u003c\/p\u003e \u003cp\u003eAcknowledgments 19\u003c\/p\u003e \u003cp\u003eReferences 19\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 The Development of Antibody Purification Technologies 23\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJohn Curling\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 23\u003c\/p\u003e \u003cp\u003e2.2 Purification of Antibodies by Chromatography Before Protein A 25\u003c\/p\u003e \u003cp\u003e2.3 Antibody Purification After 1975 28\u003c\/p\u003e \u003cp\u003e2.4 Additional Technologies for Antibody Purification 31\u003c\/p\u003e \u003cp\u003e2.5 Purification of mAbs Approved in North America and Europe 34\u003c\/p\u003e \u003cp\u003e2.6 Current Antibody Process Technology Developments 40\u003c\/p\u003e \u003cp\u003eAcknowledgments 45\u003c\/p\u003e \u003cp\u003eReferences 46\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification 55\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAbhinav A. Shukla and Eric Suda\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 55\u003c\/p\u003e \u003cp\u003e3.2 Centrifugation 59\u003c\/p\u003e \u003cp\u003e3.3 Microfiltration 62\u003c\/p\u003e \u003cp\u003e3.4 Depth Filtration 67\u003c\/p\u003e \u003cp\u003e3.5 Flocculation 70\u003c\/p\u003e \u003cp\u003e3.6 Absolute Filtration 71\u003c\/p\u003e \u003cp\u003e3.7 Expanded Bed Adsorption Chromatography 73\u003c\/p\u003e \u003cp\u003e3.8 Harvesting in Single‐Use Manufacturing 74\u003c\/p\u003e \u003cp\u003e3.9 Comparison of Harvest and Clarification Unit Operations 74\u003c\/p\u003e \u003cp\u003eReferences 76\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Next‐Generation Clarification Technologies for the Downstream Processing of Antibodies 81\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eNripen Singh and Srinivas Chollangi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 81\u003c\/p\u003e \u003cp\u003e4.2 Impurity Profiles in Cell Cultures 83\u003c\/p\u003e \u003cp\u003e4.3 Precipitation 84\u003c\/p\u003e \u003cp\u003e4.4 Affinity Precipitation 89\u003c\/p\u003e \u003cp\u003e4.5 Flocculation 90\u003c\/p\u003e \u003cp\u003e4.6 Toxicity of Flocculants and Precipitants and Their Residual Clearance 96\u003c\/p\u003e \u003cp\u003e4.7 Depth Filtration 97\u003c\/p\u003e \u003cp\u003e4.8 Considerations for the Implementation of New Clarification Technologies 102\u003c\/p\u003e \u003cp\u003e4.9 Conclusions and Future Perspectives 103\u003c\/p\u003e \u003cp\u003eAcknowledgments 104\u003c\/p\u003e \u003cp\u003eReferences 104\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Protein A‐Based Affinity Chromatography 113\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eSuresh Vunnum, Ganesh Vedantham and Brian Hubbard\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 113\u003c\/p\u003e \u003cp\u003e5.2 Properties of Protein A and Commercially Available Protein A Resins 114\u003c\/p\u003e \u003cp\u003e5.3 Protein A Chromatography Step Development 118\u003c\/p\u003e \u003cp\u003e5.4 Additional Considerations During Development and Scale‐Up 123\u003c\/p\u003e \u003cp\u003e5.5 Virus Removal\/Inactivation 127\u003c\/p\u003e \u003cp\u003e5.6 Validation and Robustness 128\u003c\/p\u003e \u003cp\u003e5.7 Conclusions 129\u003c\/p\u003e \u003cp\u003eAcknowledgment 130\u003c\/p\u003e \u003cp\u003eReferences 130\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Purification of Human Monoclonal Antibodies: Non‐Protein A Strategies 135\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAlahari Arunakumari and Jue Wang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 135\u003c\/p\u003e \u003cp\u003e6.2 Integrated Process Design for Human Monoclonal Antibody Production 136\u003c\/p\u003e \u003cp\u003e6.3 Purification Process Designs for HuMabs 136\u003c\/p\u003e \u003cp\u003e6.4 Conclusions 149\u003c\/p\u003e \u003cp\u003eAcknowledgments 151\u003c\/p\u003e \u003cp\u003eReferences 152\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Hydrophobic Interaction Chromatography for the Purification of Antibodies 155\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJudith Vajda and Egbert Muller\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 155\u003c\/p\u003e \u003cp\u003e7.2 HIC With mAbs 156\u003c\/p\u003e \u003cp\u003e7.3 HIC with Membrane Adsorbers 173\u003c\/p\u003e \u003cp\u003e7.4 Future Perspectives 174\u003c\/p\u003e \u003cp\u003eReferences 175\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Purification of Monoclonal Antibodies by Mixed‐Mode Chromatography 181\u003cbr\u003e\u003c\/b\u003e\u003ci\u003ePete Gagnon\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 181\u003c\/p\u003e \u003cp\u003e8.2 A Brief History 182\u003c\/p\u003e \u003cp\u003e8.3 Prerequisites for Industrial Implementation 183\u003c\/p\u003e \u003cp\u003e8.4 Mechanisms, Screening, and Method Development 185\u003c\/p\u003e \u003cp\u003e8.5 Capture Applications 192\u003c\/p\u003e \u003cp\u003e8.6 Polishing Applications 193\u003c\/p\u003e \u003cp\u003e8.7 Sequential Capture\/Polishing Applications 193\u003c\/p\u003e \u003cp\u003e8.8 Future Prospects 193\u003c\/p\u003e \u003cp\u003eAcknowledgments 194\u003c\/p\u003e \u003cp\u003eReferences 194\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Advances in Technology and Process Development for Industrial‐Scale Monoclonal Antibody Purification 199\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eNuno Fontes and Robert Van Reis\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 199\u003c\/p\u003e \u003cp\u003e9.2 Affinity Purification Platform 200\u003c\/p\u003e \u003cp\u003e9.3 Advances in the Purification of mAbs by CEX Chromatography 201\u003c\/p\u003e \u003cp\u003e9.4 High‐Performance Tangential Flow Filtration 209\u003c\/p\u003e \u003cp\u003e9.5 A New Nonaffinity Platform 211\u003c\/p\u003e \u003cp\u003eReferences 213\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Alternatives to Packed‐Bed Chromatography for Antibody Extraction and Purification 215\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJorg Thommes, Richard M. Twyman and Uwe Gottschalk\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 215\u003c\/p\u003e \u003cp\u003e10.2 Increasing the Selectivity of Harvest Procedures: Flocculation and Filter Aids 216\u003c\/p\u003e \u003cp\u003e10.3 Solutions for Antibody Extraction, Concentration, and Purification 218\u003c\/p\u003e \u003cp\u003e10.4 Antibody Purification and Formulation Without Chromatography 220\u003c\/p\u003e \u003cp\u003e10.5 Membrane Adsorbers 223\u003c\/p\u003e \u003cp\u003e10.6 Conclusions 225\u003c\/p\u003e \u003cp\u003eReferences 226\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Process‐Scale Precipitation of Impurities in Mammalian Cell Culture Broth 233\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJudy Glynn\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 233\u003c\/p\u003e \u003cp\u003e11.2 Precipitation of DNA and Protein—Other Applications 235\u003c\/p\u003e \u003cp\u003e11.3 A Comprehensive Evaluation of Precipitants for the Removal of Impurities 236\u003c\/p\u003e \u003cp\u003e11.4 Industrial‐Scale Precipitation 241\u003c\/p\u003e \u003cp\u003e11.5 Cost of Goods Comparison 243\u003c\/p\u003e \u003cp\u003e11.6 Summary 244\u003c\/p\u003e \u003cp\u003eAcknowledgments 244\u003c\/p\u003e \u003cp\u003eReferences 244\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Charged Ultrafiltration and Microfiltration Membranes for Antibody Purification 247\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMark R. Etzel and Abhiram Arunkumar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 247\u003c\/p\u003e \u003cp\u003e12.2 Charged UF Membranes 248\u003c\/p\u003e \u003cp\u003e12.3 Concentration Polarization and Permeate Flux 248\u003c\/p\u003e \u003cp\u003e12.4 Stagnant Film Model 249\u003c\/p\u003e \u003cp\u003e12.5 Sieving Coefficient 250\u003c\/p\u003e \u003cp\u003e12.6 Mass Transfer Coefficient 251\u003c\/p\u003e \u003cp\u003e12.7 Mass Balance Models 251\u003c\/p\u003e \u003cp\u003e12.8 Scale‐Up Strategies and the Constant Wall Concentration (\u003ci\u003eC\u003c\/i\u003e\u003csub\u003ew\u003c\/sub\u003e) Approach 253\u003c\/p\u003e \u003cp\u003e12.9 Membrane Cascades 255\u003c\/p\u003e \u003cp\u003e12.10 Protein Fractionation Using Charged UF Membranes 256\u003c\/p\u003e \u003cp\u003e12.11 Case Study 257\u003c\/p\u003e \u003cp\u003e12.12 Charged MF Membranes 259\u003c\/p\u003e \u003cp\u003e12.13 Virus Clearance 260\u003c\/p\u003e \u003cp\u003e12.14 Salt Tolerance 261\u003c\/p\u003e \u003cp\u003e12.15 Conclusions 264\u003c\/p\u003e \u003cp\u003eAcknowledgments 264\u003c\/p\u003e \u003cp\u003eReferences 264\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Disposable Prepacked‐Bed Chromatography for Downstream Purification: Form, Fit, Function, and Industry Adoption 269\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eStephen K. Tingley\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 269\u003c\/p\u003e \u003cp\u003e13.2 Development‐Scale Prepacked Column Applications 271\u003c\/p\u003e \u003cp\u003e13.3 Process‐Scale Prepacked Column Applications 275\u003c\/p\u003e \u003cp\u003e13.4 Basic Technical Datasets 278\u003c\/p\u003e \u003cp\u003e13.5 Independent Industry Assessments of “Fit for Purpose” 285\u003c\/p\u003e \u003cp\u003e13.6 Case Study 1: Cation‐Exchange Polishing Chromatography 285\u003c\/p\u003e \u003cp\u003e13.7 Case Study 2: Prepacked Columns for Pilot‐\/Large‐Scale Bioprocessing 287\u003c\/p\u003e \u003cp\u003e13.8 Prepacked Columns—Fit 292\u003c\/p\u003e \u003cp\u003e13.9 The Economics of Prepacked Column Technologies 295\u003c\/p\u003e \u003cp\u003e13.10 The Implementation of Disposable Prepacked Columns 297\u003c\/p\u003e \u003cp\u003e13.11 Conclusions 300\u003c\/p\u003e \u003cp\u003eReferences 301\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Integrated Polishing Steps for Monoclonal Antibody Purification 303\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eSanchayita Ghose, Mi Jin, Jia Liu, John Hickey and Steven Lee\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 303\u003c\/p\u003e \u003cp\u003e14.2 Polishing Steps for Antibody Purification 304\u003c\/p\u003e \u003cp\u003e14.3 Integration of Polishing Steps 316\u003c\/p\u003e \u003cp\u003e14.4 Conclusions 320\u003c\/p\u003e \u003cp\u003eAcknowledgment 320\u003c\/p\u003e \u003cp\u003eReferences 320\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Orthogonal Virus Clearance Applications in Monoclonal Antibody Production 325\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJoe X. Zhou\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 325\u003c\/p\u003e \u003cp\u003e15.2 Model Viruses and Virus Assays 326\u003c\/p\u003e \u003cp\u003e15.3 Virus Clearance Strategies at Different Development Stages 328\u003c\/p\u003e \u003cp\u003e15.4 Orthogonal Virus Clearance During mAb Production 328\u003c\/p\u003e \u003cp\u003e15.5 Conclusions and Future Perspectives 338\u003c\/p\u003e \u003cp\u003eAcknowledgments 339\u003c\/p\u003e \u003cp\u003eReferences 339\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Development of a Platform Process for the Purification of Therapeutic Monoclonal Antibodies 343\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eYuling Li, Min Zhu, Haibin Luo and Justin R. Weaver\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 343\u003c\/p\u003e \u003cp\u003e16.2 Chromatography Steps in the Platform Process 345\u003c\/p\u003e \u003cp\u003e16.3 Virus Inactivation 352\u003c\/p\u003e \u003cp\u003e16.4 UF\/DF Platform Considerations 352\u003c\/p\u003e \u003cp\u003e16.5 Platform Development: Virus Filtration and Bulk Fill 354\u003c\/p\u003e \u003cp\u003e16.6 Addressing Future Challenges in Downstream Processing 356\u003c\/p\u003e \u003cp\u003e16.7 Representative Platform Processes 356\u003c\/p\u003e \u003cp\u003e16.8 Developing a Virus Clearance Database Using a Platform Process 359\u003c\/p\u003e \u003cp\u003e16.9 Summary 361\u003c\/p\u003e \u003cp\u003eReferences 361\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 The Evolution of Platform Technologies for the Downstream Processing of Antibodies 365\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eLee Allen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 365\u003c\/p\u003e \u003cp\u003e17.2 The Definition of a Platform Purification Process 366\u003c\/p\u003e \u003cp\u003e17.3 The Dominant Process Design 367\u003c\/p\u003e \u003cp\u003e17.4 The Evolution of Unit Operations 372\u003c\/p\u003e \u003cp\u003e17.5 Adapting the Platform Process for Product‐Specific Issues 382\u003c\/p\u003e \u003cp\u003e17.6 Future Perspectives—Future Evolutionary Pathways 382\u003c\/p\u003e \u003cp\u003e17.7 Concluding Remarks 383\u003c\/p\u003e \u003cp\u003eAcknowledgments 384\u003c\/p\u003e \u003cp\u003eReferences 384\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Countercurrent Chromatography for the Purification of Monoclonal Antibodies, Bispecific Antibodies, and Antibody–Drug Conjugates 391\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eThomas Muller‐Spath and Massimo Morbidelli\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 391\u003c\/p\u003e \u003cp\u003e18.2 Chromatography to Reduce Product Heterogeneity 392\u003c\/p\u003e \u003cp\u003e18.3 Definition of Performance Parameters 394\u003c\/p\u003e \u003cp\u003e18.4 Gradient Chromatography for Biomolecules 394\u003c\/p\u003e \u003cp\u003e18.5 Continuous and Countercurrent Chromatography 395\u003c\/p\u003e \u003cp\u003e18.6 Multicolumn Countercurrent Solvent Gradient Purification 397\u003c\/p\u003e \u003cp\u003e18.7 Scalability of Multicolumn Countercurrent Chromatography 403\u003c\/p\u003e \u003cp\u003e18.8 Online Process Monitoring for Multicolumn Countercurrent Chromatography 404\u003c\/p\u003e \u003cp\u003e18.9 Outlook 405\u003c\/p\u003e \u003cp\u003eReferences 405\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 The Evolution of Continuous Chromatography: From Bulk Chemicals to Biopharma 409\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMarc Bisschops\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction 409\u003c\/p\u003e \u003cp\u003e19.2 Continuous Chromatography in Traditional Process Industries 410\u003c\/p\u003e \u003cp\u003e19.3 Continuous Chromatography in the Biopharmaceutical Industry 413\u003c\/p\u003e \u003cp\u003e19.4 Advantages of Continuous Chromatography 420\u003c\/p\u003e \u003cp\u003e19.5 Implementation Aspects of Continuous Chromatography 422\u003c\/p\u003e \u003cp\u003e19.6 Regulatory Aspects 424\u003c\/p\u003e \u003cp\u003e19.7 Conclusions 426\u003c\/p\u003e \u003cp\u003eReferences 427\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Accelerated Seamless Antibody Purification: Simplicity is Key 431\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eBenoit Mothes\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction 431\u003c\/p\u003e \u003cp\u003e20.2 Accelerated Seamless Antibody Purification 432\u003c\/p\u003e \u003cp\u003e20.3 Advantages of the ASAP Process 437\u003c\/p\u003e \u003cp\u003e20.4 Scaling Up the ASAP Process 438\u003c\/p\u003e \u003cp\u003e20.5 New Perspectives 440\u003c\/p\u003e \u003cp\u003e20.6 Conclusion 442\u003c\/p\u003e \u003cp\u003eAcknowledgments 442\u003c\/p\u003e \u003cp\u003eSuggested Reading 443\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Process Economic Drivers in Industrial Monoclonal Antibody Manufacture 445\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eSuzanne S. Farid\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21.1 Introduction 445\u003c\/p\u003e \u003cp\u003e21.2 Challenges When Striving for the Cost‐Effective Manufacture of mAbs 446\u003c\/p\u003e \u003cp\u003e21.3 Cost Definitions and Benchmark Values 448\u003c\/p\u003e \u003cp\u003e21.4 Economies of Scale 450\u003c\/p\u003e \u003cp\u003e21.5 Overall Process Economic Drivers 453\u003c\/p\u003e \u003cp\u003e21.6 DSP Drivers At High Titers 457\u003c\/p\u003e \u003cp\u003e21.7 Process Economic Trade‐Offs for Downstream Process Bottlenecks 459\u003c\/p\u003e \u003cp\u003e21.8 Summary and Outlook 461\u003c\/p\u003e \u003cp\u003eReferences 462\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 Design and Optimization of Manufacturing 467\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAndrew Sinclair\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22.1 Introduction 467\u003c\/p\u003e \u003cp\u003e22.2 Process Design and Optimization 468\u003c\/p\u003e \u003cp\u003e22.3 Modeling Approaches 470\u003c\/p\u003e \u003cp\u003e22.4 Process Modeling in Practice 481\u003c\/p\u003e \u003cp\u003e22.5 Impact of the Process on the Facility 491\u003c\/p\u003e \u003cp\u003eAcknowledgments 492\u003c\/p\u003e \u003cp\u003eReferences 492\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 Smart Design for an Efficient Facility With a Validated Disposable System 495\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJoe X. Zhou, Jason Li, Michael Cui and Haojun Chen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23.1 Design and Optimization of a Manufacturing Facility 495\u003c\/p\u003e \u003cp\u003e23.2 Validation of a Disposable System 507\u003c\/p\u003e \u003cp\u003e23.3 Conclusion 512\u003c\/p\u003e \u003cp\u003eAcknowledgments 512\u003c\/p\u003e \u003cp\u003eReferences 512\u003c\/p\u003e \u003cp\u003e\u003cb\u003e24 High‐Throughput Screening and Modeling Technologies for Process Development in Antibody Purification 515\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eTobias Hahn, Thiemo Huuk and Jurgen Hubbuch\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24.1 Introduction 515\u003c\/p\u003e \u003cp\u003e24.2 Adsorption Isotherms 516\u003c\/p\u003e \u003cp\u003e24.3 Batch Chromatography 519\u003c\/p\u003e \u003cp\u003e24.4 Column Chromatography 524\u003c\/p\u003e \u003cp\u003eReferences 532\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25 Downstream Processing of Monoclonal Antibody Fragments 537\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMariangela Spitali\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25.1 Introduction 537\u003c\/p\u003e \u003cp\u003e25.2 Production of Antibody Fragments for Therapeutic Use 538\u003c\/p\u003e \u003cp\u003e25.3 Downstream Processing 539\u003c\/p\u003e \u003cp\u003e25.4 Improving the Pharmacological Characteristics of Antibody Fragments 552\u003c\/p\u003e \u003cp\u003e25.5 Conclusions 553\u003c\/p\u003e \u003cp\u003eAcknowledgments 555\u003c\/p\u003e \u003cp\u003eReferences 555\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26 Downstream Processing of Fc Fusion Proteins, Bispecific Antibodies, and Antibody–Drug Conjugates 559\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAbhinav A. Shukla and Carnley L. Norman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26.1 Introduction 559\u003c\/p\u003e \u003cp\u003e26.2 Biochemical Properties 562\u003c\/p\u003e \u003cp\u003e26.3 Purification From Mammalian Expression Systems 576\u003c\/p\u003e \u003cp\u003e26.4 Purification From Microbial Production Systems 585\u003c\/p\u003e \u003cp\u003e26.5 Future Innovations 587\u003c\/p\u003e \u003cp\u003eAcknowledgment 589\u003c\/p\u003e \u003cp\u003eReferences 589\u003c\/p\u003e \u003cp\u003e\u003cb\u003e27 Manufacturing Concepts for Antibody–Drug Conjugates 595\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eThomas Rohrer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27.1 Introduction 595\u003c\/p\u003e \u003cp\u003e27.2 Targeting Components 596\u003c\/p\u003e \u003cp\u003e27.3 Cytotoxic Drugs 600\u003c\/p\u003e \u003cp\u003e27.4 Chemically Labile Linkers 602\u003c\/p\u003e \u003cp\u003e27.5 General Process Overview 602\u003c\/p\u003e \u003cp\u003e27.6 Facility Design and Supporting Technology 604\u003c\/p\u003e \u003cp\u003e27.7 Single‐Use Equipment 607\u003c\/p\u003e \u003cp\u003e27.8 Manufacturing ADCs 608\u003c\/p\u003e \u003cp\u003e27.9 Analytical Support for ADC Manufacturing 609\u003c\/p\u003e \u003cp\u003e27.10 Raw Materials Supply Chain 611\u003c\/p\u003e \u003cp\u003e27.11 Conclusion 611\u003c\/p\u003e \u003cp\u003eAcknowledgments 613\u003c\/p\u003e \u003cp\u003eReferences 613\u003c\/p\u003e \u003cp\u003e\u003cb\u003e28 Purification of IgM and IgA 615\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eCharlotte Cabanne and Xavier Santarelli\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28.1 Introduction 615\u003c\/p\u003e \u003cp\u003e28.2 Purification of IgM 616\u003c\/p\u003e \u003cp\u003e28.3 Purification of IgA 621\u003c\/p\u003e \u003cp\u003e28.4 Conclusion 623\u003c\/p\u003e \u003cp\u003eAcknowledgments 623\u003c\/p\u003e \u003cp\u003eReferences 623\u003c\/p\u003e \u003cp\u003e\u003cb\u003e29 Purification of Monoclonal Antibodies From Plants 631\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eZivko L. Nikolov, Jeffrey T. Regan, Lynn F. Dickey and Susan L. Woodard\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e29.1 Introduction 631\u003c\/p\u003e \u003cp\u003e29.2 Antibody Production in Plants 632\u003c\/p\u003e \u003cp\u003e29.3 Downstream Processing of Antibodies Produced in Plants 636\u003c\/p\u003e \u003cp\u003e29.4 Purification of Plant‐Derived Antibodies Using Protein A Resins 641\u003c\/p\u003e \u003cp\u003e29.5 Purification of Plant‐Derived Antibodies Using Non‐Protein A Media 642\u003c\/p\u003e \u003cp\u003e29.6 Polishing Steps 643\u003c\/p\u003e \u003cp\u003e29.7 Conclusions 645\u003c\/p\u003e \u003cp\u003eAcknowledgment 645\u003c\/p\u003e \u003cp\u003eReferences 645\u003c\/p\u003e \u003cp\u003e\u003cb\u003e30 Very‐Large‐Scale Production of Monoclonal Antibodies in Plants 655\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJohannes F. Buyel, Richard M. Twyman and Rainer Fischer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e30.1 Introduction 655\u003c\/p\u003e \u003cp\u003e30.2 Process Schemes for mAb Production in Plants 656\u003c\/p\u003e \u003cp\u003e30.3 Scalable Process Models 661\u003c\/p\u003e \u003cp\u003e30.4 Process Adaptation for VLS Requirements 663\u003c\/p\u003e \u003cp\u003e30.5 Translation into VLS Applications 666\u003c\/p\u003e \u003cp\u003eReferences 667\u003c\/p\u003e \u003cp\u003e\u003cb\u003e31 Trends in Formulation and Drug Delivery for Antibodies 673\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eHanns‐Christian Mahler and Roman Mathas\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e31.1 Introduction 673\u003c\/p\u003e \u003cp\u003e31.2 Degradation Pathways 674\u003c\/p\u003e \u003cp\u003e31.3 Physical Instability 674\u003c\/p\u003e \u003cp\u003e31.4 Chemical Instability 676\u003c\/p\u003e \u003cp\u003e31.5 How to Achieve Product Stability 678\u003c\/p\u003e \u003cp\u003e31.6 Developability: Molecule Selection and Elimination of Degradation Hotspots 679\u003c\/p\u003e \u003cp\u003e31.7 Stabilizing an Antibody in a Liquid Formulation 679\u003c\/p\u003e \u003cp\u003e31.8 Stabilizing an Antibody by Drying 681\u003c\/p\u003e \u003cp\u003e31.9 Choice of Adequate Primary Packaging 682\u003c\/p\u003e \u003cp\u003e31.10 Minimizing Stress During Drug Product Processing 683\u003c\/p\u003e \u003cp\u003e31.11 Implementation of a Formulation Strategy 685\u003c\/p\u003e \u003cp\u003e31.12 Hot Topics 685\u003c\/p\u003e \u003cp\u003e31.13 Summary 689\u003c\/p\u003e \u003cp\u003eReferences 690\u003c\/p\u003e \u003cp\u003e\u003cb\u003e32 Antibody Purification: Drivers of Change 699\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eNarahari Pujar, Duncan Low and Rhona O’Leary\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e32.1 Introduction 699\u003c\/p\u003e \u003cp\u003e32.2 The Changing Regulatory Environment—Pharmaceutical Manufacturing for the 21st Century 701\u003c\/p\u003e \u003cp\u003e32.3 Technology Drivers—Advances and Innovations 707\u003c\/p\u003e \u003cp\u003e32.4 Economic Drivers 708\u003c\/p\u003e \u003cp\u003e32.5 Conclusions 711\u003c\/p\u003e \u003cp\u003eAcknowledgment 712\u003c\/p\u003e \u003cp\u003eReferences 713\u003c\/p\u003e \u003cp\u003eIndex 717\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49406992744791,"sku":"9781119126911","price":168.26,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781119126911.jpg?v=1730497814","url":"https:\/\/bookcurl.com\/products\/process-scale-purification-of-antibodies-9781119126911","provider":"Book Curl","version":"1.0","type":"link"}