{"product_id":"singleuse-technology-in-biopharmaceutical-manufacture-9781119477839","title":"SingleUse Technology in Biopharmaceutical","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cb\u003eAuthoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe revised and updated second edition of \u003ci\u003eSingle-Use Technology in Biopharmaceutical Manufacture\u003c\/i\u003e offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authorsnoted experts on the topicprovide the essential information on the principles, characteristics, engineering aspects, economics, and applications.\u003c\/p\u003e \u003cp\u003eThis authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals' applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The bo\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003eList of Contributors xvii\u003c\/p\u003e \u003cp\u003ePreface xxi\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Basics 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Single‐Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction 3\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eDieter Eibl and Regine Eibl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Background 3\u003c\/p\u003e \u003cp\u003e1.2 Terminology and Features 3\u003c\/p\u003e \u003cp\u003e1.3 Single‐Use Systems in Production Processes for Therapeutic Proteins such as mAbs: Product Overview and Classification 5\u003c\/p\u003e \u003cp\u003e1.4 Single‐Use Production Facilities 7\u003c\/p\u003e \u003cp\u003e1.5 Summary and Conclusions 7\u003c\/p\u003e \u003cp\u003eNomenclature 9\u003c\/p\u003e \u003cp\u003eReferences 9\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Types of Single‐Use Bag Systems and Integrity Testing Methods 13\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJens Rumsfeld and Regine Eibl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 13\u003c\/p\u003e \u003cp\u003e2.2 Bags for Fluid and Powder Handling 13\u003c\/p\u003e \u003cp\u003e2.3 Bag‐Handling and Container Systems 15\u003c\/p\u003e \u003cp\u003e2.4 Single‐Use Bag Systems for Freezing and Thawing 18\u003c\/p\u003e \u003cp\u003e2.5 Container Closure Integrity Testing 18\u003c\/p\u003e \u003cp\u003e2.6 Summary and Conclusions 22\u003c\/p\u003e \u003cp\u003eNomenclature 22\u003c\/p\u003e \u003cp\u003eReferences 22\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Mixing Systems for Single‐Use 25\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eS\u003ci\u003eö\u003c\/i\u003eren Werner, Matthias Kraume, and Dieter Eibl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 25\u003c\/p\u003e \u003cp\u003e3.2 The Mixing Process 25\u003c\/p\u003e \u003cp\u003e3.3 Single‐Use Bag Mixing Systems 27\u003c\/p\u003e \u003cp\u003e3.4 Summary and Conclusions 33\u003c\/p\u003e \u003cp\u003eNomenclature 33\u003c\/p\u003e \u003cp\u003eReferences 33\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Single‐Use Bioreactors – An Overview 37\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eValentin Jossen, Regine Eibl, and Dieter Eibl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 37\u003c\/p\u003e \u003cp\u003e4.2 SUB History 38\u003c\/p\u003e \u003cp\u003e4.3 Comparison of the Current, Most Common SUB Types 40\u003c\/p\u003e \u003cp\u003e4.4 Decision Criteria for Selection of the Most Suitable SUB Type 47\u003c\/p\u003e \u003cp\u003e4.5 Summary and Future Trends 48\u003c\/p\u003e \u003cp\u003eNomenclature 48\u003c\/p\u003e \u003cp\u003eReferences 48\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Systems for Coupling and Sampling 53\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eCedric Schirmer, Sebastian Rothe, Ernest Jenness, and Dieter Eibl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 53\u003c\/p\u003e \u003cp\u003e5.2 Components of Single‐Use Transfer Lines 53\u003c\/p\u003e \u003cp\u003e5.3 Systems for Aseptic Coupling 57\u003c\/p\u003e \u003cp\u003e5.4 Aseptic Disconnection 62\u003c\/p\u003e \u003cp\u003e5.5 Systems for Sampling 64\u003c\/p\u003e \u003cp\u003e5.6 Summary and Conclusion 66\u003c\/p\u003e \u003cp\u003eNomenclature 66\u003c\/p\u003e \u003cp\u003eReferences 66\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Sensors for Disposable Bioreactor Systems 69\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eTobias Steinwedel, Katharina Dahlmann, D\u003ci\u003eö\u003c\/i\u003erte Solle, Thomas Scheper, Kenneth F. Reardon, and Frank Lammers\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 69\u003c\/p\u003e \u003cp\u003e6.2 Interfaces for Sensor Technology 70\u003c\/p\u003e \u003cp\u003e6.3 Considerations of Extractables and Leachables from Integrated Sensors 71\u003c\/p\u003e \u003cp\u003e6.4 Optical Chemosensors 72\u003c\/p\u003e \u003cp\u003e6.5 Spectroscopic Sensors 73\u003c\/p\u003e \u003cp\u003e6.6 Capacitance Sensors 75\u003c\/p\u003e \u003cp\u003e6.7 Electrochemical Sensors 76\u003c\/p\u003e \u003cp\u003e6.8 Biosensors 78\u003c\/p\u003e \u003cp\u003e6.9 Conclusions and Outlook 78\u003c\/p\u003e \u003cp\u003eNomenclature 79\u003c\/p\u003e \u003cp\u003eReferences 79\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Bioinformatics and Single‐Use 83\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eBarbara A. Paldus\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 83\u003c\/p\u003e \u003cp\u003e7.2 Bioinformatics and Single‐Use 84\u003c\/p\u003e \u003cp\u003e7.3 Smart Sensors 86\u003c\/p\u003e \u003cp\u003e7.4 Intelligent Control Systems 87\u003c\/p\u003e \u003cp\u003e7.5 Continuous Processing 88\u003c\/p\u003e \u003cp\u003e7.6 Conclusions 92\u003c\/p\u003e \u003cp\u003eNomenclature 94\u003c\/p\u003e \u003cp\u003eReferences 94\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Production of Disposable Bags: A Manufacturer’s Report 95\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eSteven Vanhamel and Catherine Piton\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 95\u003c\/p\u003e \u003cp\u003e8.2 Materials 95\u003c\/p\u003e \u003cp\u003e8.4 Bag Manufacturing 110\u003c\/p\u003e \u003cp\u003e8.5 Summary and Conclusions 113\u003c\/p\u003e \u003cp\u003eNomenclature 115\u003c\/p\u003e \u003cp\u003eReferences 116\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Single‐Use Downstream Processing for Biopharmaceuticals: Current State and Trends 117\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eBritta Manser, Martin Glenz, and Marc Bisschops\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 117\u003c\/p\u003e \u003cp\u003e9.2 Single‐Use DSP Today 117\u003c\/p\u003e \u003cp\u003e9.3 Technologies in Single-Use DSP 120\u003c\/p\u003e \u003cp\u003e9.4 Single‐Use Continuous Downstream Processing 121\u003c\/p\u003e \u003cp\u003e9.5 Integrated and Continuous DSP 124\u003c\/p\u003e \u003cp\u003e9.6 Summary and Conclusions 124\u003c\/p\u003e \u003cp\u003eNomenclature 124\u003c\/p\u003e \u003cp\u003eReferences 125\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Application of Microporous Filtration in Single‐Use Systems 127\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eChristian Julien and Chuck Capron\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 127\u003c\/p\u003e \u003cp\u003e10.2 Microporous Filters 128\u003c\/p\u003e \u003cp\u003e10.3 Filter Selection 134\u003c\/p\u003e \u003cp\u003e10.4 Final Sterile Filtration 136\u003c\/p\u003e \u003cp\u003e10.5 Filter Integrity Testing 138\u003c\/p\u003e \u003cp\u003e10.6 Filter Qualification and Validation 139\u003c\/p\u003e \u003cp\u003e10.7 Summary and Conclusions 140\u003c\/p\u003e \u003cp\u003eNomenclature 140\u003c\/p\u003e \u003cp\u003eReferences 140\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Extractables\/Leachables from Single‐Use Equipment: Considerations from a (Bio) Pharmaceutical Manufacturer 143\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAlicja Sobańtka and Christian Weiner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 143\u003c\/p\u003e \u003cp\u003e11.2 Regulatory Environment 144\u003c\/p\u003e \u003cp\u003e11.3 The (Bio)Pharmaceutical Manufacturer’s Approach 146\u003c\/p\u003e \u003cp\u003e11.4 The (Bio)Pharmaceutical Manufacturer’s Challenges 153\u003c\/p\u003e \u003cp\u003e11.5 Summary 155\u003c\/p\u003e \u003cp\u003e11.6 Discussion and Outlook 156\u003c\/p\u003e \u003cp\u003eAcknowledgments 156\u003c\/p\u003e \u003cp\u003eNomenclature 157\u003c\/p\u003e \u003cp\u003eReferences 157\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 The Single‐Use Standardization 159\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eP.E. James Dean Vogel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 159\u003c\/p\u003e \u003cp\u003e12.2 Alphabet Soup 159\u003c\/p\u003e \u003cp\u003e12.3 History 161\u003c\/p\u003e \u003cp\u003e12.4 Compare and Contrast 161\u003c\/p\u003e \u003cp\u003e12.5 Collaboration and Alignment Lead to Standardization 162\u003c\/p\u003e \u003cp\u003e12.6 General SUT Efforts 163\u003c\/p\u003e \u003cp\u003e12.7 Leachables and Extractables 164\u003c\/p\u003e \u003cp\u003e12.8 Particulates in SUT 164\u003c\/p\u003e \u003cp\u003e12.9 Change Notification 165\u003c\/p\u003e \u003cp\u003e12.10 SUT System Integrity 165\u003c\/p\u003e \u003cp\u003e12.11 SUT User Requirements 165\u003c\/p\u003e \u003cp\u003e12.12 Connectors 165\u003c\/p\u003e \u003cp\u003e12.13 SUT Design Verification 165\u003c\/p\u003e \u003cp\u003e12.14 Summary and Conclusions 166\u003c\/p\u003e \u003cp\u003eNomenclature 166\u003c\/p\u003e \u003cp\u003eReferences 166\u003c\/p\u003e \u003cp\u003eFurther Reading 166\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Environmental Impacts of Single‐Use Systems 169\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eWilliam G. Whitford, Mark A. Petrich, and William P. Flanagan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 169\u003c\/p\u003e \u003cp\u003e13.2 Sustainability 169\u003c\/p\u003e \u003cp\u003e13.3 The Evolution of SU Technologies 169\u003c\/p\u003e \u003cp\u003e13.4 Implications in Sustainability 172\u003c\/p\u003e \u003cp\u003e13.5 LCA – A Holistic Methodology 172\u003c\/p\u003e \u003cp\u003e13.6 LCA Applied to SU Technologies 173\u003c\/p\u003e \u003cp\u003e13.7 Sustainability Efforts in the BioPharma Industry 175\u003c\/p\u003e \u003cp\u003e13.8 End‐of‐Life (Waste) Management 177\u003c\/p\u003e \u003cp\u003e13.9 Summary and Conclusions 178\u003c\/p\u003e \u003cp\u003eNomenclature 178\u003c\/p\u003e \u003cp\u003eReferences 178\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Design Considerations Towards an Intensified Single‐Use Facility 181\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eGerben Zijlstra, Kai Touw, Michael Koch, and Miriam Monge\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 181\u003c\/p\u003e \u003cp\u003e14.2 Moving Towards Intensified and Continuous Processing 181\u003c\/p\u003e \u003cp\u003e14.3 Methodologies for Continuous and Intensified Single‐Use Bioprocessing 183\u003c\/p\u003e \u003cp\u003e14.4 Process Development for Intensified Biomanufacturing Facilities 184\u003c\/p\u003e \u003cp\u003e14.5 The Intensified Biomanufacturing Facility 184\u003c\/p\u003e \u003cp\u003e14.6 Process Automation for Commercial Manufacturing Facilities 187\u003c\/p\u003e \u003cp\u003e14.7 Intensified Upstream Processing 187\u003c\/p\u003e \u003cp\u003e14.8 Intensified Downstream Processing 189\u003c\/p\u003e \u003cp\u003e14.9 Summary and Conclusions 191\u003c\/p\u003e \u003cp\u003eAcknowledgments 191\u003c\/p\u003e \u003cp\u003eNomenclature 191\u003c\/p\u003e \u003cp\u003eReferences 191\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Single‐Use Technologies in Biopharmaceutical Manufacturing: A 10‐Year Review of Trends and the Future 193\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eRonald A. Rader and Eric S. Langer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 193\u003c\/p\u003e \u003cp\u003e15.2 Background 193\u003c\/p\u003e \u003cp\u003e15.3 Methods 194\u003c\/p\u003e \u003cp\u003e15.4 Results 194\u003c\/p\u003e \u003cp\u003e15.5 Discussion 197\u003c\/p\u003e \u003cp\u003e15.6 Conclusions 199\u003c\/p\u003e \u003cp\u003eNomenclature 200\u003c\/p\u003e \u003cp\u003eReferences 200\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Application Reports and Case Studies 201\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Single‐Use Process Platforms for Responsive and Cost‐Effective Manufacturing 203\u003cbr\u003e\u003c\/b\u003e\u003ci\u003ePriyanka Gupta, Miriam Monge, Amelie Boulais, Nitin Chopra, and Nick Hutchinson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 203\u003c\/p\u003e \u003cp\u003e16.2 Standardized Single‐Use Process Platforms for Biomanufacturing 204\u003c\/p\u003e \u003cp\u003e16.3 Implementing Single‐Use Process Platforms 204\u003c\/p\u003e \u003cp\u003e16.4 Economic Analysis Comparing Stainless Steel with Single‐Use Process Platforms 207\u003c\/p\u003e \u003cp\u003e16.5 Summary and Conclusions 209\u003c\/p\u003e \u003cp\u003eNomenclature 209\u003c\/p\u003e \u003cp\u003eReferences 210\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Considerations on Performing Quality Risk Analysis for Production Processes with Single‐Use Systems 211\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eIna Pahl, Armin Hauk, Lydia Schosser, and Sonja von Orlikowski\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 211\u003c\/p\u003e \u003cp\u003e17.2 Quality Risk Assessment 211\u003c\/p\u003e \u003cp\u003e17.3 Terminology and Features 212\u003c\/p\u003e \u003cp\u003e17.4 Current Industrial Approach for Leachable Assessment in Biopharmaceutical Processes 212\u003c\/p\u003e \u003cp\u003e17.5 Holistic Approach to Predict Leachables for Quality Risk Assessment 214\u003c\/p\u003e \u003cp\u003e17.6 Summary and Conclusions 215\u003c\/p\u003e \u003cp\u003eNomenclature 217\u003c\/p\u003e \u003cp\u003eReferences 217\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 How to Assure Robustness, Sterility, and Performance of Single‐Use Systems: A Quality Approach from the Manufacturer’s Perspective 219\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eSimone Biel and Sara Bell\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 219\u003c\/p\u003e \u003cp\u003e18.2 Component Qualification 219\u003c\/p\u003e \u003cp\u003e18.3 Validation of Product Design 220\u003c\/p\u003e \u003cp\u003e18.4 Manufacturing and Control 224\u003c\/p\u003e \u003cp\u003e18.5 Operator Training, Performance Culture 225\u003c\/p\u003e \u003cp\u003e18.6 Particulate Risk Mitigation 225\u003c\/p\u003e \u003cp\u003e18.7 Change Management 225\u003c\/p\u003e \u003cp\u003e18.8 Summary and Conclusions 226\u003c\/p\u003e \u003cp\u003eNomenclature 227\u003c\/p\u003e \u003cp\u003eReferences 227\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 How to Design and Qualify an Improved Film for Storage and Bioreactor Bags 229\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eLucie Delaunay, Elke Jurkiewicz, Gerhard Greller, and Magali Barbaroux\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction229\u003c\/p\u003e \u003cp\u003e19.2 Materials, Process, and Suppliers Selection 229\u003c\/p\u003e \u003cp\u003e19.3 Biological Properties 229\u003c\/p\u003e \u003cp\u003e19.4 Specifications and Process Design Space 231\u003c\/p\u003e \u003cp\u003e19.5 Process Control Strategy 233\u003c\/p\u003e \u003cp\u003e19.6 Summary and Conclusions 233\u003c\/p\u003e \u003cp\u003eNomenclature 233\u003c\/p\u003e \u003cp\u003eReferences 233\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 An Approach for Rapid Manufacture and Qualification of a Single‐Use Bioreactor Prototype 235\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eStephan C. Kaiser\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction 235\u003c\/p\u003e \u003cp\u003e20.2 About the Development Process of a Single‐Use Bioreactor 235\u003c\/p\u003e \u003cp\u003e20.3 Summary and Conclusions 243\u003c\/p\u003e \u003cp\u003eNomenclature 244\u003c\/p\u003e \u003cp\u003eReferences 244\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Single‐Use Bioreactor Platform for Microbial Fermentation 247\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eParrish M. Galliher, Patrick Guertin, Ken Clapp, Colin Tuohey, Rick Damren, Yasser Kehail, Vincent Colombie, and Andreas Castan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21.1 Introduction 247\u003c\/p\u003e \u003cp\u003e21.2 General Design Basis for Microbial SUFs 247\u003c\/p\u003e \u003cp\u003e21.3 SUF Design Criteria and Approach – Heat Transfer 247\u003c\/p\u003e \u003cp\u003e21.4 SUF Design Criteria and Approach – Oxygen Transfer 249\u003c\/p\u003e \u003cp\u003e21.5 SUF Design Criteria and Approach – Mixing 251\u003c\/p\u003e \u003cp\u003e21.6 Operational Considerations for SUFs 252\u003c\/p\u003e \u003cp\u003e21.7 Case Studies 252\u003c\/p\u003e \u003cp\u003e21.8 Summary and Conclusions 256\u003c\/p\u003e \u003cp\u003eNomenclature 257\u003c\/p\u003e \u003cp\u003eReferences 258\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 Engineering Parameters in Single‐Use Bioreactors: Flow, Mixing, Aeration, and Suspension 259\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMartina Micheletti and Andrea Ducci\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22.1 Introduction 259\u003c\/p\u003e \u003cp\u003e22.2 Stirred Bioreactors 259\u003c\/p\u003e \u003cp\u003e22.3 Orbitally Shaken Bioreactors 262\u003c\/p\u003e \u003cp\u003e22.4 Rocking Bag 267\u003c\/p\u003e \u003cp\u003e22.5 Summary and Conclusions 268\u003c\/p\u003e \u003cp\u003eNomenclature 268\u003c\/p\u003e \u003cp\u003eReferences 268\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 Alluvial Filtration: An Effective and Economical Solution for Midstream Application (e.g. Cell and Host Cell Protein Removal) 271\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eRalph Daumke, Vasily Medvedev, Tiago Albano, and Fabien Rousset\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23.1 Introduction 271\u003c\/p\u003e \u003cp\u003e23.2 Case Study 2: Cell Removal 272\u003c\/p\u003e \u003cp\u003e23.3 Case Study 2: HCP Removal 275\u003c\/p\u003e \u003cp\u003e23.4 Summary and Conclusions 276\u003c\/p\u003e \u003cp\u003eNomenclature 277\u003c\/p\u003e \u003cp\u003eReferences 277\u003c\/p\u003e \u003cp\u003e\u003cb\u003e24 Single‐Use Continuous Downstream Processing for Biopharmaceutical Products 279\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMarc Bisschops, Britta Manser, and Martin Glenz\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24.1 Introduction 279\u003c\/p\u003e \u003cp\u003e24.2 Continuous Multicolumn Chromatography 279\u003c\/p\u003e \u003cp\u003e24.3 Single‐Use Continuous Downstream Processing 280\u003c\/p\u003e \u003cp\u003e24.4 Summary and Conclusions 283\u003c\/p\u003e \u003cp\u003eReferences 283\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25 Single‐Use Technology for Formulation and Filling Applications 285\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eChristophe Pierlot, Alain Vanhecke, Kevin Thompson, Rainer Gloeckler, and Daniel Kehl\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25.1 Introduction 285\u003c\/p\u003e \u003cp\u003e25.2 Challenges in Formulation and Filling 285\u003c\/p\u003e \u003cp\u003e25.3 End‐User Requirements 286\u003c\/p\u003e \u003cp\u003e25.4 Quality by Design 287\u003c\/p\u003e \u003cp\u003e25.5 Hardware Design and Usability 288\u003c\/p\u003e \u003cp\u003e25.6 Single‐Use Technology, Arrangement, and Operation 290\u003c\/p\u003e \u003cp\u003e25.7 Summary and Conclusions 293\u003c\/p\u003e \u003cp\u003eNomenclature 294\u003c\/p\u003e \u003cp\u003eReferences 294\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26 Facility Design Considerations for Mammalian Cell Culture 295\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eSue Walker\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26.1 Introduction 295\u003c\/p\u003e \u003cp\u003e26.2 Generic Case Study 295\u003c\/p\u003e \u003cp\u003e26.3 Summary and Conclusions 301\u003c\/p\u003e \u003cp\u003eNomenclature 301\u003c\/p\u003e \u003cp\u003eReferences 301\u003c\/p\u003e \u003cp\u003e\u003cb\u003e27 Progress in the Development of Single‐Use Solutions in Antibody–Drug Conjugate (ADC) Manufacturing 303\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eDiego R. Schmidhalter, Stephan Elzner, and Romeo Schmid\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27.1 Introduction 303\u003c\/p\u003e \u003cp\u003e27.2 Challenges for the Use of Disposables in ADC Processes 304\u003c\/p\u003e \u003cp\u003e27.3 Key Unit Operations 306\u003c\/p\u003e \u003cp\u003e27.4 Cysteine Conjugation Process – An ADC Production Process Case Study 308\u003c\/p\u003e \u003cp\u003e27.5 Summary and Conclusions 309\u003c\/p\u003e \u003cp\u003eAcknowledgment 309\u003c\/p\u003e \u003cp\u003eNomenclature 309\u003c\/p\u003e \u003cp\u003eReferences 310\u003c\/p\u003e \u003cp\u003e\u003cb\u003e28 Single‐Use Processing as a Safe and Convenient Way to Develop and Manufacture Moss‐Derived Biopharmaceuticals 311\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eHolger Niederkr\u003ci\u003eü\u003c\/i\u003eger, Andreas Busch, Paulina Dabrowska‐Schlepp, Nicola Krieghoff, Andreas Schaaf, and Thomas Frischmuth\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28.1 Introduction 311\u003c\/p\u003e \u003cp\u003e28.2 Case Study 311\u003c\/p\u003e \u003cp\u003e28.3 Summary and Outlook 317\u003c\/p\u003e \u003cp\u003eNomenclature 317\u003c\/p\u003e \u003cp\u003eReferences 318\u003c\/p\u003e \u003cp\u003e\u003cb\u003e29 Single‐Use Technologies Used in Cell and Gene Therapy Manufacturing Need to Fulfill Higher and Novel Requirements: How Can this Challenge Be Addressed? 319\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAlain Pralong and Ang\u003ci\u003eé\u003c\/i\u003elique Palumbo\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e29.1 Introduction 319\u003c\/p\u003e \u003cp\u003e29.2 Promise of Cell and Gene Therapy 320\u003c\/p\u003e \u003cp\u003e29.3 Considerations for Biopharmaceutical Industry and Conclusion 322\u003c\/p\u003e \u003cp\u003eNomenclature 325\u003c\/p\u003e \u003cp\u003eReferences 325\u003c\/p\u003e \u003cp\u003e\u003cb\u003e30 Single‐Use Bioreactors for Manufacturing of Immune Cell Therapeutics 327\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eRalf P\u003ci\u003e\u003ci\u003eö\u003c\/i\u003e\u003c\/i\u003ertner, Christian Sebald, Shreemanta K. Parida, and Hans Hoffmeister\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e30.1 Introduction 327\u003c\/p\u003e \u003cp\u003e30.2 The Particular Nature of Immune Cell Therapeutics 327\u003c\/p\u003e \u003cp\u003e30.3 Uncertain Mass Production of Immune Cells for Therapy 328\u003c\/p\u003e \u003cp\u003e30.4 Technical Standards Required for Immune Cell ATMP Manufacturing 329\u003c\/p\u003e \u003cp\u003e30.5 Techniques for Expansion of Immune Cells 329\u003c\/p\u003e \u003cp\u003e30.6 Case Study ZRP System Consisting of GMP Breeder, Control Unit, and Software 330\u003c\/p\u003e \u003cp\u003e30.7 Summary and Conclusions 330\u003c\/p\u003e \u003cp\u003eNomenclature 332\u003c\/p\u003e \u003cp\u003eReferences 332\u003c\/p\u003e \u003cp\u003eIndex 335\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49407062737239,"sku":"9781119477839","price":999.99,"currency_code":"GBP","in_stock":false}],"url":"https:\/\/bookcurl.com\/products\/singleuse-technology-in-biopharmaceutical-manufacture-9781119477839","provider":"Book Curl","version":"1.0","type":"link"}