{"product_id":"bioprocessing-for-cellbased-therapies-9781118743416","title":"Bioprocessing for CellBased Therapies","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eWith contributions from leading, international academics and industrial practitioners, \u003ci\u003eBioprocessing for Cell-Based Therapies\u003c\/i\u003e explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells.\u003c\/p\u003e \u003cul\u003e \u003cli\u003eAn authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout\u003c\/li\u003e \u003cli\u003eAn authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout\u003c\/li\u003e \u003cli\u003eIn depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient\u003c\/li\u003e \u003cli\u003eIncludes contributions from experts in both academia and industry, combining a practical approach with cutting edge research\u003c\/li\u003e \u003cli\u003eThe only handbook currently available to provide a state of the art guide to\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eList of Contributors xi\u003c\/p\u003e \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Overview of the Cell Therapy Field 1\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMichael Whitaker, Lucy Foley and Stephen Ward\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 The Context of Cell Therapies and Their Manufacturing Challenges 1\u003c\/p\u003e \u003cp\u003e1.1.1 Regulation of Cell Therapies 4\u003c\/p\u003e \u003cp\u003e1.1.2 Manufacturing Challenges in Cell Therapy 5\u003c\/p\u003e \u003cp\u003e1.2 The Cell Therapy Landscape 5\u003c\/p\u003e \u003cp\u003e1.2.1 Licensed Cell Therapy Products 7\u003c\/p\u003e \u003cp\u003e1.2.2 Companies, Clinicians, Products and Procedures 8\u003c\/p\u003e \u003cp\u003e1.2.3 Cell Therapy Clinical Trials 8\u003c\/p\u003e \u003cp\u003e1.3 Operations in Cell Therapy Manufacture 11\u003c\/p\u003e \u003cp\u003e1.3.1 Cells for Cell Therapy Production 12\u003c\/p\u003e \u003cp\u003e1.3.1.1 Cell Source 12\u003c\/p\u003e \u003cp\u003e1.4 Upstream Processing of Cellular Therapies 13\u003c\/p\u003e \u003cp\u003e1.4.1 Cell Separation 13\u003c\/p\u003e \u003cp\u003e1.4.2 Cell Expansion 13\u003c\/p\u003e \u003cp\u003e1.4.3 Tissue Expansion 15\u003c\/p\u003e \u003cp\u003e1.4.4 Adherent Cell Expansion 15\u003c\/p\u003e \u003cp\u003e1.4.4.1 Multi-layer Reactors 15\u003c\/p\u003e \u003cp\u003e1.4.4.2 Hollow Fibre Reactors 16\u003c\/p\u003e \u003cp\u003e1.4.4.3 Scaffolds 17\u003c\/p\u003e \u003cp\u003e1.4.5 Suspension Cell Expansion 18\u003c\/p\u003e \u003cp\u003e1.4.5.1 Stirred Tank Bioreactors 18\u003c\/p\u003e \u003cp\u003e1.4.5.2 Rocking Platforms 19\u003c\/p\u003e \u003cp\u003e1.4.5.3 Perfusion Cell Culture 19\u003c\/p\u003e \u003cp\u003e1.4.6 Differentiation 19\u003c\/p\u003e \u003cp\u003e1.5 Downstream Processing of Cellular Therapies 20\u003c\/p\u003e \u003cp\u003e1.5.1 Harvest, Washing and Concentration 20\u003c\/p\u003e \u003cp\u003e1.5.1.1 Centrifugation 21\u003c\/p\u003e \u003cp\u003e1.5.1.2 Filtration 21\u003c\/p\u003e \u003cp\u003e1.5.2 Separation and Purification 22\u003c\/p\u003e \u003cp\u003e1.5.2.1 Centrifugation 22\u003c\/p\u003e \u003cp\u003e1.5.2.2 Magnetic Separation 24\u003c\/p\u003e \u003cp\u003e1.6 Formulation, Fill and Finish of Cellular Therapies 24\u003c\/p\u003e \u003cp\u003e1.6.1 Formulation 25\u003c\/p\u003e \u003cp\u003e1.6.2 Fill and Finish 25\u003c\/p\u003e \u003cp\u003e1.6.3 Preservation and Shipment 26\u003c\/p\u003e \u003cp\u003e1.7 Administration of the Cell Therapy to a Patient 27\u003c\/p\u003e \u003cp\u003e1.8 Cell Therapy Manufacturing Facilities of the Future 28\u003c\/p\u003e \u003cp\u003e1.8.1 Factory of the Future Requirements 31\u003c\/p\u003e \u003cp\u003e1.9 Conclusion 31\u003c\/p\u003e \u003cp\u003eReferences 32\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Structured Methodology for Process Development in Scalable Stirred Tank Bioreactors Platforms 35\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eHuaqing Wang, Daniel Kehoe, Julie Murrell and Donghui Jing\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 35\u003c\/p\u003e \u003cp\u003e2.2 Understanding the Engineering of the Stirred Tank Bioreactors 36\u003c\/p\u003e \u003cp\u003e2.2.1 Mixing Phenomena in Stirred Tank Bioreactors 37\u003c\/p\u003e \u003cp\u003e2.2.2 Understanding Oxygen Transfer Rate (kLa) with Different Sparging Methodologies 40\u003c\/p\u003e \u003cp\u003e2.2.3 Heat Transfer in STB (Minimum Volume, Sensor\/Sensing Control) 42\u003c\/p\u003e \u003cp\u003e2.2.4 How to Choose a Microcarrier for Adherent Cells (hMSCs) 43\u003c\/p\u003e \u003cp\u003e2.3 Understanding the Biology of the Cells in Stirred Tank Bioreactors (STB) 45\u003c\/p\u003e \u003cp\u003e2.3.1 Cell Types (Adherent and Suspension Cells) 45\u003c\/p\u003e \u003cp\u003e2.3.2 Assays for Comparability, Nutrients, Senescence and Doubling Dime 46\u003c\/p\u003e \u003cp\u003e2.4 Process Development of Adherent Cells in STB Platforms 47\u003c\/p\u003e \u003cp\u003e2.4.1 Standard Comparison to Cell Factory 47\u003c\/p\u003e \u003cp\u003e2.4.2 Methodology for Screening of Microcarriers 49\u003c\/p\u003e \u003cp\u003e2.4.3 Process Development in Small-scale Bioreactors (3L) 50\u003c\/p\u003e \u003cp\u003e2.4.3.1 Cell Seeding Density 51\u003c\/p\u003e \u003cp\u003e2.4.3.2 Microcarrier Concentrations (Cells:Bead Ratio) 52\u003c\/p\u003e \u003cp\u003e2.4.3.3 Operation Ranges of pH and Dissolved Oxygen 53\u003c\/p\u003e \u003cp\u003e2.4.3.4 Feeding Strategy 54\u003c\/p\u003e \u003cp\u003e2.4.4 Process Development in Medium-scale Bioreactors (50L) 55\u003c\/p\u003e \u003cp\u003e2.4.5 Case Study for Expansion of Bone Marrow Derived MSCs in Stirred Tank Bioreactors 59\u003c\/p\u003e \u003cp\u003e2.5 Future Directions 60\u003c\/p\u003e \u003cp\u003eReferences 61\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 The Effect of Scale-up on Cell Phenotype: Comparability Testing to Optimize Bioreactor Usage and Manufacturing Strategies 65\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eJason Hamilton and Bart Vaes\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 65\u003c\/p\u003e \u003cp\u003e3.1.1 Cell Characterization in the Development Path 66\u003c\/p\u003e \u003cp\u003e3.1.2 The MultiStem® Allogeneic Cell Therapy Product: Mechanisms of Benefit and Target Cells Numbers 69\u003c\/p\u003e \u003cp\u003e3.2 Challenges in Cell Product Development 72\u003c\/p\u003e \u003cp\u003e3.2.1 Effect of Large-scale Expansion on Stem Cell Properties 72\u003c\/p\u003e \u003cp\u003e3.2.2 Serum-free and Xeno-free Media Development 74\u003c\/p\u003e \u003cp\u003e3.3 Stem Cell Characterization 75\u003c\/p\u003e \u003cp\u003e3.3.1 ISCT Requirements 75\u003c\/p\u003e \u003cp\u003e3.3.2 Potency Assays 77\u003c\/p\u003e \u003cp\u003e3.3.3 Omics Screens for Therapeutic Stem Cell Characterization 78\u003c\/p\u003e \u003cp\u003e3.4 Next-generation Stem Cell Development 80\u003c\/p\u003e \u003cp\u003eReferences 83\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 The Scale-up of Human Mesenchymal Stem Cell Expansion and Recovery 91\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eThomas R. J. Heathman, Qasim A. Rafiq, Karen Coopman, Alvin W. Nienow and Christopher J. Hewitt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 91\u003c\/p\u003e \u003cp\u003e4.2 Scale-up or Scale-out 93\u003c\/p\u003e \u003cp\u003e4.3 Understanding the Small Scale 96\u003c\/p\u003e \u003cp\u003e4.4 Microcarrier Screening 103\u003c\/p\u003e \u003cp\u003e4.5 Spinner Flask Culture 108\u003c\/p\u003e \u003cp\u003e4.6 Large-scale Expansion in Conventional Stirred Tank Bioreactors 111\u003c\/p\u003e \u003cp\u003e4.7 Cell Recovery from Microcarriers 117\u003c\/p\u003e \u003cp\u003e4.8 Conclusions 120\u003c\/p\u003e \u003cp\u003eReferences 121\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Challenges of Scale-up of Cell Separation and Purification Techniques 127\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMarieke A. Hoeve, Paul A. De Sousa and Nicholas A. Willoughby\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 127\u003c\/p\u003e \u003cp\u003e5.1.1 Cell Separation for Cell-based Therapeutics 127\u003c\/p\u003e \u003cp\u003e5.1.2 Separation Methodology Design 128\u003c\/p\u003e \u003cp\u003e5.1.3 Objective of this Chapter 128\u003c\/p\u003e \u003cp\u003e5.1.3.1 Cell Yield 129\u003c\/p\u003e \u003cp\u003e5.1.3.2 Standardisation 129\u003c\/p\u003e \u003cp\u003e5.1.3.3 Economical viability 129\u003c\/p\u003e \u003cp\u003e5.2 Scalable Cell Separation for Cell Therapy 130\u003c\/p\u003e \u003cp\u003e5.2.1 Label Requiring versus Label-free Separation 130\u003c\/p\u003e \u003cp\u003e5.2.2 Active versus Passive Method 133\u003c\/p\u003e \u003cp\u003e5.2.3 Isolated Purification (Including Off-the-Shelf) versus Embedded Integrated Process 133\u003c\/p\u003e \u003cp\u003e5.2.4 Low versus High Resolution 133\u003c\/p\u003e \u003cp\u003e5.2.5 Open versus Closed Systems 134\u003c\/p\u003e \u003cp\u003e5.2.6 Batch versus Continuous Separation 134\u003c\/p\u003e \u003cp\u003e5.3 Currently Developed Cell Separation Techniques 135\u003c\/p\u003e \u003cp\u003e5.3.1 Acoustophoresis 135\u003c\/p\u003e \u003cp\u003e5.3.2 Aqueous Two-Phase System (ATPS) 137\u003c\/p\u003e \u003cp\u003e5.3.3 Centrifugal Techniques 138\u003c\/p\u003e \u003cp\u003e5.3.3.1 Centrifugal Counterflow Elutriation (CCE) 138\u003c\/p\u003e \u003cp\u003e5.3.3.2 Centrifuge Systems with Integrated Filters 139\u003c\/p\u003e \u003cp\u003e5.3.4 Dielectrophoresis (DEP) 140\u003c\/p\u003e \u003cp\u003e5.3.5 Deterministic Lateral Displacement (DLD) 141\u003c\/p\u003e \u003cp\u003e5.3.6 Genetic Engineering 141\u003c\/p\u003e \u003cp\u003e5.3.7 Hydrodynamic Filtration (HDF) 142\u003c\/p\u003e \u003cp\u003e5.3.8 Immunoadsorption 142\u003c\/p\u003e \u003cp\u003e5.3.9 Immunomagnetic Cell Sorting 145\u003c\/p\u003e \u003cp\u003e5.3.10 Inertial Migration 145\u003c\/p\u003e \u003cp\u003e5.3.11 Magnetic Cell Sorting – Label-free 147\u003c\/p\u003e \u003cp\u003e5.3.11.1 Magnetophoretic Cell Separation 147\u003c\/p\u003e \u003cp\u003e5.3.11.2 Magnetic Solution-based Separation 148\u003c\/p\u003e \u003cp\u003e5.3.12 Microscale Vortices 150\u003c\/p\u003e \u003cp\u003e5.3.13 Normal Flow Filter (NFF) 150\u003c\/p\u003e \u003cp\u003e5.3.14 Optical – Label-free 151\u003c\/p\u003e \u003cp\u003e5.3.15 Tangential Flow Filters (TFF) 155\u003c\/p\u003e \u003cp\u003e5.3.16 Weir and Pillar 156\u003c\/p\u003e \u003cp\u003e5.4 Conclusion 157\u003c\/p\u003e \u003cp\u003eAcknowledgements 159\u003c\/p\u003e \u003cp\u003eReferences 159\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Fundamental Points to Consider in the Cryopreservation and Shipment of Cells for Human Application 167\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eGlyn N. Stacey, Lyn Healy, Jennifer Man, Charles J. Hunt and John Morris\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 167\u003c\/p\u003e \u003cp\u003e6.2 The Role of Cryoprotective Agents (CPA) 168\u003c\/p\u003e \u003cp\u003e6.3 Vitrification versus Cryopreservation 169\u003c\/p\u003e \u003cp\u003e6.4 Points to Consider in the Development of Cryopreservation Protocols 169\u003c\/p\u003e \u003cp\u003e6.4.1 General Considerations 169\u003c\/p\u003e \u003cp\u003e6.4.2 Cellular Characteristics and Selection of Appropriate CPAs and Cooling Protocols 170\u003c\/p\u003e \u003cp\u003e6.4.3 Key Events in Cryopreservation 172\u003c\/p\u003e \u003cp\u003e6.4.3.1 Ice Nucleation 174\u003c\/p\u003e \u003cp\u003e6.4.3.2 CPAs: Concentration and Composition 174\u003c\/p\u003e \u003cp\u003e6.4.3.3 Cooling Rate 174\u003c\/p\u003e \u003cp\u003e6.4.3.4 Storage of Cryopreserved Cells 176\u003c\/p\u003e \u003cp\u003e6.4.3.5 Thawing and Recovery of Frozen Cells 177\u003c\/p\u003e \u003cp\u003e6.5 Large-volume Freezing 178\u003c\/p\u003e \u003cp\u003e6.6 Cryopreservation as Part of Manufacturing Processes 179\u003c\/p\u003e \u003cp\u003e6.6.1 Containers for Cryopreserved Cells 179\u003c\/p\u003e \u003cp\u003e6.6.2 Controlled Rate Freezers and Storage Systems 179\u003c\/p\u003e \u003cp\u003e6.6.3 The Cold-chain: Challenges and Solutions 180\u003c\/p\u003e \u003cp\u003e6.6.4 Biobanking and Regulatory Requirements 181\u003c\/p\u003e \u003cp\u003e6.7 Conclusions 181\u003c\/p\u003e \u003cp\u003eAcknowledgements 182\u003c\/p\u003e \u003cp\u003eReferences 182\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Short-term Storage of Cells for Application in Cell-based Therapies 187\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eStephen Swioklo and Che J. Connon\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 187\u003c\/p\u003e \u003cp\u003e7.1.1 Advances in Cell-based Therapies 188\u003c\/p\u003e \u003cp\u003e7.1.2 The Logistical Landscape for CTPs and the Requirement for Short-term Storage of Cells 188\u003c\/p\u003e \u003cp\u003e7.2 Hypothermia and Mammalian Cell Storage 193\u003c\/p\u003e \u003cp\u003e7.2.1 Hypothermic Storage of Mesenchymal Stem Cells (MSCs) 194\u003c\/p\u003e \u003cp\u003e7.2.2 Optimal Temperature for Cell Storage 202\u003c\/p\u003e \u003cp\u003e7.3 The Application of Hypothermic Storage in Cell-based Therapies 204\u003c\/p\u003e \u003cp\u003e7.4 Concluding Remarks 205\u003c\/p\u003e \u003cp\u003eReferences 205\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Cell Therapy in Practice 211\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eGustavo S. Figueiredo, Julian R. De Havilland, Majlinda Lako and Francisco C. Figueiredo\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 211\u003c\/p\u003e \u003cp\u003e8.2 The Classification of ATMPs 212\u003c\/p\u003e \u003cp\u003e8.3 European Regulations 216\u003c\/p\u003e \u003cp\u003e8.3.1 Hospital Exemption (HE) and “Specials” Manufacturing 219\u003c\/p\u003e \u003cp\u003e8.3.2 Orphan Medicinal Product Designation 220\u003c\/p\u003e \u003cp\u003e8.3.3 Committee for Advanced Therapies 221\u003c\/p\u003e \u003cp\u003e8.3.4 Good Manufacturing Practice (GMP) 221\u003c\/p\u003e \u003cp\u003e8.3.5 European Union Tissue and Cells Directives (EUTCD) 223\u003c\/p\u003e \u003cp\u003e8.4 ATMP Case Study: Autologous Limbal Stem Cell Therapy: the Newcastle Experience 224\u003c\/p\u003e \u003cp\u003e8.5 Conclusion 233\u003c\/p\u003e \u003cp\u003eReferences 234\u003c\/p\u003e \u003cp\u003eIndex 237\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":49528836325719,"sku":"9781118743416","price":113.36,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781118743416.jpg?v=1731873212","url":"https:\/\/bookcurl.com\/products\/bioprocessing-for-cellbased-therapies-9781118743416","provider":"Book Curl","version":"1.0","type":"link"}