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Process scale purification of antibodies / / edited by Uwe Gottschalk
| Process scale purification of antibodies / / edited by Uwe Gottschalk |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2017 |
| Descrizione fisica | 1 online resource (754 pages) : illustrations |
| Disciplina | 616.0798072 |
| Soggetto topico |
Monoclonal antibodies
Monoclonal antibodies - Purification |
| ISBN |
1-119-12693-2
1-119-12694-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910270897503321 |
| Hoboken, New Jersey : , : Wiley, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Process scale purification of antibodies / / edited by Uwe Gottschalk
| Process scale purification of antibodies / / edited by Uwe Gottschalk |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2017 |
| Descrizione fisica | 1 online resource (754 pages) : illustrations |
| Disciplina | 616.0798072 |
| Soggetto topico |
Monoclonal antibodies
Monoclonal antibodies - Purification |
| ISBN |
1-119-12693-2
1-119-12694-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910826993203321 |
| Hoboken, New Jersey : , : Wiley, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Process scale purification of antibodies [[electronic resource] /] / edited by Uwe Gottschalk
| Process scale purification of antibodies [[electronic resource] /] / edited by Uwe Gottschalk |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2009 |
| Descrizione fisica | 1 online resource (458 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | GottschalkUwe |
| Soggetto topico |
Monoclonal antibodies - Purification
Biochemical engineering |
| ISBN |
1-118-21074-3
1-282-00919-2 9786612009198 0-470-44489-4 0-470-44488-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
PROCESS SCALE PURIFICATION OF ANTIBODIES; CONTENTS; Preface; About the Author; Contributors; 1 Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities; 1.1 Introduction; 1.2 A Brief History of cGMP mAb and Intravenous Immunoglobulin (IgIV) Purification; 1.3 Current Approaches in Purification Process Development: Impact of Platform Processes; 1.4 Typical Unit Operations and Processing Alternatives; 1.5 VLS Processes: Ton-Scale Production and Beyond; 1.6 Process Validation; 1.7 Product Life Cycle Management; 1.8 Future Opportunities; 1.9 Conclusions
1.10 Acknowledgments1.11 References; 2 The Development of Antibody Purification Technologies; 2.1 Introduction; 2.2 Chromatographic Purification of Antibodies before Protein A; 2.3 Antibody Purification after 1975; 2.4 Additional Technologies for Antibody Purification; 2.5 Purification of mAbS Approved in North America and in Europe; 2.6 Acknowledgments; 2.7 References; 3 Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification; 3.1 Introduction; 3.2 Centrifugation; 3.3 Microfiltration; 3.4 Depth Filtration; 3.5 Flocculation; 3.6 Absolute Filtration 3.7 Expanded-Bed Chromatography3.8 Comparison of Harvest and Clarification Unit Operations; 3.9 Acknowledgments; 3.10 References; 4 Protein A-Based Affinity Chromatography; 4.1 Introduction; 4.2 Properties of Protein A and Commercially Available Protein A Resins; 4.2.1 Protein A Structure; 4.2.2 Protein A-Immunoglobulin G (IgG) Interaction; 4.2.3 Stoichiometry of Protein A-IgG Binding; 4.2.4 Protein A Stability; 4.2.5 Commercial Protein A Resins; 4.2.6 Static Capacity; 4.2.7 DBC; 4.2.8 Leaching; 4.2.9 Production Rates; 4.3 Protein A Chromatography Step Development; 4.3.1 Loading/Binding 4.3.2 Wash Development4.3.3 Elution; 4.3.4 Stripping; 4.3.5 Regeneration and CIP; 4.4 Additional Considerations During Development and Scale-Up; 4.4.1 Controlling HMW Formation; 4.4.2 Removal of Soluble HMW Contaminants; 4.4.3 Turbidity; 4.5 Virus Removal/Inactivation; 4.5.1 Virus Removal; 4.5.2 Low-pH Inactivation; 4.5.3 Bovine/Transmissible Spongiform Encephalopathy (BSE/TSE) Clearance; 4.6 Validation and Robustness; 4.6.1 Validation; 4.6.2 Robustness; 4.7 Conclusions; 4.8 Acknowledgments; 4.9 References; 5 Purification of Human Monoclonal Antibodies: Non-Protein A Strategies 5.1 Introduction5.2 Integrated Process Designs for Human Monoclonal Antibody (HuMab) Production; 5.3 Purification Process Designs for HuMabs; 5.3.1 Protein A Purification Schemes; 5.3.2 Non-Protein A Purification Schemes; 5.3.3 Host Cell Protein (HCP) Exclusion Approach for Ion-Exchange Purification Schemes; 5.4 Conclusions; 5.5 Acknowledgments; 5.6 References; 6 Purification of Monoclonal Antibodies by Mixed-Mode Chromatography; 6.1 Introduction; 6.2 A Brief History; 6.3 Prerequisites for Industrial Implementation; 6.4 Mechanisms, Screening, and Method Development; 6.5 Capture Applications 6.6 Polishing Applications |
| Record Nr. | UNINA-9910782895903321 |
| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Process scale purification of antibodies [[electronic resource] /] / edited by Uwe Gottschalk
| Process scale purification of antibodies [[electronic resource] /] / edited by Uwe Gottschalk |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2009 |
| Descrizione fisica | 1 online resource (458 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | GottschalkUwe |
| Soggetto topico |
Monoclonal antibodies - Purification
Biochemical engineering |
| ISBN |
1-118-21074-3
1-282-00919-2 9786612009198 0-470-44489-4 0-470-44488-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
PROCESS SCALE PURIFICATION OF ANTIBODIES; CONTENTS; Preface; About the Author; Contributors; 1 Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities; 1.1 Introduction; 1.2 A Brief History of cGMP mAb and Intravenous Immunoglobulin (IgIV) Purification; 1.3 Current Approaches in Purification Process Development: Impact of Platform Processes; 1.4 Typical Unit Operations and Processing Alternatives; 1.5 VLS Processes: Ton-Scale Production and Beyond; 1.6 Process Validation; 1.7 Product Life Cycle Management; 1.8 Future Opportunities; 1.9 Conclusions
1.10 Acknowledgments1.11 References; 2 The Development of Antibody Purification Technologies; 2.1 Introduction; 2.2 Chromatographic Purification of Antibodies before Protein A; 2.3 Antibody Purification after 1975; 2.4 Additional Technologies for Antibody Purification; 2.5 Purification of mAbS Approved in North America and in Europe; 2.6 Acknowledgments; 2.7 References; 3 Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification; 3.1 Introduction; 3.2 Centrifugation; 3.3 Microfiltration; 3.4 Depth Filtration; 3.5 Flocculation; 3.6 Absolute Filtration 3.7 Expanded-Bed Chromatography3.8 Comparison of Harvest and Clarification Unit Operations; 3.9 Acknowledgments; 3.10 References; 4 Protein A-Based Affinity Chromatography; 4.1 Introduction; 4.2 Properties of Protein A and Commercially Available Protein A Resins; 4.2.1 Protein A Structure; 4.2.2 Protein A-Immunoglobulin G (IgG) Interaction; 4.2.3 Stoichiometry of Protein A-IgG Binding; 4.2.4 Protein A Stability; 4.2.5 Commercial Protein A Resins; 4.2.6 Static Capacity; 4.2.7 DBC; 4.2.8 Leaching; 4.2.9 Production Rates; 4.3 Protein A Chromatography Step Development; 4.3.1 Loading/Binding 4.3.2 Wash Development4.3.3 Elution; 4.3.4 Stripping; 4.3.5 Regeneration and CIP; 4.4 Additional Considerations During Development and Scale-Up; 4.4.1 Controlling HMW Formation; 4.4.2 Removal of Soluble HMW Contaminants; 4.4.3 Turbidity; 4.5 Virus Removal/Inactivation; 4.5.1 Virus Removal; 4.5.2 Low-pH Inactivation; 4.5.3 Bovine/Transmissible Spongiform Encephalopathy (BSE/TSE) Clearance; 4.6 Validation and Robustness; 4.6.1 Validation; 4.6.2 Robustness; 4.7 Conclusions; 4.8 Acknowledgments; 4.9 References; 5 Purification of Human Monoclonal Antibodies: Non-Protein A Strategies 5.1 Introduction5.2 Integrated Process Designs for Human Monoclonal Antibody (HuMab) Production; 5.3 Purification Process Designs for HuMabs; 5.3.1 Protein A Purification Schemes; 5.3.2 Non-Protein A Purification Schemes; 5.3.3 Host Cell Protein (HCP) Exclusion Approach for Ion-Exchange Purification Schemes; 5.4 Conclusions; 5.5 Acknowledgments; 5.6 References; 6 Purification of Monoclonal Antibodies by Mixed-Mode Chromatography; 6.1 Introduction; 6.2 A Brief History; 6.3 Prerequisites for Industrial Implementation; 6.4 Mechanisms, Screening, and Method Development; 6.5 Capture Applications 6.6 Polishing Applications |
| Record Nr. | UNINA-9910819255503321 |
| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
