LEADER 05375nam 22006614a 450 001 9910819255503321 005 20240418145801.0 010 $a1-118-21074-3 010 $a1-282-00919-2 010 $a9786612009198 010 $a0-470-44489-4 010 $a0-470-44488-6 035 $a(CKB)1000000000715865 035 $a(EBL)416189 035 $a(OCoLC)476247204 035 $a(SSID)ssj0000228184 035 $a(PQKBManifestationID)11196278 035 $a(PQKBTitleCode)TC0000228184 035 $a(PQKBWorkID)10149079 035 $a(PQKB)10257855 035 $a(MiAaPQ)EBC416189 035 $a(Au-PeEL)EBL416189 035 $a(CaPaEBR)ebr10297679 035 $a(CaONFJC)MIL200919 035 $a(EXLCZ)991000000000715865 100 $a20080902d2009 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aProcess scale purification of antibodies$b[electronic resource] /$fedited by Uwe Gottschalk 205 $a1st ed. 210 $aHoboken, N.J. $cJohn Wiley & Sons$dc2009 215 $a1 online resource (458 p.) 300 $aErrata slip inserted. 311 $a0-470-20962-3 320 $aIncludes bibliographical references and index. 327 $aPROCESS 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 327 $a1.10 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 327 $a3.7 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 327 $a4.3.2 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 327 $a5.1 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 327 $a6.6 Polishing Applications 330 $aTraditional column chromatography dominates current purification technology, and many of the productivity gains that have been achieved have relied on upscaling such devices. However, this comes with a cost penalty and the pharmaceutical industry has reached the point at which further upscaling becomes economically unsupportable. This book offers a broad-based reassessment of old and new purification methods, incorporating an analysis of innovative new trends in purification. The book has wide coverage of different antibody purification strategies and brings together top-tier experts to addres 606 $aMonoclonal antibodies$xPurification 606 $aBiochemical engineering 615 0$aMonoclonal antibodies$xPurification. 615 0$aBiochemical engineering. 676 $a615/.19 701 $aGottschalk$b Uwe$01603210 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910819255503321 996 $aProcess scale purification of antibodies$93927489 997 $aUNINA