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Process scale purification of antibodies

Author: Uwe Gottschalk
Publisher: Hoboken, NJ : Wiley, 2017.
Edition/Format:   eBook : Document : English : Second editionView all editions and formats
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Promoting 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  Read more...

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Genre/Form: Electronic books
Additional Physical Format: Print version:
Process scale purification of antibodies.
Hoboken, NJ : John Wiley & Sons Inc., 2017
(DLC) 2017005408
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Uwe Gottschalk
ISBN: 9781119126928 1119126924 9781119126935 1119126932 9781119126942 1119126940
OCLC Number: 972640364
Description: 1 online resource
Contents: TITLE PAGE ; COPYRIGHT PAGE ; CONTENTS; PREFACE ; LIST OF CONTRIBUTORS; CHAPTER 1 DOWNSTREAM PROCESSING OF MONOCLONAL ANTIBODIES: CURRENT PRACTICES AND FUTURE OPPORTUNITIES; 1.1 INTRODUCTION; 1.2 A BRIEF HISTORY OF CURRENT GOOD MANUFACTURING PROCESS mAb AND INTRAVENOUS IMMUNOGLOBULIN 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. ACKNOWLEDGMENTSREFERENCES; CHAPTER 2 THE DEVELOPMENT OF ANTIBODY PURIFICATION TECHNOLOGIES; 2.1 INTRODUCTION; 2.2 PURIFICATION OF ANTIBODIES BY CHROMATOGRAPHY 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 EUROPE; 2.6 CURRENT ANTIBODY PROCESS TECHNOLOGY DEVELOPMENTS; ACKNOWLEDGMENTS; REFERENCES; CHAPTER 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 FLOCCULATION3.6 ABSOLUTE FILTRATION; 3.7 EXPANDED BED ADSORPTION CHROMATOGRAPHY; 3.8 HARVESTING IN SINGLE?USE MANUFACTURING; 3.9 COMPARISON OF HARVEST AND CLARIFICATION UNIT OPERATIONS; REFERENCES; CHAPTER 4 NEXT-GENERATION CLARIFICATION TECHNOLOGIES FOR THE DOWNSTREAM PROCESSING OF ANTIBODIES ; 4.1 INTRODUCTION; 4.2 IMPURITY PROFILES IN CELL CULTURES; 4.3 PRECIPITATION; 4.3.1 Acid Precipitation; 4.3.2 Caprylic Acid Precipitation; 4.3.3 PEG Precipitation; 4.3.4 Cold Ethanol Precipitation; 4.4 AFFINITY PRECIPITATION; 4.5 FLOCCULATION; 4.5.1 Anionic Flocculation; 4.5.2 Cationic Flocculation. 4.5.3 Multimodal Flocculation4.6 TOXICITY OF FLOCCULANTS AND PRECIPITANTS AND THEIR RESIDUAL CLEARANCE; 4.7 DEPTH FILTRATION; 4.7.1 Improvements in Depth Filtration Technology; 4.7.2 Impurity Removal by Depth Filtration; 4.7.3 Virus Clearance by Depth Filtration; 4.8 CONSIDERATIONS FOR THE IMPLEMENTATION OF NEW CLARIFICATION TECHNOLOGIES; 4.9 CONCLUSIONS AND FUTURE PERSPECTIVES; ACKNOWLEDGMENTS; REFERENCES; CHAPTER 5 PROTEIN A-BASED AFFINITY CHROMATOGRAPHY ; 5.1 INTRODUCTION; 5.2 PROPERTIES OF PROTEIN A AND COMMERCIALLY AVAILABLE PROTEIN A RESINS; 5.2.1 Protein A Structure. 5.2.2 Protein A-Immunoglobulin G Interaction5.2.3 Stoichiometry of Protein A-IgG Binding; 5.2.4 Protein A Stability; 5.2.5 Commercial Protein A Resins; 5.2.6 Static Capacity; 5.2.7 Dynamic Binding Capacity; 5.2.8 Leaching; 5.2.9 Production Rates; 5.3 PROTEIN A CHROMATOGRAPHY STEP DEVELOPMENT; 5.3.1 Loading/Binding; 5.3.2 Wash Development; 5.3.3 Elution; 5.3.4 Stripping; 5.3.5 Regeneration and CIP; 5.4 ADDITIONAL CONSIDERATIONS DURING DEVELOPMENT AND SCALE?UP; 5.4.1 Controlling HMW Aggregate Formation; 5.4.2 Removal of Soluble HMW Contaminants; 5.4.3 Turbidity; 5.5 VIRUS REMOVAL/INACTIVATION.
Responsibility: edited by Uwe Gottschalk.

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