Process scale purification of antibodies

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Title:

Author:

Gottschalk, Uwe, editor.

ISBN:

9781119126928

9781119126935

9781119126942

Edition:

Second edition.

Physical 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.

Abstract:

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 antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing.

Local Note:

John Wiley and Sons

Subject Term:

Monoclonal antibodies -- Purification.

Biochemical engineering.

Antibodies, Monoclonal -- isolation & purification

Antibodies, Monoclonal -- therapeutic use

Chromatography -- methods

Technology, Pharmaceutical -- methods

Génie biochimique.

MEDICAL -- Pharmacology.

Biochemical engineering