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Informationen zum Autor Uwe Gottschalk, PhD, is Chief Technology Officer at Lonza Pharma/Biotech, Switzerland. Previously, he served as Group Vice President at Sartorius Stedim Biotech (2004-2014) and in various development and manufacturing capacities at Bayer Health Care (1991-2004). Dr. Gottschalk received a doctorate in chemistry from the University of Münster (Germany) for work on antibody-drug conjugates at the Cancer Research Campaign Laboratories in Nottingham (UK). He is Head Lecturer at the University of Duisburg-Essen, Germany, and has written extensively in the areas of industrial biotechnology and somatic gene therapy. Klappentext Stay on the cutting edge of antibody purification with the insights of industry experts Biopharmaceutical companies are under extreme pressure to develop robust and economical large-scale processes while consistently meeting regulatory standards for safety and purity. Unfortunately, while upstream productivity has increased in line with demand, downstream processing is mired in a technology crisis resulting in production bottlenecks. Antibody purification is sandwiched between fermentation and drug formulation, two areas that have traditionally received the lion's share of industry awareness as well as generous research funding and attention in the literature. As a result, improvements in purification technology are needed urgently to meet the challenges of increasing demands without sacrificing product quality. The second edition of Process Scale Purification of Antibodies continues the legacy of its predecessor to offer scientists, researchers, and engineers an essential resource focused on best practices in manufacturing antibody drugs. It covers different antibody purification strategies, including new developments since the publication of the first edition, and an assembly of top-tier experts in these disparate technologies with the common aim of addressing problems in process-scale antibody purification. Recognized for providing a fresh perspective on traditional chromatography as well as alternative technologies and unit operations, the first edition covered innovative developments in protein purification like smart membranes, bioaffinity mimetics as well as orthogonal, and integrated strategies. The revision updates these topics and also introduces platform concepts that have gained traction over the ensuing years--including the purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing. Process Scale Purification of Antibodies, therefore, consolidates the unique niche occupied by its predecessor and maintains interest in this neglected subject area by promoting the continued, much-needed renaissance in antibody purification.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. Inhaltsverzeichnis Preface xxiii List of Contributors xxvii 1 Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities 1 Brian Kelley 1.1 Introduction 1 1.2 A Brief History of Current Good Manufacturing Process mAb and Intravenous Immunoglobulin Purification 2 1.3 Current Approaches in Purification Process Development: Impact of Platform Processes 4 1.4 Typical Unit Operations and Processing Alternatives 7 1.5 VLS Processes: Ton¿Scale Production and Beyond 10 1.6 Process Validation 12 1.7 Product Life Cycle Management 13 1.8 Future Opportunities 16 1.9 Conclusions 18 Acknowledgments 19 References 19 2 The Development of Antibody Purification Technologies 23 John Curli...
