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Process Scale Purification of Antibodies, 2ed

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.

• 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

About the Author

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 (1991–۲۰۰۴). 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.

۱ Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities
۲ The Development of Antibody Purification Technologies
۳ Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification
۴ Next‐Generation Clarification Technologies for the Downstream
۵ Protein A‐Based Affinity Chromatography
۶ Purification of Human Monoclonal Antibodies: Non‐Protein A Strategies
۷ Hydrophobic Interaction Chromatography for the Purification of Antibodies
۸ Purification of Monoclonal Antibodies by Mixed‐Mode Chromatography
۹ Advances in Technology and Process Development for Industrial‐Scale Monoclonal Antibody Purification
۱۰ Alternatives to Packed‐Bed Chromatography for Antibody Extraction and Purification
۱۱ Process‐Scale Precipitation of Impurities in Mammalian Cell Culture Broth
۱۲ Charged Ultrafiltration and Microfiltration Membranes for Antibody Purification
۱۳ Disposable Prepacked‐Bed Chromatography for Downstream Purification: Form, Fit, Function, and Industry Adoption
۱۴ Integrated Polishing Steps for Monoclonal Antibody Purification
۱۵ Orthogonal Virus Clearance Applications in Monoclonal Antibody Production
۱۶ Development of a Platform Process for the Purification of Therapeutic Monoclonal Antibodies
۱۷ The Evolution of Platform Technologies for the Downstream Processing of Antibodies
۱۸ Countercurrent Chromatography for the Purification of Monoclonal Antibodies, Bispecific Antibodies, and Antibody–Drug Conjugates
۱۹ The Evolution of Continuous Chromatography:
۲۰ Accelerated Seamless Antibody Purification: Simplicity is Key
۲۱ Process Economic Drivers in Industrial Monoclonal Antibody Manufacture
۲۲ Design and Optimization of Manufacturing
۲۳ Smart Design for an Efficient Facility With a Validated Disposable System
۲۴ High‐Throughput Screening and Modeling Technologies for Process Development in Antibody Purification 515
۲۵ Downstream Processing of Monoclonal Antibody Fragments
۲۶ Downstream Processing of Fc Fusion Proteins, Bispecific Antibodies, and Antibody–Drug Conjugates 559
۲۷ Manufacturing Concepts for Antibody–Drug Conjugates
۲۸ Purification of IgM and IgA
۲۹ Purification of Monoclonal Antibodies From Plants
۳۰ Very‐Large‐Scale Production of Monoclonal Antibodies in Plants
۳۱ Trends in Formulation and Drug Delivery for Antibodies
۳۲ Antibody Purification: Drivers of Change

قیمت : 3500 تومان

لینک کوتاه : https://bookbaz.ir/?p=56538
نویسنده : Uwe Gottschalk
ناشر : Wiley; 2 edition
سال انتشار : 2017
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 728
(ISBN) شابک : 1119126916
قیمت کتاب درآمازون : $204.94
حجم فایل : 10 MB

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Process Scale Purification of Antibodies, 2ed