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Title Biopharmaceutical processing : development, design, and implementation of manufacturing processes / edited by Günter Jagschies, Eva Lindskog, Karol Ła̧cki, Parrish Galliher
Published Amsterdam, Netherlands : Elsevier, [2018]

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Description 1 online resource (xxxi, 1275 pages) : illustrations, map
Contents Section I : Healthcare and Biopharma Industry, Products and Processes -- Disease and Healthcare Priorities / Günter Jagschies -- Brief Review of the Biopharmaceutical and Vaccine Industry / Günter Jagschies -- Selected Biotherapeutics Overview / Günter Jagschies -- Process Capability Requirements / Günter Jagschies, Karol M. Ła̧cki -- Section II : Upstream Processes Principles and Methods -- Upstream Bioprocessing : Basic Concepts / Eva K. Lindskog -- Host Cells / Eva K. Lindskog, Simon Fischer, Till Wenger, Patrick Schulz -- Cell Line Development / Andreas Castan, Patrick Schulz, Till Wenger, Simon Fischer -- Cell Culture Media in Bioprocessing / William G. Whitford, Mats Lundgren, Alain Fairbank -- Section III : Recovery Processes, Principles, and Methods -- Industry Review of Cell Separation and Product Harvesting Methods / John P. Pieracci, John W. Armando, Matthew Westoby, Jorg Thommes -- Overview of Alternative Separation Methods in Relation to Process Challenges / James M. Van Alstine, Günter Jagschies, Karol M. Ła̧cki -- Alternative Separation Methods : Flocculation and Precipitation / James M. Van Alstine, Günter Jagschies, Karol M. Ła̧cki -- Alternative Separation Methods : Crystallization and Aqueous Polymer Two-Phase Extraction / James M. Van Alstine, Günter Jagschies, Karol M. Ła̧cki -- Expanded Bed Adsorption / Kine A.K. Frej, Rolf A. Hjorth -- Filtration Principles / Jakob Liderfelt, Jonathan Royce -- Filtration Methods for Use in Recovery Processes / Jonathan Royce, Jakob Liderfelt, Craig Robinson -- Section IV : Purification Processes, Principles and Methods -- Introduction to Preparative Protein Chromatography / Karol M. Ła̧cki -- Affinity Chromatography / Åke Daniellson -- Ion Exchange Chromatography / Anna Grönberg -- Hydrophobic Interaction Chromatography / Kjell O. Eriksson -- Multimodal Chromatography / Effert Brekkan -- Size Exclusion Chromatography (SEC) / Martin Hall -- Reversed Phase Chromatography / Kjell O. Eriksson -- Filtration Methods for Use in Purification Processes (Concentration and Buffer Exchange) / Jakob Liderfelt, Jonathan Royce -- Section V : Bioprocessing Equipment -- Upstream Processing Equipment / Kenneth P. Clapp, Andreas Castan, Eva K. Lindskog -- Downstream Processing Equipment / Mikael I. Johansson, Martin Östling, Günter Jagschies -- Chromatography Columns / Klaus Gebauer, Johan Tschöp -- Simplification of Buffer Formulation and Improvement of Buffer Control with In-Line Conditioning (IC) / Enrique N. Carredano, Roger Nordberg, Susanne Westin, Karolina Busson, Tomas M. Karlsson, Torbjörn S. Blank, Henrik Sandegren, Günter Jagschies -- Continuous Capture of mAbs--Points to Consider and Case Studies / Günter Jagschies -- Single Use Technology and Equipment / Parrish M. Galliher -- Process Control and Automation Solutions / Trevor J. Marshall, Yvonne A. Brady -- Section VI : Industrial process design -- The Upstream Process : Principal Modes of Operation / Eva K. Lindskog -- Downstream Process Design, Scale-Up Principles, and Process Modeling / Karol M. Ła̧cki, John Joseph, Kjell O. Eriksson -- Cleaning-in-Place and Sanitization / Anna Grönberg, Rolf A. Hjorth -- The Search for Process Intensification and Simplification : Alternative Approaches versus Current Platform Processe / Robert S. Gronke, Alan Gilbert -- Single-Use Technology Implementation For Biologics and Vaccines Production / David J. Pollard, Alain Pralong -- Points to Consider for Design and Control of Continuous Bioprocessing / Oliver Kaltenbrunner -- Perfusion N-1 Culture--Opportunities for Process Intensification / John M. Woodgate -- Process Development and Intensification for a Recombinant Protein Expressed in E.coli / Shuang Chen, William B. Wellborn, John T. Cundy, Ratish Mangalath-Illam, Scott A. Cook, Matthew J. Stork, Joseph P. Martin, Maire H. Caparon, Stephen E. Sobacke, Sriram Srinivasan, Joost P. Quaadgras -- Next-Generation Process Design for Monoclonal Antibody Purification / Krunal K. Mehta, Ganesh Vedantham -- Process Development and Manufacturing of Antibody-Drug Conjugates / Matt H. Hutchinson, Rachel S. Hendricks, Xin Xin Lin, Dana A Olsson -- Process Design for Bispecific Antibodies / Ambrose J. Williams, Glen S. Giese, Andreas Shaubmar, Thomas von Hirschheydt -- Current Manufacturing of Human Plasma Immunoglobulin G / Andrea Buchacher, John M. Curling -- Modern Production Strategies in the Vaccine Industry / Hari Pujar, Mats Lundgren -- Bioprocesses for Cell Therapies / Suzanne S. Farid, Michael J. Jenkins -- Section VII : Facility Design and Operation -- Facility Design and Process Utilities / John Joseph -- Points to Consider in Manufacturing Operations / Geoff Hodge -- Section VIII : Analytics, Regulatory, Quality, and Safety Aspects -- Analytical Methods / Matthew J. Traylor, Peter Bernhardt, Bruce S. Tangarone, Johnson Varghese -- Implementation of QbD for Manufacturing of Biologics--Has It Met the Expectations? / Anurag S. Rathore, Sumit K. Singh, Jashwant Kumar, Gautum Kapoor -- Pathogen Safety / Albrecht Gröner -- Chemistry, Manufacture and Control / Kim R. Hejnaes, Tom C. Ransohoff -- Post-Licensure Purification Process Improvements for Therapeutic Antibodies : Current and Future States / Brian D. Kelley, Annika Kleinjans, Philip Lester -- Navigating the Regulatory Maze Upon Process Changes / E. Morrey Atkinson, Michael A. Rubacha -- Security of Bioprocess Consumables Supply / Jeffrey R. Carter, Daniel Nelson, David G. Westman -- Section IX : Financial Management and Process Economics -- Basics of Financial Management / Brian Montgomery -- Management of Process Economy--Case Studies / Günter Jagschies -- Section X : Appendices -- Appendix 1. The Ideal-World Research Portfolio -- Appendix 2. History of Biomedical Research -- Appendix 3. Marketed Biotherapeutics
Summary Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry
Bibliography Includes bibliographical references and index
Notes Vendor-supplied metadata
Subject Biopharmaceutics.
Drugs -- Design.
Biopharmaceutics
Drug Design
MEDICAL -- Pharmacology.
Drugs -- Design
Biopharmaceutics
Form Electronic book
Author Jagschies, Günter, editor.
Lindskog, Eva, editor.
Łącki, Karol, editor.
Galliher, Parrish, editor.
ISBN 9780128125526
0128125527