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Biopharmaceutical processing : development, design, and implementation of manufacturing processes /
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...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , , , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Amsterdam, Netherlands :
Elsevier,
[2018]
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Section I : Healthcare and Biopharma Industry, Products and Processes
- Disease and Healthcare Priorities / G�unter Jagschies
- Brief Review of the Biopharmaceutical and Vaccine Industry / G�unter Jagschies
- Selected Biotherapeutics Overview / G�unter Jagschies
- Process Capability Requirements / G�unter Jagschies, Karol M. ��acki
- 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, G�unter Jagschies, Karol M. ��acki
- Alternative Separation Methods : Flocculation and Precipitation / James M. Van Alstine, G�unter Jagschies, Karol M. ��acki
- Alternative Separation Methods : Crystallization and Aqueous Polymer Two-Phase Extraction / James M. Van Alstine, G�unter Jagschies, Karol M. ��acki
- 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. ��acki
- Affinity Chromatography / �ke Daniellson
- Ion Exchange Chromatography / Anna G�rnberg
- 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 �stling, G�unter Jagschies
- Chromatography Columns / Klaus Gebauer, Johan Tsc�hp
- 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, Torb�jrn S. Blank, Henrik Sandegren, G�unter Jagschies
- Continuous Capture of mAbs--Points to Consider and Case Studies / G�unter 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. ��acki, John Joseph, Kjell O. Eriksson
- Cleaning-in-Place and Sanitization / Anna G�rnberg, 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 G�rner
- 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 / G�unter Jagschies
- Section X : Appendices
- Appendix 1. The Ideal-World Research Portfolio
- Appendix 2. History of Biomedical Research
- Appendix 3. Marketed Biotherapeutics.