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Downstream Industrial Biotechnology
Recovery and Purification
Michael C. Flickinger (Edited by), MC Flickinger (Author)
9781118131244, Wiley
Hardback, published 5 April 2013
880 pages
28.7 x 22.1 x 5.1 cm, 2.268 kg
“The reference should be valuable to industry professionals as well as to advanced students of biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology.” (Chemical Engineering Progress, 1 August 2013)
DOWNSTREAM INDUSTRIAL BIOTECHNOLOGY An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley’s Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries.
Preface ix Contributors xi PART I INTRODUCTION 1 1 Bioprocess Design, Computer-Aided 5 PART II DOWNSTREAM RECOVERY OF CELLS AND PROTEIN CAPTURE 25 2 Cell Separation, Centrifugation 27 3 Cell Disruption, Micromechanical Properties 49 4 Cell Separation, Yeast Flocculation 65 5 Cell Wall Disruption and Lysis 81 6 Expanded Bed Chromatography, Surface Energetics of Biomass Deposition 95 7 Filter Aids 107 8 Protein Adsorption, Expanded Bed 115 PART III PROCESS DEVELOPMENT IN DOWNSTREAM PURIFICATION 127 9 Scaledown of Biopharmaceutical Purification Operations 129 10 Adsorption in Simulated Moving Beds (SMB) 147 11 Adsorption of Proteins with Synthetic Materials 179 12 Affinity Fusions for Protein Purification 191 13 Bioseparation, Magnetic Particle Adsorbents 201 14 High Throughput Technologies in Bioprocess Development 221 15 Large-Scale Protein Purification, Self-Cleaving Aggregation Tags 257 16 Lipopolysaccharide, LPS removal, Depyrogenation 269 17 Porous Media in Biotechnology 277 18 Protein Aggregation and Precipitation, Measurement and Control 293 PART IV EQUIPMENT DESIGN FOR DOWNSTREAM RECOVERY AND PROTEIN PURIFICATION 325 19 Cleaning and Sanitation in Downstream Processes 327 20 Clean-in-place 343 21 Large Scale Chromatography Columns, Modeling Flow Distribution 353 22 Pumps, Industrial 373 PART V DOWNSTREAM cGMP OPERATIONS 389 23 Affinity Chromatography of Plasma Proteins 391 24 Antibody Purification, Monoclonal and Polyclonal 405 25 Chromatographic Purification of Virus Particles 415 26 Chromatography, Hydrophobic Interactions 437 27 Chromatography, Radar Flow 449 28 Drying, Biological Materials 465 29 Freeze-Drying, Pharmaceuticals 485 30 Freezing, Biopharmaceutical 505 31 Membrane Chromatography 521 32 Membrane Separations 545 33 Plasmid Purification 557 34 Protein Chromatography, Manufacturing Scale 571 35 Protein Crystallization, Kinetics 579 36 Protein Purification, Aqueous Liquid Extraction 603 37 Protein Ultrafiltration 617 38 Virus Retentive Filters 641 PART VI BIOPHARMACEUTICAL FACILITY VALIDATION 655 39 Biopharmaceutical Facility Design and Validation 657 40 Closed Systems in Bioprocessing 677 41 Facility Design for Single Use (SU) Downstream Materials 685 42 eGMPs for Production Rooms 715 43 Heating, Ventilation, and Air Conditioning 731 44 Sterilization-in-Place (SIP) 747 PART VII FDA cGMP REGULATORY COMPLIANCE 757 45 Pharmaceutical Bioburden Testing 759 46 Chromatography, Industrial Scale Validation 775 47 GMPs and GLSPs 795 48 Quality by Design (QBD) 815 49 Regulatory Requirements, European Community 829 Index 843
Victor Papavasileiou, Charles Siletti, Alexandros Koulouris, and Demetri Petrides
Hans Axelsson
Ingo Kampen and Arno Kwade
Eduardo V. Soares
F. A. P. Garcia
Marcelo Fernandez Lahore, Oscar Aguilar, Rami Reddy Vennapusa and Muhammad Aasin
Tony Hunt
Siddartha Ghose
Anurag S. Rathore and Varsha S. Joshi
Cesar C. Santana, Ivanildo J. Silva Jr., Diana C. S. Azevedo, and Amaro G. Barreto Jr.
Joseph McGuire and Omkar Joshi
Susanne Gräslund and Martin Hammarström
Urs Alexander Peuker, Owen Thomas, Timothy John Hobley, Mathias Franzreb, Sonja Berensmeier, Maria Shäfer, and Birgit Hickstein
Trent Carrier, Eva Heldin, Mattias Ahnfelt, Eggert Brekkan, Richard Hassett, Steve Peppers, Gustav Rodrigo, Greg Van Slyke, and David (Xiqaojian) Zhao
Iraj Ghazi and David W. Wood
Pérola O. Magalhães and Adalberto Pessoa Jr.
Manuel Mota, Alexander Yelshin, and Inna Yelshina
Catherine H. Schein
Gail Sofer, Craig Robinson, Joanthan Yourkin, Tina Pitarresi, and Darcy Birse
Phil J. Bremer and Richard Brent Seale
Zhiwu Fang
Bob Stover and Ed Domanico
Mirjana Radosevich and Thierry Burnouf
James J. Reilly and Michiel E. Ultee
Pete Gagnon
Per Karsnäs
Tingyue Gu
Chung Lim Law and Arun S. Mujumdar
Jinsong Liu
Philippe Lam and Jamie Moore
John Pieracci and Jörg Thömmes
Manohar Kalyanpur
H .S. C. Barbosa and J. C. Marcos
Joseph Bertolini
Gianluca Di Profio, Efrem Curcio, and Enrico Drioli
Maria-Regina Kula and Klaus Selber
Robert van Reis and Andrew L. Zydney
George Miesegaes, Scott Lute, Hazel Aranha, and Kurt Brorson
Jeffrey N. Odum
Jeffrey Odum
Robert Z. Maigetter, Tom Piombino, Christian Wood, Tom Gervais, Claudio Thomasin, Bryan Shingle, Dave A. Wareheim, and David Clark
Claude Arlois, Jean Didelez, Patrick Florent, and Guy Godeau
Dennis Dobie
P. T. Noble
Nathaniel G. Hentz, PhD
Sandy Weinberg and Carl A. Rockburne
Beth H. Junker
Rakhi B. Shah, Jun T. Park, Erik K. Read, Mansoor A. Khan, and Kurt Brorson
Gary Walsh
Subject Areas: Biology, life sciences [PS]
