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Dr. Michael C. Flickinger is Associate Director for Academic Programs of the Golden LEAF Biomanufacturing Training and Education Center (BTEC) and a Professor of Chemical and Biomolecular Engineering at North Carolina State University, Raleigh.
Preface ix
Contributors xi
PART I INTRODUCTION 1
1 Bioprocess Design, Computer-Aided 5Victor Papavasileiou, Charles Siletti, Alexandros Koulouris, and Demetri Petrides
PART II DOWNSTREAM RECOVERY OF CELLS AND PROTEIN CAPTURE 25
2 Cell Separation, Centrifugation 27Hans Axelsson
3 Cell Disruption, Micromechanical Properties 49Ingo Kampen and Arno Kwade
4 Cell Separation, Yeast Flocculation 65Eduardo V. Soares
5 Cell Wall Disruption and Lysis 81F. A. P. Garcia
6 Expanded Bed Chromatography, Surface Energetics of Biomass Deposition 95Marcelo Fernandez Lahore, Oscar Aguilar, Rami Reddy Vennapusa and Muhammad Aasin
7 Filter Aids 107Tony Hunt
8 Protein Adsorption, Expanded Bed 115Siddartha Ghose
PART III PROCESS DEVELOPMENT IN DOWNSTREAM PURIFICATION 127
9 Scaledown of Biopharmaceutical Purification Operations 129Anurag S. Rathore and Varsha S. Joshi
10 Adsorption in Simulated Moving Beds (SMB) 147Cesar C. Santana, Ivanildo J. Silva Jr., Diana C. S. Azevedo, and Amaro G. Barreto Jr.
11 Adsorption of Proteins with Synthetic Materials 179Joseph McGuire and Omkar Joshi
12 Affinity Fusions for Protein Purification 191Susanne Gräslund and Martin Hammarström
13 Bioseparation, Magnetic Particle Adsorbents 201Urs Alexander Peuker, Owen Thomas, Timothy John Hobley, Mathias Franzreb, Sonja Berensmeier, Maria Shäfer, and Birgit Hickstein
14 High Throughput Technologies in Bioprocess Development 221Trent Carrier, Eva Heldin, Mattias Ahnfelt, Eggert Brekkan, Richard Hassett, Steve Peppers, Gustav Rodrigo, Greg Van Slyke, and David (Xiqaojian) Zhao
15 Large-Scale Protein Purification, Self-Cleaving Aggregation Tags 257Iraj Ghazi and David W. Wood
16 Lipopolysaccharide, LPS removal, Depyrogenation 269Pérola O. Magalhães and Adalberto Pessoa Jr.
17 Porous Media in Biotechnology 277Manuel Mota, Alexander Yelshin, and Inna Yelshina
18 Protein Aggregation and Precipitation, Measurement and Control 293Catherine H. Schein
PART IV EQUIPMENT DESIGN FOR DOWNSTREAM RECOVERY AND PROTEIN PURIFICATION 325
19 Cleaning and Sanitation in Downstream Processes 327Gail Sofer, Craig Robinson, Joanthan Yourkin, Tina Pitarresi, and Darcy Birse
20 Clean-in-place 343Phil J. Bremer and Richard Brent Seale
21 Large Scale Chromatography Columns, Modeling Flow Distribution 353Zhiwu Fang
22 Pumps, Industrial 373Bob Stover and Ed Domanico
PART V DOWNSTREAM cGMP OPERATIONS 389
23 Affinity Chromatography of Plasma Proteins 391Mirjana Radosevich and Thierry Burnouf
24 Antibody Purification, Monoclonal and Polyclonal 405James J. Reilly and Michiel E. Ultee
25 Chromatographic Purification of Virus Particles 415Pete Gagnon
26 Chromatography, Hydrophobic Interactions 437Per Karsnäs
27 Chromatography, Radar Flow 449Tingyue Gu
28 Drying, Biological Materials 465Chung Lim Law and Arun S. Mujumdar
29 Freeze-Drying, Pharmaceuticals 485Jinsong Liu
30 Freezing, Biopharmaceutical 505Philippe Lam and Jamie Moore
31 Membrane Chromatography 521John Pieracci and Jörg Thömmes
32 Membrane Separations 545Manohar Kalyanpur
33 Plasmid Purification 557H .S. C. Barbosa and J. C. Marcos
34 Protein Chromatography, Manufacturing Scale 571Joseph Bertolini
35 Protein Crystallization, Kinetics 579Gianluca Di Profio, Efrem Curcio, and Enrico Drioli
36 Protein Purification, Aqueous Liquid Extraction 603Maria-Regina Kula and Klaus Selber
37 Protein Ultrafiltration 617Robert van Reis and Andrew L. Zydney
38 Virus Retentive Filters 641George Miesegaes, Scott Lute, Hazel Aranha, and Kurt Brorson
PART VI BIOPHARMACEUTICAL FACILITY VALIDATION 655
39 Biopharmaceutical Facility Design and Validation 657Jeffrey N. Odum
40 Closed Systems in Bioprocessing 677Jeffrey Odum
41 Facility Design for Single Use (SU) Downstream Materials 685Robert Z. Maigetter, Tom Piombino, Christian Wood, Tom Gervais, Claudio Thomasin, Bryan Shingle, Dave A. Wareheim, and David Clark
42 eGMPs for Production Rooms 715Claude Arlois, Jean Didelez, Patrick Florent, and Guy Godeau
43 Heating, Ventilation, and Air Conditioning 731Dennis Dobie
44 Sterilization-in-Place (SIP) 747P. T. Noble
PART VII FDA cGMP REGULATORY COMPLIANCE 757
45 Pharmaceutical Bioburden Testing 759Nathaniel G. Hentz, PhD
46 Chromatography, Industrial Scale Validation 775Sandy Weinberg and Carl A. Rockburne
47 GMPs and GLSPs 795Beth H. Junker
48 Quality by Design (QBD) 815Rakhi B. Shah, Jun T. Park, Erik K. Read, Mansoor A. Khan, and Kurt Brorson
49 Regulatory Requirements, European Community 829Gary Walsh
Index 843
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