UPSTREAM INDUSTRIAL BIOTECHNOLOGY
UPSTREAM INDUSTRIAL BIOTECHNOLOGY
Edited By
MICHAEL C. FLICKINGER Golden LEAF Biomanufacturing Training and Education Center (BTEC) Department of Chemical and Biomolecular Engineering North Carolina State University, Raleigh North Carolina, USA
A JOHN WILEY & SONS, INC., PUBLICATION
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Library of Congress Cataloging-in-Publication Data: Upstream industrial biotechnology / edited by Michael C. Flickinger. v. cm Includes bibliographical references and index. Contents: volume 1. Expression Systems and Process Development–volume 2. Equipment, Process Design, Sensing, Control and cGMP Operations. ISBN 978-1-118-13123-7 (set : hardback) 1. Biotechnology. I. Flickinger, Michael C., editor of compilation. II. Encyclopedia of industrial biotechnology. Selections. TP248.2.U675 2013 660.6–dc23 2012030697 Printed in the United States of America 10 9 8 7 6 5 4 3 2 1
CONTENTS
VOLUME I: EXPRESSION SYSTEMS & PROCESS DEVELOPMENT PREFACE
xi
CONTRIBUTORS
PART I
INTRODUCTION
xiii
3
PART II INDUSTRIAL CELL GROWTH AND GENE EXPRESSION SYSTEMS
7
1
9
Animal Cells, Suspension Culture John R. Birch
2
Baculovirus Expression Systems
19
Robert D. Possee, Richard B. Hitchman, and Linda A. King
3
Baculovirus Kinetics, Insect Culture
33
Leslie Chan, Steve Reid, and Lars Keld Nielsen
4
Cell Culture, Aseptic Techniques
49
John M. Davis and Kevin L. Shade
5
Cell Cycle in Bioprocesses
71
Mariam Naciri and Mohamed Al-rubeai
6
Cell Growth and Protein Expression Kinetics
85
Dhinakar S. Kompala v
vi
7
CONTENTS
Cell Viability Measurement
97
Ning Wei and Benjamin Sommer
8
Contamination Detection in Animal Cell Culture
105
Carol Mclean and Colin Harbour
9
Culture Collections and Biological Resource Centers (BRCs)
131
David Smith
10
Culture Preservation
153
Robert L. Gherna
11
Expression and Secretion of Heterologous Proteins, Bacillus and Other Gram-Positive Bacteria
163
Boyke Bunk, Rebekka Biedendieck, Dieter Jahn, and Patricia S. Vary
12
Gene Expression in Human Cells
181
Marco A. Cacciuttolo, Gene Lee, John Chon, and John Lewis
13
Gene expression in Pichia and other methylotroph yeast
195
Koti Sreekrishna
14
Gene Expression in Recombinant Animal Cells and Transgenic Animals
213
Richard M. Twyman and Bruce Whitelaw
15
Inoculum Expansion Methods, Animal Cell Lines
297
Claudia Kloth, Glenn Maclsaac, Haile Ghebremariam, and Alahari Arunakumari
16
Insect Cell Culture
311
Someet Narang, Erik M. Whiteley, Sunyia Hussain, and Michael J. Betenbaugh
17
Kinetics of Microbial Growth
331
Nicolai S. Panikov
18
Microalgae, Mass Culture Methods
371
Em´ılio Molina Grima, Jose Mar´ıa Fern´andez Sevilla, and Francisco Gabriel Aci´en Fern´aNdez
19
Microbial Growth Measurement
399
Arthur L. Koch
20
Microbial Media Composition
413
Rosalie J. Cote
21
Microscopic Characterization of Cells
437
Erwin Huebner
22
Mycoplasma Contamination of Cell Cultures Cord C. Uphoff and Hans G. Drexler
467
CONTENTS
23
Protein Glycosylation: Analysis, Characterization, and Engineering
489
Mikael R. Andersen, Jong Hyun Nam, and Susan T. Sharfstein
24
Secretion of Heterologous Proteins, Gram Positive Bacteria
543
Eric Morello, Isabelle Poquet, Philippe Langella
25
Soluble Protein Expression in Bacteria
557
Catherine H. Schein
PART III MEDIA, CELL LINES AND PROCESS DEVELOPMENT
579
26
581
Animal Cell Culture Media Natarajan Vijayasankaran, Jincai Li, Robert Shawley, Aaron Chen, Masaru Shiratori, Martin Gawlitzek, Feng Li, Robert Kiss, and Ashraf Amanullah
27
Animal Cell Culture, Effects of Osmolality and Temperature
599
James C. Warren and Shyamsundar Subramanian
28
Animal Cell Stability
617
Martin S. Sinacore, Timothy S. Charlebois, Denis Drapeau, Mark Leonard, Scott Harrison, and S. Robert Adamson
29
Animal Cell Types, Hybridomas
635
K. Heilmann and B. Micheel
30
Antibody Production, Human Recombinant
645
Stefan D¨ubel
31
Antifoams and Pluronic Polyols, Cell Protection
663
David W. Murhammer
32
Biominiaturization of Bioreactors
669
Michael A. Hanson and Govind Rao
33
Inoculum Preparation
699
Craig J.L. Gershater
34
Microcarrier Culture
711
Susan T. Sharfstein and Christian Kaisermayer
35
Monoclonal Antibody Production, Cell Lines
733
Julia F. Markusen and David K. Robinson
36
Plant Cell Culture, Laboratory Techniques
747
Mark Richard Fowler
37
Scale-Up of Biotechnological Processes Marko Zlokarnik
759
vii
viii
CONTENTS
VOLUME II: EQUIPMENT, PROCESS DESIGN, SENSING, CONTROL, AND cGMP OPERATIONS PREFACE
ix
CONTRIBUTORS
xi
PART IV BIOREACTOR DESIGN, ENGINEERING, PROCESS SENSING AND CONTROL
789
38
791
Aeration, Mixing, and Hydrodynamics in Animal Cell Bioreactors Ruben Godoy-Silva, Claudia Berdugo, and Jeffrey J. Chalmers
39
Biocatalytic Membrane Reactors
821
Lidietta Giorno and Enrico Drioli
40
Bioreactor Scale-Down
847
Laura A. Palomares, Alvaro R. Lara, and Octavio T. Ram´ırez
41
Bioreactor Scale-Up
863
Laura A. Palomares and Octavio T. Ram´ırez
42
Bioreactors: Airlift Reactors
887
J.C. Merchuk and F. Garcia Camacho
43
Bioreactors, Continuous Culture of Plant Cells
955
H.J.G. Ten Hoopen
44
Bioreactors, Fluidized-Bed
963
Winfried Storhas
45
Bioreactors, Gas-Treatment
979
Graham Andrews and William Apel
46
Bioreactors, Perfusion
995
Wei Wen Su
47
Bioreactors: Rotating Biological Contactors
1013
Susana Cortez, Pilar Teixeira, Ros´ario Oliveira, and Manuel Mota
48
Bioreactors, Stirred Tank for Culture of Plant Cells
1031
Pauline M. Doran
49
Cell Immobilization, Engineering Aspects
1069
Ronnie Willaert
50
Fermenter/Bioreactor Design
1101
Marvin Charles and Jack Wilson
51
Gas-Holdup in Bioreactors Christian Sieblist and Andreas L¨ubbert
1137
CONTENTS
52
Immobilization of Proteins and Enzymes, Mesoporous Supports
1147
Martin Hartmann and Dirk Jung
53
Immobilized Cells
1179
Manojlovi´c Verica, Bugarski Branko, and Nedovi´c Viktor
54
Immobilized Enzymes
1201
Jose M. Guisan, Lorena Betancor, and Gloria Fernandez-Lorente
55
Impeller Selection, Animal Cell Culture
1219
Alvin W. Nienow
56
Mammalian Cell Bioreactors
1233
Weichang Zhou, Gargi Seth, Maria J. Guardia, and Wei-Shou Hu
57
Mammalian Cell Culture Reactors, Scale-Up
1245
J. Bryan Griffiths
58
Mass Transfer
1261
Yusuf Chisti
59
Oxygen Transfer Rate Determination Methods
1303
Felix Garcia-Ochoa and Emilio Gomez
60
Photobioreactors
1327
Mario R. Tredici, Graziella Chini Zittelli and Liliana Rodolfi
61
Rheological Behavior of Fermentation Fluids
1347
Colin R. Thomas and Grainne L. Riley
62
Rheology of Filamentous Microorganisms, Submerged Culture
1359
Maria Papagianni
63
Sampling and Sample Handling for Process Control
1377
Bo Mattiasson and Martin Hedstr¨om
64
Solid State Fermentation, Kinetics
1387
David A. Mitchell, Deidre M. Stuart, and Robert D. Tanner
65
Solid Substrate Fermentation, Automation
1413
Mario Fern´andez-fern´andez and J. Ricardo P´erez-correa
66
Stainless Steels
1427
C.P. Dillon
67
Static Mixing, Fermentation Processes
1435
Radu Z. Tudose and Maria Gavrilescu
68
Transfer Phenomena in Multiphase Systems Rodica-Viorica Roman
1451
ix
x
CONTENTS
PART V 69
PROCESS ANALYTICAL TECHNOLOGIES (PAT)
Bioprocess and Fermentation Monitoring
1469 1471
Michael Pohlscheidt, Salim Charaniya, Marco Jenzsch, Christopher Bork, Tim L. Noetzel, and Andreas Luebbert
70
Flow Injection Analysis in Industrial Biotechnology
1493
Elo Harald Hansen and Manuel Mir´o
71
Fluorescence Techniques for Bioprocess Monitoring
1511
Fabienne Anton, Carsten Lindemann, Bernd Hitzmann, Kenneth F. Reardon, and Thomas Scheper
72
Off-Line Analysis in Animal Cell Culture
1523
Heino B¨untemeyer
73
Process Analytical Technology: Strategies for Biopharmaceuticals
1543
Anurag S. Rathore and Gautam Kapoor
74
Vent Gas Analysis
1567
David Pollard and Jens Christensen
PART VI UPSTREAM cGMP OPERATIONS
1585
75
1587
Antibody Manufacture, Disposable Systems Regine Eibl and Dieter Eibl
76
Bioreactor Operations
1595
David R. Gray
77
Bioreactors, Cell Culture, Commercial Production
1635
Tan-Che Zhou, Wen-Wen Zhou, Weiwei Hu, and Jian-Jiang Zhong
78
Biotransformation, Process Optimization
1665
Lutz Hilterhaus, Andreas Liese, and Udo Kragl
79
Foam Formation and Control in Bioreactors
1679
Frank Delvigne and Jean-Paul Lecomte
80
Pilot Plants, Design and Operation
1695
Beth H. Junker
81
Shear Sensitivity
1719
Yusuf Chisti
82
Sterilization and Decontamination, Bioprocess Equipment
1763
Peter L. Roberts
INDEX
1781
PREFACE
Upstream Industrial Biotechnology is a compilation of essential in depth articles, organized topically and listed in alphabetical format, for biopharmaceutical, bioprocess and biologics process scientists, engineers and regulatory professionals from the comprehensive seven volumes of the Encyclopedia of Industrial Biotechnology. Process development for the manufacture of complex biomolecules involves solving many scientific, compliance and technical problems quickly in order to support pilot, preclinical and clinical development, technology transfer and manufacturing start-up. Every organization develops new processes from accumulated process knowledge. Accumulated process knowledge has a very significant impact on accelerating the time to market (and reducing the financial resources required) of products manufactured using recombinant DNA and living microbes, cells, transgenic plants or transgenic mammals. However, when an entirely new upstream platform is needed, there are few books that will quickly provide the depth of industry-relevant background. Upstream Industrial Biotechnology can fill this void as a 2 volume advanced desk reference. These volumes include relevant biology, protein purification and
engineering literature with abundant process examples provide by industry subject matter experts (SMEs) and academic scholars. This desk reference will also be useful for advanced biomanufacturing students and professionals to quickly gain in depth knowledge on how to design processes (and facilities) capable of being licensed to manufacture enzymes, biopharmaceutical intermediates, human and veterinary biopharmaceuticals or vaccines. The opportunity is yours to leverage the combined knowledge from scores of industry professionals from around the world who have contributed to Upstream Industrial Biotechnology to reduce the time and cost to deliver engineered proteins, biomolecules and cost-effective biologics to the market and especially to millions of patients worldwide. Professor Michael C. Flickinger, Editor Golden LEAF Biomanufacturing Training and Education Center (BTEC) Department of Chemical and Biomolecular Engineering North Carolina State University Raleigh, North Carolina, 27695-7928, USA
xi
Contributors
S. Robert Adamson, Genetics Institute, Andover, Massachusetts, USA
Christopher Bork, Genentech Inc., Manufacturing Science and Technology, Oceanside, California, USA
Mohamed Al-rubeai, University College Dublin, Belfield, Dublin, Ireland
Bugarski Branko, University of Belgrade, Belgrade, Republic of Serbia
Ashraf Amanullah, Oceanside Process Research & Development, Genentech. Inc, Oceanside, California, USA
Boyke Bunk, Institute of Microbiology, Technische Universit¨at Braunschweig, Braunschweig, Germany
Mikael R. Andersen, Technical University of Denmark, Department of Systems Biology, Lyngby, Denmark
Marco A. Cacciuttolo, Percivia LLC, Cambridge, Massachusetts, USA
Graham Andrews, MMBD Consulting, Gresham, Oregon, USA
F. Garcia Camacho, Universidad de Almeria, Almeria, Spain
Fabienne Anton, Institut f¨ur Technische Chemie, Gottfried Wilhelm Leibniz Universit¨at Hannover, Hannover, Germany
Jeffrey J. Chalmers, The Ohio State University, Columbus, Ohio, USA
William Apel, Idaho National Engineering and Environmental Laboratory, Idaho Falls, Idaho, USA
Leslie Chan, Australian Institute for Bioengineering and Nanotechnology, University of Queensland, Brisbane, Australia
Alahari Arunakumari, Medarex, Inc., Bloomssbury, New Jersey, USA
Salim Charaniya, Genentech Inc., Manufacturing Science and Technology, Oceanside, California, USA
Heino Buntemeyer, Institute of Cell Culture Technology, ¨ University of Bielefeld, Bielefeld, Germany
Timothy S. Charlebois, Genetics Institute, Andover, Massachusetts, USA
Claudia Berdugo, The Ohio State University, Columbus, Ohio, USA
Marvin Charles, Lehigh University, Bethlehem, Pennsylvania, USA
Lorena Betancor, Instituto de Catalisis, CSIC, Madrid, Spain
Aaron Chen, Oceanside Process Research & Development, Genentech. Inc, Oceanside, California, USA
Michael J. Betenbaugh, Johns Hopkins University, Baltimore, Maryland, USA Rebekka Biedendieck, Protein Science Group, University of Kent, Canterbury, Kent, United Kingdom
Yusuf Chisti, School of Engineering, Massey University, School of Engineering, Palmerston North, New Zealand
John R. Birch, Lonza Biologics plc, Berkshire, United Kingdom
John Chon, Percivia LLC, Cambridge, Massachusetts, USA xiii
