UPSTREAM INDUSTRIAL BIOTECHNOLOGY

Aci´en Fern´aNdez 19 Microbial Growth Measurement 399 Arthur L. Koch 20 Microbial Media Composition 413 Rosalie J. Cote 21 Microscopic Characterizatio...

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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

Copyright © 2013 by John Wiley & Sons, Inc. All rights reserved Published by John Wiley & Sons, Inc., Hoboken, New Jersey Published simultaneously in Canada No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400, fax (978) 750-4470, or on the web at www.copyright.com. Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permission. Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. For general information on our other products and services or for technical support, please contact our Customer Care Department within the United States at (800) 762-2974, outside the United States at (317) 572-3993 or fax (317) 572-4002. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic formats. For more information about Wiley products, visit our web site at www.wiley.com.

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