Handbook of Industrial Cell Culture

Transcription

1 Handbook of Industrial Cell Culture

2 Handbook of Industrial Cell Culture Mammalian, Microbial, and Plant Cells Edited by Victor A. Vinci, PhD Eli Lilly and Company, and Sarad R. Parekh, PhD Dow AgroSciences, Springer Science+Business Media, LLC

3 ISBN ISBN (ebook) DOI / Springer Science+Business Media New York Originally published by Humana Press Inc. in 2003 Softcover reprint of the hardcover 1 st edition 2003 humanapress.com AII rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise without written permis sion from the Publisher. AII authored papers, comments, opinions, conclusions, or recommendations are those of the author(s), and do not necessarily reflect the views of the publisher. This publication is printed on acid-free ANSI Z (American Standards Institute) Permanence of Paper for Printed Library Materials. Production Editor: Mark J. Breaugh. Cover illustration: (Abstraction of) Maternal inheritance of plastid transgenes. See Fig. 3 on page 265. Cover design: Patricia Cleary. For additional copies, pricing for bulk purchases, and/or information about other Humana titles, contact Humana at the above address or at any ofthe following numbers: Tel.: ; Fax: ; humana@humanapr.com Photocopy Authorization Policy: Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Springer Science+Business Media, LLC, provided that the base fee ofus $20.00 per copy, is paid directly to the Copyright Clearance Center at 222 Rosewood Drive, Danvers, MA For those organizations that have been granted a photocopy license from the CCC, a separate system of payment has been arranged and is acceptable to Springer Science+Business Media, LLC. The fee code for users of the Transactional Reporting Service is: [ /03 $20.00] Library of Congress Cataloging in Publication Data Handbook of industrial cell culture : mammalian, microbial, and plant cells / edited by Victor A. Vinci and Sarad R. Parekh. p.cm. Includes bibliographical references and index. 1. Cell culture--handbooks, manuals, etc. 2. Biotechnology--Handbooks, manuals, etc. 1. Parekh, Sarad R., II. Vinci, Victor. TP C44 H dc

4 Preface The essential and determining feature of an industrial bioprocess is the culturing of cells that yield a desired product. Mammalian, microbial, and plant cells are traditionally used for the manufacture of products derived directly or semisynthetic ally from cellular metabolites. These cells are increasingly used as the cellular machinery to express recombinant proteins of considerable economic and therapeutic value. The choice of cell culture type determines the degree of success in obtaining a clinically useful product, as well as in achieving an economical process, by facilitating acceptable yield and purity. Each of the major classes of industrially relevant cultures is manipulated by a variety of means, selected for desired phenotypes, and is exploited either in bioreactors or in the field by functionally similar approaches. The knowledge of how best to achieve this utility has its roots in empirical learning that reaches back many thousands of years. Much later, Pasteur, Koch, and others dramatically advanced our knowledge of the underlying cellular nature of bioprocesses during classical studies in the 19th century using modem scientific methods. Following World War II, the advent of modem industrial production methods, inspired by the discovery and isolation of penicillin, brought the first boom in natural product biotechnology. More recently, the dramatic acceleration in identifying protein biopharmaceutical candidates, as well as the current rebirth in natural product discovery, have been driven by molecular genetics. Likewise, plant cell culture and engineered crops have already impacted agriculture and are poised to revolutionize biotechnology. The progression of transgenic animal and plant methodologies from laboratory to industrial scale production has resulted in the most recent, and perhaps most dramatic, step in using cells to make products. Supporting the production of novel therapeutics in mammalian, microbial, and plant cells is an impressive array of new methodologies from the fields of molecular genetics, proteomics, genomics, analytical biochemistry, and screening. For an industrial bioprocess, manipulation and propagation of cells in order to elicit expression of a product is followed by the recovery, analysis, and identification of these products. The methodology for successfully developing a commercial process is functionally similar across the spectrum of cell types. Handbook of Industrial Cell Culture: Mammalian, Microbial, and Plant Cells attempts to link these common approaches, while also delineating those specific aspects of cell types, to give the reader not only an overview of the best current practices, but also of today's evolving technologies, with examples of both their practical applications and their future potential. Many scientists currently in the field find their careers transitioning across work with mammalian, microbial, and plant bioprocesses; thus they are very much in need of a book linking these disciplines in a single format. Moreover, the next generation of scientists and engineers will interface across these disciplines and likely see even more dramatic enhancements in technology. Our hope is that this Handbook will prove especially useful not only to those involved in biotechnology as a broad discipline, but also assist experienced practitioners in perfecting the special art of industrial cell culture. v Victor A. Vinci Sarad R. Parekh

5 Contents Preface... v Contributors... ix PART I. MAMMALIAN CELL CULTURE 1 Analysis and Manipulation of Recombinant Glycoproteins Manufactured in Mammalian Cell Culture... 3 Nigel Jenkins 2 Genetic Approaches to Recombinant Protein Production in Mammalian Cells Peter P. Mueller, Dagmar Wirth, Jacqueline Un singer, and Hansjorg Hauser 3 Protein Expression Using Transgenic Animals William H. Velander and Kevin E. van Cott 4 Mammalian Cell Culture: Process Development Considerations Steven Rose, Thomas Black, and Divakar Ramakrishnan PART II. MICROBIAL CELL CULTURE 5 Natural Products: Discovery and Screening Matthew D. Hilton 6 Genetic Engineering Solutions for Natural Products in Actinomycetes Richard H. Baltz 7 Culture Medium Optimization and Scale-Up for Microbial Fermentations Neal C. Connors PART III. PLANT CELL CULTURE 8 Functional Genomics for Plant Trait Discovery Sam Reddy, Ignacio M. Larrinua, Max O. Ruegger, Vi pula K. Shukla, and Yuejin Sun 9 Molecular Tools for Engineering Plant Cells Donald J. Merlo 10 Plant Cell Culture: A Critical Tool for Agricultural Biotechnology Joseph F. Petolino, Jean L. Roberts, and Ponsamuel Jayakumar 11 Expression of Recombinant Proteins via the Plastid Genome Jeffrey M. Staub 12 Oleosin Partitioning Technology for Production of Recombinant Proteins in Oil Seeds Maurice M. Moloney vii

6 viii Contents PART IV. CRITICAL TOOLS FOR BIOTECHNOLOGY 13 Genome Sequencing and Genomic Technologies in Drug Discovery and Development Lawrence M. Gelbert 14 Proteomics Gerald W. Becker, Michael D. Knierman, Pavel Shiyanov, and John E. Hale 15 Metabolic Flux Analysis, Modeling, and Engineering Solutions Walter M. van Gulik, Wouter A. van Winden, and Joseph J. Heijnen 16 Advances in Analytical Chemistry for Biotechnology: Mass Spectrometry of Peptides, Proteins, and Glycoproteins Jeffrey S. Patrick 17 DNA Shuffling for Whole Cell Engineering Steve del Cardayre and Keith Powell 18 Cell Culture Preservation and Storage for Industrial Bioprocesses James R. Moldenhauer Index

7 Contributors RICHARD H. BALTZ Cubist Pharmaceuticals, Lexington, MA GERAW W. BECKER Proteomics, Eli Lilly and Company, THOMAS BLACK Bioprocess Research and Development, Eli Lilly and Company, STEVE DEL CARDAYRE Maxygen, Redwood City, CA NEAL C. CONNORS Biocatalysis & Fermentation Development, Merck Research Laboratories, Rahway, NJ LAWRENCE M. GELBERT Functional Genomics, Lilly Research Laboratories, Eli Lilly and Company, JOHN E. HALE Proteomics, Eli Lilly and Company, HANSJORG HAUSER Gesellschaftfiir Biotechnologische Forschung (GBF), Braunschweig, Germany JOSEPH J. HEIJNEN Laboratory for Biotechnology, Delft University of Technology, Delft, The Netherlands MATTHEW D. HILTON Bioprocess Fermentation Development, Eli Lilly and Company, PONSAMUEL JAYAKUMAR Plant Trait Discovery Research, Dow AgroSciences, NIGEL JENKINS Bioprocess Research and Development, Eli Lilly and Company, MICHAEL D. KNIERMAN Proteomics, Eli Lilly and Company, IGNACIO M. WRINUA Molecular Biology and Traits, Dow AgroSciences, DONAW J. MERLO Molecular Biology and Traits, Dow AgroSciences, JAMES R. MOWENHAUER Central Culture Preservation, Eli Lilly and Company, MAURICE M. MOLONEY Plant Biotechnology, The University of Calgary, Calgary, Canada PETER P. MUEllER Gesellschaftfiir Biotechnologische Forschung (GBF), Braunschweig, Germany SARAD R. PAREKH, Supply Research and Development, Dow AgroSciences, JEFFREY S. PATRICK Analytical Department, Eli Lilly and Company, JOSEPH F. PETOUNO Plant Transformation and Gene Expression, Dow AgroSciences, ix

8 x Contributors KEITH POWELL Maxygen, Redwood City, CA DIVAKAR RAMAKRISHNAN Bioprocess Research and Development, Eli Lilly and Company, SAM REDDY Molecular Biology and Traits, Dow AgroSciences, JEAN L. ROBERTS Plant Transformation and Gene Expression, Dow AgroSciences, STEVEN ROSE Bioprocess Research and Development, Eli Lilly and Company, MAX O. RUEGGER Molecular Biology and Traits, Dow AgroSciences, PAVEL SHIYANOV Proteomics, Eli Lilly and Company, VIPULA K. SHUKLA Molecular Biology and Traits, Dow AgroSciences, JEFFREY M. STAUB Plant Genetics Division, Monsanto Company, St. Louis, MO YUEJIN SUN Molecular Biology and Traits, Dow AgroSciences, JACQUEUNE UNSINGER GeseUschaftfiir Biotechnologische Forschung (GBF), Braunschweig, Germany WILUAM H. VELANDER Department of Chemical Engineering, Virginia Polytechnic Institute, Blacksburg, VA KEVIN E. VAN COTT Department of Chemical Engineering, Virginia Polytechnic Institute, Blacksburg VA WALTER M. VAN GUUK Laboratory for Biotechnology, Delft University of Technology, Delft, The Netherlands WOUTER A. VAN WINDEN Laboratory for Biotechnology, Delft University of Technology, Delft, The Netherlands VICTOR A. VINCI Bioprocess Commercial Development, Eli Lilly and Company, DAGMAR WIRTH GeseUschaftfiir Biotechnologische Forschung (GBF), Braunschweig, Germany