Advances in Biochemical Engineering/Biotechnology - Springer

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Advances in Biochemical Engineering/Biotechnology Series Editor: T. Scheper

Editorial Board: W. Babel · I. Endo · S.-O. Enfors · M. Hoare · W.-S. Hu B. Mattiasson · J. Nielsen · G. Stephanopoulos U. von Stockar · G. T. Tsao · R. Ulber · J.-J. Zhong

Advances in Biochemical Engineering/Biotechnology Series Editor: T. Scheper Recently Published and Forthcoming Volumes

Disposable Bioreactors Volume Editor: Eibl, R., Eibl, D. Vol. 115, 2009

Analytics of Protein-DNA Interactions Volume Editor: Seitz, H. Vol. 104, 2007

Engineering of Stem Cells Volume Editor: Martin, U. Vol. 114, 2009

Tissue Engineering II Basics of Tissue Engineering and Tissue Applications Volume Editors: Lee, K., Kaplan, D. Vol. 103, 2007

Biotechnology in China I From Bioreaction to Bioseparation and Bioremediation Volume Editors: Zhong, J.J., Bai, F.-W., Zhang, W. Vol. 113, 2009 Bioreactor Systems for Tissue Engineering Volume Editors: Kasper, C., van Griensven, M., Poertner, R. Vol. 112, 2008 Food Biotechnology Volume Editors: Stahl, U., Donalies, U. E. B., Nevoigt, E. Vol. 111, 2008 Protein – Protein Interaction Volume Editors: Seitz, H., Werther, M. Vol. 110, 2008 Biosensing for the 21st Century Volume Editors: Renneberg, R., Lisdat, F. Vol. 109, 2007 Biofuels Volume Editor: Olsson, L. Vol. 108, 2007 Green Gene Technology Research in an Area of Social Conflict Volume Editors: Fiechter, A., Sautter, C. Vol. 107, 2007 White Biotechnology Volume Editors: Ulber, R., Sell, D. Vol. 105, 2007

Tissue Engineering I Scaffold Systems for Tissue Engineering Volume Editors: Lee, K., Kaplan, D. Vol. 102, 2006 Cell Culture Engineering Volume Editor: Hu, W.-S. Vol. 101, 2006 Biotechnology for the Future Volume Editor: Nielsen, J. Vol. 100, 2005 Gene Therapy and Gene Delivery Systems Volume Editors: Schaffer, D.V., Zhou, W. Vol. 99, 2005 Sterile Filtration Volume Editor: Jornitz, M.W. Vol. 98, 2006 Marine Biotechnology II Volume Editors: Le Gal, Y., Ulber, R. Vol. 97, 2005 Marine Biotechnology I Volume Editors: Le Gal, Y., Ulber, R. Vol. 96, 2005 Microscopy Techniques Volume Editor: Rietdorf, J. Vol. 95, 2005

Disposable Bioreactors Volume Editors: Regine Eibl · Dieter Eibl

With contributions by G. De Abreu · R. Brecht · E. Cameau · G. Catapano · D. Courtois M. Discacciati · J.-P. Ducos · D. Eibl · R. Eibl · J.C. Gerlach A. Glindkamp · U. Gottschalk · D. Hacker · B. Hitzmann M. De Jesus · N. Parolini · J.F. Patzer II · M. Perrone · A. Pralong A. Quarteroni · A. Ravisé · K. F. Reardon · C. Rehbock D. Riechers · D. De Sanctis · T. Scheper · M. Stettler · B. Terrier S. Werner · F. Wurm · X. Zhang

Editors Prof. Dr. Regine Eibl Zurich University of Applied Sciences 8820 Wädenswil Switzerland [email protected]

Prof. Dr. Dieter Eibl Zurich University of Applied Sciences 8820 Wädenswil Switzerland [email protected]

ISSN 0724-6145 e-ISSN 1616-8542 ISBN 978-3-642-01871-8 e-ISBN 978-3-642-01872-5 DOI: 10.1007/978-3-642-01872-5 Springer Heidelberg Dordrecht London New York Library of Congress Control Number: 2009935692  Springer-Verlag Berlin Heidelberg 2009 This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, roadcasting, reproduction on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer. Violations are liable to prosecution under the German Copyright Law. The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Cover design: WMXDesign GmbH, Heidelberg, Germany Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)

Series Editor Prof. Dr. T. Scheper Institute of Technical Chemistry University of Hannover Callinstraße 3 30167 Hannover, Germany [email protected]

Volume Editors Prof. Dr. Regine Eibl

Prof. Dr. Dieter Eibl

Zurich University of Applied Sciences 8820 Wädenswil Switzerland [email protected]

Zurich University of Applied Sciences 8820 Wädenswil Switzerland [email protected]

Editorial Board Prof. Dr. W. Babel

Prof. Dr. S.-O. Enfors

Section of Environmental Microbiology Leipzig-Halle GmbH Permoserstraße 15 04318 Leipzig, Germany [email protected]

Department of Biochemistry` and Biotechnology Royal Institute of Technology Teknikringen 34, 100 44 Stockholm, Sweden [email protected]

Prof. Dr. I. Endo

Prof. Dr. M. Hoare

Saitama Industrial Technology Center 3-12-18, Kamiaoki Kawaguchi-shi Saitama, 333-0844, Japan [email protected]

Department of Biochemical Engineering University College London Torrington Place London, WC1E 7JE, UK [email protected]

Prof. Dr. W.-S. Hu

Prof. Dr. G. T. Tsao

Chemical Engineering and Materials Science University of Minnesota 421Washington Avenue SE Minneapolis, MN 55455-0132, USA [email protected]

Professor Emeritus Purdue University West Lafayette, IN 47907, USA [email protected] [email protected]

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Editorial Board

Prof. Dr. B. Mattiasson

Prof. Dr. Roland Ulber

Department of Biotechnology Chemical Center, Lund University P.O. Box 124, 221 00 Lund, Sweden [email protected]

FB Maschinenbau und Verfahrenstechnik Technische Universität Kaiserslautern Gottlieb-Daimler-Straße 67663 Kaiserslautern, Germany [email protected]

Prof. Dr. J. Nielsen

Prof. Dr. C. Wandrey

Center for Process Biotechnology Technical University of Denmark Building 223 2800 Lyngby, Denmark [email protected]

Institute of Biotechnology Forschungszentrum Jülich GmbH 52425 Jülich, Germany [email protected]

Prof. Dr. G. Stephanopoulos

Prof. Dr. J.-J. Zhong

Department of Chemical Engineering Massachusetts Institute of Technology Cambridge, MA 02139-4307, USA [email protected]

Bio-Building #3-311 College of Life Science & Biotechnology Key Laboratory of Microbial Metabolism, Ministry of Education Shanghai Jiao Tong University 800 Dong-Chuan Road Minhang, Shanghai 200240, China [email protected]





Prof. Dr. U. von Stockar Laboratoire de Génie Chimique et Biologique (LGCB) Swiss Federal Institute of Technology Station 6 1015 Lausanne, Switzerland [email protected]

Honorary Editors Prof. Dr. A. Fiechter

Prof. Dr. K. Schügerl

Institute of Biotechnology Eidgenössische Technische Hochschule ETH-Hönggerberg 8093 Zürich, Switzerland [email protected]

Institute of Technical Chemistry University of Hannover, Callinstraße 3 30167 Hannover, Germany [email protected]

Advances in Biochemical Engineering/ Biotechnology Also Available Electronically

Advances in Biochemical Engineering/Biotechnology is included in Springer’s eBook package Chemistry and Materials Science. If a library does not opt for the whole package the book series may be bought on a subscription basis. Also, all back volumes are available electronically. For all customers who have a standing order to the print version of Advances in Biochemical Engineering/Biotechnology, we offer the electronic version via SpringerLink free of charge. If you do not have access, you can still view the table of contents of each volume and the abstract of each article by going to the SpringerLink homepage, clicking on “Chemistry and Materials Science,” under Subject Collection, then “Book Series,” under Content Type and finally by selecting Advances in Biochemical Bioengineering/Biotechnology You will find information about the – Editorial Board – Aims and Scope – Instructions for Authors – Sample Contribution at springer.com using the search function by typing in Advances in Biochemical Engineering/Biotechnology. Color figures are published in full color in the electronic version on SpringerLink.

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Advances in Biochemical Engineering/Biotechnology

Aims and Scope Advances in Biochemical Engineering/Biotechnology reviews actual trends in ­modern biotechnology. Its aim is to cover all aspects of this interdisciplinary technology where ­knowledge, methods and expertise are required for chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. They give the state-of-the-art of a topic in a comprehensive way thus being a valuable source for the next 3-5 years. It also discusses new discoveries and applications. In general, special volumes are edited by well known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English. In references Advances in Biochemical Engineering/Biotechnology is abbreviated as Adv. Biochem. Engin./Biotechnol. and is cited as a journal. Special volumes are edited by well known guest editors who invite reputed authors for the review articles in their volumes. Impact Factor in 2008: 2.569; Section “Biotechnology and Applied Microbiology”: Rank 48 of 138

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Preface

Over the past five years, the immense financial pressure on the development and manufacturing of biopharmaceuticals has resulted in the increasing use and acceptance of disposables, which are discarded after harvest and therefore intended only for single use. In fact, such disposables are implemented in all the main bioprocess production stages today and an even higher growth than those in the biopharmaceutical market is predicted (reaching double figures). Alongside disposable filter capsules, membrane chromatography units, tubing, connectors, flexible containers processing or containing fluids, freezer systems, mixers and pumps, and fully controlled disposable bioreactors of up to 2,000 L culture volume are already available on the market. Numerous studies highlight the advantages of disposable bioreactors and reveal their potential for simple, safe and fast seed inoculum production, process development and small as well as middle volume production (e.g. bioactive substances, viruses for vaccines and gene therapies etc.). They suggest that such disposable bioreactors (typically characterized by the cultivation chamber or bag from plastic materials) may be advantageous for plant, animal and microbial cells. Running industrial activities such as CFD-modelling, development of single-use process monitoring and control technology, and standardized film formulations are attempting to resolve the limitations of the current disposable bioreactors. These achievements, along with substantial improvements in product yield, will reduce the use of stainless steel in the biomanufacturing facilities of the future. The aim of this volume, which includes eight contributions from renowned experts, is to give an up-to-date overview of the main disposable bioreactors, their working principles, characteristics, known engineering aspects, and potential applications. R. Brecht discusses disposable bioreactor technology development in pharmaceutical glycoprotein manufacturing from the view of the applier (CMO). The advantages of orbital shaken disposable bioreactors from millilitre-to 1 m3-scale are outlined by X. Zhang, M. Stettler, D. De Sanctis, M. Perrone, N. Parolini, M. Discacciati, M. De Jesus, D. Hacker, A. Quarteroni and F. Wurm for animal cell culture-based processes. R. Eibl, S. Werner and D. Eibl focus on a wave-mixed bag bioreactor which, to a large extent, promoted the development of disposable bioreactors. In this context they summarize engineering aspects which provide invaluable information to influence the cultivation procedure positively and xi

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Preface

thereby, the results of cultivations with bioreactors based on wave-induced motion up to 120 L culture volume. The importance of disposable bioreactors for liver tissue engineering and the resulting transport phenomena are described by G. Catapano, J.F. Patzer II and J.C. Gerlach, whereas three new types of disposable bioreactors, which have been developed to cultivate plant cell suspension cultures and somatic embryo cultures, by researchers at Nestlé (J.P. Ducos, B. Terrier, D. Courtois) are presented. Furthermore, the consideration of several aspects closely connected with bioreactors will facilitate readers in deciding for or against disposable alternatives and help them to choose an appropriate system. For the same reason, the availability of disposable sensors for process monitoring and control, as well as suitable equipment for disposable downstream processing, influenced by a bioreactor’s cultivation result, are discussed by A. Glindkamp, D. Riechers, C. Rehbock, B. Hitzmann, T. Scheper and K.F. Reardon, and U. Gottschalk. Finally, the configuration of hybrid and disposable production facilities is addressed by A. Ravisé, E. Cameau, G. De Abreu and A. Pralong. This volume constitutes a reliable resource book, which gives due attention to the most pressing problems to guarantee desired product yields, in combination with product consistency and economic benefits in processes mainly aimed at the production of cells and bioactive substances, using disposable bioreactors and disposable equipment (also partly for downstreaming). The editors are grateful for the support of all the contributors, the series editor Prof. T. Scheper and the publisher, who have made this book possible. Summer 2009

Regine Eibl Dieter Eibl

Contents

Disposable Bioreactors: Maturation into Pharmaceutical Glycoprotein Manufacturing......................................................................... René Brecht Use of Orbital Shaken Disposable Bioreactors for Mammalian Cell Cultures from the Milliliter-Scale to the 1,000-Liter Scale................ Xiaowei Zhang, Matthieu Stettler, Dario De Sanctis, Marco Perrone, Nicola Parolini, Marco Discacciati, Maria De Jesus, David Hacker, Alfio Quarteroni, and Florian Wurm

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Bag Bioreactor Based on Wave-Induced Motion: Characteristics and Applications.................................................................. Regine Eibl, Sören Werner, and Dieter Eibl

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Disposable Bioreactors for Plant Micropropagation and Mass Plant Cell Culture.......................................................................... Jean-Paul Ducos, Bénédicte Terrier, and Didier Courtois

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Transport Advances in Disposable Bioreactors for Liver Tissue Engineering......................................................................... 117 Gerardo Catapano, John F. Patzer II, and Jörg Christian Gerlach Sensors in Disposable Bioreactors Status and Trends....................................................................................................... 145 Anne Glindkamp, Daniel Riechers, Christoph Rehbock, Bernd Hitzmann, Thomas Scheper, and Kenneth F. Reardon Disposables in Downstream Processing........................................................ 171 Uwe Gottschalk Hybrid and Disposable Facilities for Manufacturing of Biopharmaceuticals: Pros and Cons............................................................. 185 Aline Ravisé, Emmanuelle Cameau, Georges De Abreu, and Alain Pralong Index................................................................................................................. 221 xiii