Standardisation in cell and tissue engineering: Methods and protocols

266 Pages·2013·9.231 MB·English

by  Vehid Salih

Standardisation in cell and tissue engineering

© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd i 7/9/2013 2:24:09 PM
Related titles:
Progenitor and stem cell technologies and therapies
(ISBN 978-1-84569-984-0)
Electrospinning for tissue regeneration
(ISBN 978-1-84569-741-9)
Biomaterials and regenerative medicine in ophthalmology
(ISBN 978-1-84569-443-2)
Details of these books and a complete list of titles from Woodhead Publishing can
be obtained by:
(cid:129) visiting our web site at www.woodheadpublishing.com
(cid:129) contacting Customer Services (e-mail: [email protected]; fax:
[phone]; tel.: [phone] ext. 130; address: Woodhead
Publishing Limited, 80, High Street, Sawston, Cambridge CB22 3HJ, UK)
(cid:129) in North America, contacting our US offi ce (e-mail: usmarketing@
woodheadpublishing.com; tel.: [phone]; address: Woodhead Publishing,
1518 Walnut Street, Suite 1100, Philadelphia, PA 19102-3406, USA)
If you would like e-versions of our content, please visit our online platform: www.
woodheadpublishingonline.com. Please recommend it to your librarian so that
everyone in your institution can benefi t from the wealth of content on the site.
We are always happy to receive suggestions for new books from potential editors.
To enquire about contributing to our Biomaterials series, please send your name,
contact address and details of the topic/s you are interested in to laura.overend@
woodheadpublishing.com. We look forward to hearing from you.
The team responsible for publishing this book:
Commissioning Editor: Laura Overend
Publications Coordinator: Emily Cole
Project Editor: Kate Hardcastle
Editorial and Production Manager: Mary Campbell
Production Editor: Mandy Kingsmill
Project Manager: Newgen Knowledge Works Pvt Ltd
Copyeditor: Newgen Knowledge Works Pvt Ltd
Proofreader: Newgen Knowledge Works Pvt Ltd
Cover Designer: Terry Callanan

© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd ii 7/9/2013 2:24:09 PM
Woodhead Publishing Series in Biomaterials: Number 58
Standardisation in cell
and tissue engineering
Methods and protocols
Edited by
Vehid Salih

Oxford Cambridge Philadelphia New Delhi
© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd iii 7/9/2013 2:24:09 PM
Published by Woodhead Publishing Limited,
80 High Street, Sawston, Cambridge CB22 3HJ, UK
www.woodheadpublishing.com
www.woodheadpublishingonline.com
Woodhead Publishing, 1518 Walnut Street, Suite 1100, Philadelphia,
PA 19102-3406, USA
Woodhead Publishing India Private Limited, 303, Vardaan House, 7/28 Ansari Road,
Daryaganj, New Delhi - 110002, India
www.woodheadpublishingindia.com
First published 2013, Woodhead Publishing Limited
© Woodhead Publishing Limited, 2013. Note: the publisher has made every effort to
ensure that permission for copyright material has been obtained by authors wishing to
use such material. The authors and the publisher will be glad to hear from any copyright
holder it has not been possible to contact.
The authors have asserted their moral rights.
This book contains information obtained from authentic and highly regarded
sources. Reprinted material is quoted with permission, and sources are indicated.
Reasonable efforts have been made to publish reliable data and information, but
the authors and the publisher cannot assume responsibility for the validity of all
materials. Neither the authors nor the publisher, nor anyone else associated with
this publication, shall be liable for any loss, damage or liability directly or indirectly
caused or alleged to be caused by this book.
Neither this book nor any part may be reproduced or transmitted in any form or
by any means, electronic or mechanical, including photocopying, microfi lming and
recording, or by any information storage or retrieval system, without permission in
writing from Woodhead Publishing Limited.
The consent of Woodhead Publishing Limited does not extend to copying for
general distribution, for promotion, for creating new works, or for resale. Specifi c
permission must be obtained in writing from Woodhead Publishing Limited for
such copying.
Trademark notice: Product or corporate names may be trademarks or registered
trademarks, and are used only for identifi cation and explanation, without intent to
infringe.
British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library.
Library of Congress Control Number: 2013940961

ISBN 978-0-85709-419-3 (print)
ISBN 978-0-85709-872-6 (online)
ISSN 2049-9485 Woodhead Publishing Series in Biomaterials (print)
ISSN 2049-9493 Woodhead Publishing Series in Biomaterials (online)
The publisher’s policy is to use permanent paper from mills that operate a
sustainable forestry policy, and which has been manufactured from pulp which is
processed using acid-free and elemental chlorine-free practices. Furthermore, the
publisher ensures that the text paper and cover board used have met acceptable
environmental accreditation standards.
Typeset by Newgen Knowledge Works Pvt Ltd, India
Printed by Lightning Source
© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd iv 7/9/2013 2:24:09 PM
Contents
Contributor contact details xi
Woodhead Publishing Series in Biomaterials xv
Foreword xix
Introduction xxiii
Part I Methods for cell and tissue engineering 1
1 Fundamentals of cell and matrix biology for tissue
engineering 3
V. Salih, Plymouth University Schools of Medicine and
Dentistry, UK (formerly at UCL Eastman Dental Institute,
UK) and D. Thomas, UCL Eastman Dental Institute, UK
1.1 Introduction 3
1.2 Extracellular matrices (ECMs) 5
1.3 ECM and cell interaction 9
1.4 ECM and mechanical signalling 12
1.5 Future trends 13
1.6 Conclusion 14
1.7 References 14
2 Three-dimensional collagen biomatrix development
and control 18
U. Cheema, UCL Institute of Orthopaedics and
Musculoskeletal Science, UK
2.1 Engineering cell-rich and matrix-rich tissues using
collagen scaffolds 18
2.2 Controlling the mechanical properties of collagen 21
2.3 Architectural features: introducing elements of tissue
complexity 26
v
© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd v 7/9/2013 2:24:09 PM
vi Contents
2.4 Future trends 30
2.5 References 31
3 Two- and three-dimensional tissue culture
bioprocessing methods for soft tissue engineering 34
M. J. Ellis, University of Bath, UK
3.1 Introduction 34
3.2 Bioreactor confi gurations 35
3.3 Selecting scaffold materials and architectures for your
bioreactor 39
3.4 Mass transfer in tissue engineering bioreactors 43
3.5 Important parameters and taking measurements of
bioreactor cultures 45
3.6 Tissue engineering process design 46
3.7 Future trends 48
3.8 Conclusion 49
3.9 Sources of further information and advice 49
3.10 References 50
4 Two- and three-dimensional tissue culture methods
for hard tissue engineering 5 4
M. A. Birch and K. E. Wright, Newcastle University, UK
4.1 Introduction 54
4.2 Culture of bone and cartilage cells 56
4.3 Cell culture parameters: bone tissue culture 60
4.4 Cell culture parameters: cartilage tissue culture 64
4.5 Two-dimensional tissue culture methods for hard tissues 67
4.6 Two-and-a-half- and three-dimensional tissue culture
methods for hard tissues 68
4.7 Conclusion 71
4.8 References 71
5 Vascularisation of tissue-engineered constructs 77
B. Buranawat, P. Kalia and L. Di Silvio, King’s College
London, Dental Institute, UK
5.1 Introduction 77
5.2 Growth of healthy vessels – embryonic vasculogenesis 79
5.3 Angiogenic diseases 81
5.4 Angiogenesis and bone formation 83
© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd vi 7/9/2013 2:24:09 PM
Contents vii
5.5 Cell sources for vascular tissue engineering 91
5.6 Co-culture of cells: the interactions between angiogenesis
and osteogenesis 91
5.7 Strategies to induce i n vitro prevascularisation 92
5.8 Tubular formation 94
5.9 Conclusion 94
5.10 References 96
Part II Standards and protocols in cell and tissue engineering 105
6 Standards in cell and tissue engineering 107
P. Tomlins, Consultant, UK
6.1 Introduction 107
6.2 How and by whom are standards produced? 109
6.3 The importance of an agreed lexicon 109
6.4 Drivers for standardization 110
6.5 How will standards help me? 111
6.6 What standards currently exist in tissue engineering? 111
6.7 Characterization of biomaterials and biomolecules 112
6.8 Characterization of tissue scaffolds 112
6.9 Characterization of cell-seeded scaffolds 119
6.10 Manufacture, processing and storage 120
6.11 Characterization of cells and cell–surface interactions 121
6.12 Conclusion 122
6.13 References 123
7 Principles of good laboratory practice (GLP) for i n vitro
cell culture applications 127
B. Idowu and L. Di Silvio, King’s College London, Dental
Institute, UK
7.1 Introduction 127
7.2 GLP governing bodies 129
7.3 Resources required for GLP compliance 132
7.4 Characterisation 135
7.5 Standards and regulations 138
7.6 Documentation of results 141
7.7 Independent monitoring of research processes and quality
assurance (QA) personnel 142
7.8 Application of GLP to human cell culture systems 143
© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd vii 7/9/2013 2:24:09 PM
viii Contents
7.9 Conclusion 145
7.10 Acknowledgements 145
7.11 References 146
8 Quality control in cell and tissue engineering 148
I. B. Wall, University College London, UK and N. Davie,
University of Oxford, UK
8.1 Introduction 148
8.2 Quality control to ensure a well-defi ned cell therapy
product 151
8.3 Commercial quality control/quality assurance in large-scale
manufacture 157
8.4 Conclusion 162
8.5 References 162
9 Standardised chemical analysis and testing of
biomaterials 166
W. Chrzanowski and F. Dehghani, The University of
Sydney, Australia
9.1 Introduction: why we need standard methods for testing
biomaterials 166
9.2 Standardised chemical analysis: when and why we assess
chemistries 167
9.3 Chemical properties 168
9.4 Imaging methods for measuring porosity 173
9.5 Physical characterisation – permeability 178
9.6 Surface properties 179
9.7 Degradation and stability in physiological fl uids 181
9.8 Implant–tissue interface tests 184
9.9 Limitations of current standardised testing methods 193
9.10 References 194
10 Sterilisation procedures for tissue allografts 197
B. J. Parsons, Leeds Metropolitan University, UK
10.1 Introduction 197
10.2 Interaction of ionising radiation with matter 198
10.3 Sources of ionising radiation 202
10.4 Validation and international standards of sterilisation by
ionising radiation 204
© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd viii 7/9/2013 2:24:09 PM
Contents ix
10.5 Conclusions and future trends 210
10.6 Sources of further information and advice 210
10.7 References 210
11 Commercial manufacture of cell therapies 212
I. B. Wall, University College London, UK and
D. A. Brindley, University of Oxford, UK and Harvard
University, USA
11.1 Introduction: cells as therapies 212
11.2 The transition from laboratory to commercial-scale
manufacture of cell therapies 220
11.3 Key regulatory requirements for commercial manufacture
of cell therapies 225
11.4 Cell-based therapy versus monoclonal antibody therapies:
lessons from existing biopharmaceutical manufacture 230
11.5 Conclusion 235
11.6 References 235
Index 241
© Woodhead Publishing Limited, 2013
00_pi-xxvi.indd ix 7/9/2013 2:24:10 PM