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Analytical Techniques for Biopharmaceutical Development
Copyright © 2005 by Marcel Dekker.
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Copyright © 2005 by Marcel Dekker.
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Although great care has been taken to provide accurate and current information, neither the author(s)
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. The material contained
herein is not intended to provide specific advice or recommendations for any specific situation.
Trademark notice: Product or corporate names may be trademarks or registered trademarks and are
used only for identification and explanation without intent to infringe.
Library of Congress Cataloging-in-Publication Data
Analytical techniques for biopharmaceutical development / Tim Wehr, Roberto Rodriguez-
Diaz, Stephen Tuck, editors.
p. ; cm.
Includes bibliographical references and index.
ISBN 0-8247-2667-7 (alk. paper)
1. Protein drugs--Analysis--Laboratory manuals.
[DNLM: 1. Pharmaceutical Preparations--analysis--Laboratory Manuals. 2.
Biopharmaceutics--methods--Laboratory Manuals. 3. Chromatography--methods--Laboratory
Manuals. 4. Electrophoresis--methods--Laboratory Manuals. 5. Spectrum Analysis--
methods--Laboratory Manuals. QV 25 A5338 2005] I. Wehr, Tim. II. Rodríguez-Díaz,
Roberto. III. Tuck, Stephen (Stephen F.)
RS431.P75A536 2005
615'.7--dc22
2004058292
ISBN: 0-8247-0706-0
This book is printed on acid-free paper.
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Marcel Dekker, 270 Madison Avenue, New York, NY 10016, U.S.A.
tel: 212-696-9000; fax: 212-685-4540
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Copyright © 2005 by Marcel Dekker. All Rights Reserved.
Neither this book nor any part may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying, microfilming, and recording, or by any information
storage and retrieval system, without permission in writing from the publisher.
Current printing (last digit):
10987654321
PRINTED IN THE UNITED STATES OF AMERICA
Copyright © 2005 by Marcel Dekker.
Contents
About the Editors
vii
Contributors
ix
1. Analytical Techniques for Biopharmaceutical Development
1
Stephen Tuck
2. Introduction to the Development of Biopharmaceuticals
5
Roberto Rodriguez-Diaz
3. Protein Assay
13
Stephen Tuck and Rowena Ng
4. Use of Reversed-Phase Liquid Chromatography
in Biopharmaceutical Development
27
Tim Wehr
5. Practical Strategies for Protein Contaminant Detection
by High-Performance Ion-Exchange Chromatography
67
Pete Gagnon
6. Practical Strategies for Protein Contaminant Detection
by High-Performance Hydrophobic Interaction Chromatography
81
Pete Gagnon
v
Copyright © 2005 by Marcel Dekker.
vi
Contents
7. Use of Size Exclusion Chromatography
in Biopharmaceutical Development
95
Tim Wehr and Roberto Rodriguez-Diaz
8. Slab Gel Electrophoresis for Protein Analysis
113
David E. Garfin
9. Capillary Electrophoresis of Biopharmaceutical Proteins
161
Roberto Rodriguez-Diaz, Stephen Tuck, Rowena Ng,
Fiona Haycock, Tim Wehr, and Mingde Zhu
10. Mass Spectrometry for Biopharmaceutical Development
227
Alain Balland and Claudia Jochheim
11. Analytical Techniques for Biopharmaceutical
Development — ELISA
279
Joanne Rose Layshock
12. Applications of NMR Spectroscopy in Biopharmaceutical
Product Development
305
Yung-Hsiang Kao, Ping Wong, and Martin Vanderlaan
13. Microcalorimetric Approaches to Biopharmaceutical Development
327
Richard L. Remmele, Jr.
14. Vibrational Spectroscopy in Bioprocess Monitoring
383
Emil W. Ciurczak
Copyright © 2005 by Marcel Dekker.

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