Antibodies: Volume 1: Production and Purification PDF
Preview Antibodies: Volume 1: Production and Purification
ANTIBODIES VOLUME 1: PRODUCTION AND PURIFICATION ANTIBODIES VOLUME 1: PRODUCTION AND PURIFICATION Edited by G. Subramanian Littleboume. Kent. United Kingdom Springer Science+Business Media, LLC Library of Congress Cataloging-in-Publication Data Antibodies / edited by G. Subramanian. p.; cm. Includes bibliographical references and index. Contents: v. 1. Production and purification - v. 2. Novel technologies and therapeutic use. ISBN 978-1-4613-4701-9 ISBN 978-1-4419-8875-1 (eBook) DOI 10.1007/978-1-4419-8875-1 1. Monoclonal antibodies--Synthesis. 2. Monoclonal antibodies--Therapeutic use. 3. Monoclonal antibodies-Biotechnology. 1. Subramanian, G., 1935- [DNLM: 1. Antibodies, Monoclonal--isolation & purification. 2. Antibodies, Monoclonal--therapeutic use. 3. Biotechnology--methods. 4. Chromatography-methods. QW 575.5.A6 A6283 2004] TP248.65.M65A55 2004 615'.37--dc22 2003069160 ©2004 Springer Science+Business Media New York Originally pub1ished by K1uwer Academic / P1enum Pub1ishers in 2004 Softcover reprint of the hardcover lst edition 2004 Ali rights reserved No pari of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanica1, photocopying, microfilming, recording, or otherwise, without written permission from the Publisher, with the exception of any material supplied specifical1y for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work .. Permissions for books published in Europe: [email protected] Permissions for books published in the United States of America: [email protected] Preface In the last century since the technology was developed for producing monoclonal antibodies, numerous methods have been applied to their purification. Prominent examples include ion exchange chromatography, hydrophobic interaction chromatography, protein A affinity chromato graphy, hydroxyapatite chromatography and others. Even among this small subset, virtually none of the methods have been exploited to their full potential and some havebeenoverlookedalmostentirely, all to the detriment ofthe industry. Also, all methods have weaknesses, some very serious and many critical limitations have been overlooked, likewise to the detriment of the industry. Meanwhile product applications have become steadily more sophisticated and demanding, regulatory agencies have become more knowledgeable and assertive and the place ofmarket development continues to exert ever greaterpressurefor rapidtime tomarket. Ifthe antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continueto emerge. This book presents an overview of the current advances applied in the manufactureofmonoclonal antibody. I am indebted to the international group ofcontributors who have come forward to share their practical knowledge and experience. Each chapter represents an overview of its chosen topics. Chapter one presents the concepts in development of manufacturing strategies for monoclonal antibodies. Importance ofantibody fragments and the methods ofproduction have been presented in chapter two. Application ofchromatographymethod development in production and purification is discussed in the subsequent three chapters. Chapter six discusses the qualitycontrol aspect ofantibodies. v VI Preface The effect ofexpression on the antibody properties is presented in chapter seven. Removal ofvirus andits safety in antibody production isdiscussed in chapter eight. The next two chapters cover the aspects of contract manufacturing and the pharmacokinetics and pharmacodynamic consider ation for monoclonal antibodies. The regulatory aspect in the manufacture oftherapeutic antibody isdocumentedinthelastchapter. Mythanks to allthecontributors fortheirenthusiasm andpatience during theproduction ofthebook. It is to be hoped that this book willbe ofgreat value to all ofthose who are actively working in the field of antibodies and that it will stimulate further progress and advancement in this field to meet the ever increasing demands in theproduct. I should be most grateful for any suggestion, which could servetoimprove futureeditions ofthebook. My deep appreciation to Jo Lawrence of Kluwer AcademiclPlenum publishers forher continuoushelp throughout thisproject. G. Subramanian Contributors DominiqueBourel Department ofResearchand Development LFB Biotechnologies 3,Avenuedes Tropiques B.P.305, Les VIis F- 91958 Courtaboeufcedex France Malcolm K. Brattle Q-OneBiotechLtd. Todd Campus West ofScotlandSciencePark Glasgow, G20 OXA UK John Bray Q-OneBiotechLtd. Todd Campus West ofScotlandSciencePark Glasgow,G20 OXA UK Christophede Romeuf DepartmentofResearchand Development LFB Biotechnologies 3,Avenuedes Tropique B.P 305, Les VIis F- 91958 Courtaboeufcedex France vii Vlll Contributors Brendan Fish DownstreamProcessingDepartment CambridgeAntibodyTechnology MilsteinBuilding GrantaPark Cambridge, CBI 6GH UK MatthiasFrech MerckKgaA Life Science Products FrankfurterStrasse 250 64293 Darmstadt Germany Ruth Freitag Chairfor BioprocessTechnology UniversityofBayreuth D-95440 Bayreuth Germany ChristineGaucher DepartmentofResearch and Development LFB Biotechnologies 3,Avenuedes Tropiques B.P.305 LesVIis F-91958 Courtaboeufcedex France Arnaud Glacet DepartmentofResearchand Development LFB Biotechnologies 3,Avenuedes Tropiques B.P. 305 Les VIis F- 91958 Courtaboeufcedex France DavidJ. Glover GlaxoSmithKline South Eden Park Road Beckenham Kent,BR3 3BS UK Contributors IX David B.Haughey PrevalereLife SciencesInc. I HalseyRoad Whitesboro N.Y.l3492 USA AndreasHermann CardionAG Erkrath Germany DavidP. Humphreys Celltech R&D Ltd 208 BathRoad Slough Berkshire, SLl 3WE UK LotharR. Jacob MerckKgaA Life ScienceProducts Frankfurter Strasse 250 64293 Darmstadt Germany Paula M.Jardieu Prevalere Life Sciences Inc. I HalseyRoad Whitesboro N.Y.l3492 USA SylvieJorieux DepartmentofResearchand Development LFB Biotechnologies 3Avenuedes Tropiques B.P.305 Les Ulis F-91958 Courtaboeufcedex France MarkJostameling Newlab BioqualityAG Max-Planck-Strasse 15A x Contributors D-40699Erkrath Germany GlenwynKemp Millipore (UK) Ltd No 1.IndustrialEstate MedomsleyRoad Consett CountyDurham DH86SZ UK PhilippeKlein DepartmentofResearchand Development LFB Biotechnologies 3, Avenuedes Tropiques B.P.305 Les Ulis F- 91958 Courtaboeufcedex France Kerstin Muller NewlabBioqualityAG Max-Planck-Strasse 15A D-40699 Erkrath Germany PaulO'Neil Euroflow (UK) Ltd. 8 EltonAvenue Stratham NH03885 USA Martin Pitshke EvotecTechnologiesGmbH Erkrath Germany AndreasRichter Newlab BioqualityAG Max-Planck-Strasse 15A D-40699Erkrath Germany Contributors Xl LincolnTsang OfCounsel Arnold& Porter Tower42 25 Old BroadStreet London, EC2N IRQ UK Leo A.van DerPol DSM Biologics CompanyBV Zuiderweg72/2 P.O.Box454 9700 AL Groningen The Netherlands CarolineVandevyver LaboratoryofChemical Biotechnology FacultyofBasic Science Swiss Federal Institute ofTechnology Lausanne Switzerland DouweF. Westra DSM BiologicsCompanyBV Zuiderweg72/2 P.O.Box454 9700 AL Groningen The Netherlands
Description:The list of books you might like
