Antibodies: Volume 1: Production and Purification

319 Pages·2004·17.56 MB·English

by  Brendan Fish (auth.)

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
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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