Bioanalysis of vinca-alkaloids and monoclonal antibodies

276 Pages·2009·9.39 MB·English

Bioanalysis of vinca-alkaloids and monoclonal antibodies
Challenges associated with the analysis of small and large molecules
ISBN/EAN: 978-90-393-5058-0
© 2009, Carola Damen, Amsterdam
Cover Design: Patricia Damen-Verkerk en Carola Damen, Amsterdam,
The Netherlands
With special thanks to Mr. F. Beer for his help with the photography.
Pictures cover page and chapter separation pages: trastuzumab under polarized light
microscopy.
Printed by: Gildeprint Drukkerijen B.V., Enschede, The Netherlands
Bioanalysis of vinca-alkaloids and monoclonal antibodies
Challenges associated with the analysis of small and large molecules
Bioanalyse van vinca-alkaloïden en monoclonale antilichamen
Uitdagingen gerelateerd aan de analyse van kleine en grote moleculen
(met een samenvatting in het Nederlands)
PROEFSCHRIFT
ter verkrijging van de graad van doctor
aan de Universiteit Utrecht
op gezag van de rector magnificus, prof. dr. J.C. Stoof,
ingevolge het besluit van het college voor promoties
in het openbaar te verdedigen
op woensdag 1 juli 2009 des middags te 4.15 uur
door
Carola Wilhelmina Nicolette Damen
geboren op 12 december 1977
te Breda
Promotoren:
Prof. dr. J.H. Beijnen
Prof. dr. J.H.M. Schellens
Co-promotor:
Dr. H. Rosing
The research described in this thesis was performed at:
The Department of Pharmacy & Pharmacology, Slotervaart Hospital / The
Netherlands Cancer Institute, Amsterdam, The Netherlands
&
The Department of Immunopathology Research and the Department of Diagnostic
Services, Sanquin, Amsterdam, The Netherlands
Printing of this thesis was financially supported by:
Bayer Schering Pharma, Mijdrecht, The Netherlands
Boehringer Ingelheim bv, Alkmaar, The Netherlands
Eli Lilly Nederland BV, Houten, The Netherlands
J.E. Jurriaanse Stichting, Rotterdam, The Netherlands
Merck Sharp & Dohme BV, Haarlem, The Netherlands
Pfizer bv, Capelle aan den Ijssel, The Netherlands
Roche Nederland B.V., Woerden, The Netherlands
Shimadzu Benelux, ‘s-Hertogenbosch, The Netherlands
Stichting Netherlands Laboratory for Anticancer Drug Formulation (NLADF),
Amsterdam, The Netherlands
Waters Corporation, Milford, MA, USA

Je kunt je als een dame gedragen,
je wordt echter alleen als Damen geboren
Contents
Chapter 1 Preface 11
Chapter 2 The bioanalysis of vinca-alkaloids
2.1 High-performance liquid chromatography coupled with 17
mass spectrometry for the quantitative analysis of vinca-
alkaloids in biological matrices: a concise survey from the
literature
2.2 A sensitive assay for the quantitative analysis of vinorelbine 35
in mouse and human EDTA plasma by high performance
liquid chromatography coupled with electrospray tandem
mass spectrometry
2.3 The bioanalysis of vinorelbine and 4-O-deacetylvinorelbine 55
in human and mouse plasma using high-performance liquid
chromatography coupled with heated electrospray ionization
tandem mass spectrometry
2.4 Validated assay for the simultaneous quantification of 75
total vincristine and actinomycin-D concentrations in
human EDTA plasma and of vincristine concentrations
in human plasma ultrafiltrate by high-performance liquid
chromatography coupled with tandem mass spectrometry
2.5 Application of dried blood spots combined with high- 101
performance liquid chromatography coupled with
electrospray tandem mass spectrometry for the simultaneous
quantification of vincristine and actinomycin-D
Chapter 3 Structural characterization of monoclonal antibodies
3.1 Electrospray ionization quadrupole ion-mobility time-of- 121
flight mass spectrometry as tool to distinguish the lot-to-lot
heterogeneity in N-glycosylation profile the therapeutic
monoclonal antibody trastuzumab
Chapter 4 The quantification of monoclonal antibodies
4.1 Bioanalytical methods for the quantification of therapeutic 147
monoclonal antibodies and their application in clinical
pharmacokinetic studies
4.2 Quantitative aspects of the analysis of the monoclonal 187
antibody trastuzumab using high-performance liquid
chromatography coupled with electrospray mass
spectrometry
4.3 The bioanalysis of the monoclonal antibody trastuzumab by 201
high-performance liquid chromatography with fluorescence
detection after immuno-affinity purification from human
serum
4.4 Development and validation of an enzyme-linked 217
immunosorbent assay for the quantification of trastuzumab
in human serum and plasma
4.5 The bioanalysis of trastuzumab in human serum using 233
precipitate-enhanced ellipsometry
Chapter 5 Conclusions and Perspectives 247
Summary 253
Samenvatting 258
Samenvatting voor niet-ingewijden 265
Dankwoord 269
Curriculum Vitae 273
List of publications related to this thesis 274