Protein adsorption to vial surfaces: quantification, structural and mechanistic studies
Saved in:
| Main Author: | |
|---|---|
| Format: | Thesis Book |
| Language: | English |
| Published: |
Göttingen
Cuvillier
2010
|
| Edition: | 1. Aufl. |
| Subjects: | |
| Online Access: | Volltext https://nbn-resolving.org/urn:nbn:de:bvb:19-121255 Inhaltsverzeichnis |
| Physical Description: | 237 S. Ill., graph. Darst. 21 cm |
| ISBN: | 9783869554815 |
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MARC
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| 245 | 1 | 0 | |a Protein adsorption to vial surfaces |b quantification, structural and mechanistic studies |c Johannes Maximilian Mathes |
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| 264 | 1 | |a Göttingen |b Cuvillier |c 2010 | |
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Record in the Search Index
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| adam_text | IMAGE 1
TABLE OF CONTENTS
CHAPTER 1
INTRODUCTION AND OBJECTIVES OF THE THESIS
1 INTRODUCTION 2
1.1 ADSORPTION OF THERAPEUTIC PROTEINS ON SOLID SURFACES 2
1.2 RECOMBINANT PROTEINS AND THEIR FORMULATION 3
1.3 IMMUNOGENICITY OF PROTEINS 4
1.4 GLASS - A PRIMARY PACKAGING MATERIAL FOR PARENTERAL DOSAGE FORMS 4
1.5 SURFACE MODIFICATIONS OF GLASS CONTAINERS FOR PARENTERAL
PHARMACEUTICALS 5
1.6 PROTEIN ADSORPTION AT THE SOLID LIQUID INTERFACE 6
1.7 FACTORS INFLUENCING THE ADSORPTION OF THERAPEUTIC PROTEINS ON SOLID
SURFACES 9
1.8 CHARACTERIZATION OF PROTEIN ADSORPTION ON SOLID SURFACES 11
2 OBJECTIVES OF THE THESIS 13
3 REFERENCES 14
CHAPTER 2
DEVELOPMENT OF SENSITIVE METHODS FOR THE QUANTIFICATION OF PROTEIN
ADSORPTION TO PHARMACEUTICAL CONTAINERS
1 INTRODUCTION 22
2 MATERIALS AND METHODS 25
2.1 MATERIALS - 25
2.1.1 PROTEIN FORMULATION * 25
2.1.2 GLASS VIALS AND CLOSURE SYSTEMS - 25
2.1.3 CHEMICALS / EXCIPIENTS. * * 25
2.1.4 TEST TUBES * ~ 26
2.2 METHODS _ 26
2.2.1 SE-HPLC ~ ~ 26
2.2.2 UV SPECTROSCOPY _ ~ - 26
BIBLIOGRAFISCHE INFORMATIONEN HTTP://D-NB.INFO/1007311827
DIGITALISIERT DURCH
IMAGE 2
2.2.3 FLUORESCENCE SPECTROSCOPY 26
2.2.4 MICRO BCA PROTEIN ASSAY KIT 27
2.2.5 CALBIOCHEM NON INTERFERING PROTEIN ASSAY 27
2.2.6 ANALYSIS OF TOTAL ORGANIC CARBON 27
2.2.7 SURFACE TENSION MEASUREMENTS 28
3 RESULTS AND DISCUSSION 28
3.1 DEVELOPMENT AND OPTIMIZATION OF A STANDARDIZED QUANTIFICATION METHOD
28
3.1.1 DETERMINATION OF FLUORESCENCE PROPERTIESOFLGGL ANDH-IGG 28
3.1.2 VALIDATION OF A NEW SE-HPLC METHOD FOR SENSITIVE IGG
QUANTIFICATION 30 3.1.3 VALIDATION OF A NEW TOTAL ORGANIC CARBON
ANALYSIS METHOD FOR SENSITIVE IGG QUANTIFICATION 33
3.1.4 SENSITIVITY OF THE NEW METHODS IN COMPARISON WITH COMMERCIAL
STANDARD ASSAYS 36
3.2 DEVELOPMENT OF A STANDARDIZED IGG ADSORPTION QUANTIFICATION ASSAY
FOR GLASS CONTAINERS 38
3.2.1 DESORPTION BUFFER AND TIMEFRAME OF DESORPTION PROCESS 38
3.2.2 RINSING BUFFER AND NUMBER OF RINSING STEPS 39
3.2.3 TIMEFRAME OF ADSORPTION PROCESS 41
3.3 IGGL ADSORPTION ON GLASS VIALS - COMPARISON OF SE-HPLC AND TOC
METHOD 43
4 CONCLUSIONS 44
5 REFERENCES 45
CHAPTER 3
INFLUENCE OF VIAL SURFACE PROPERTIES ON IGGL ADSORPTION
1 INTRODUCTION 50
2 MATERIALS AND METHODS 55
2.1 MATERIALS 55
2.1.1 PROTEIN FORMULATION 55
2.1.2 GLASS VIALS AND CLOSURE SYSTEMS _ 55
2.1.3 CHEMICALS / EXCIPIENTS 56
2.2 METHODS 56
2.2.1 ARGON CORONA DISCHARGE PLASMA TREATMENT OF GLASS SURFACES 56 2.2.2
CONTACT ANGLE MEASUREMENTS 57
2.2.3 UV SPECTROSCOPY * 57
Z2.4 ADSORPTION METHOD 58
2.2.5 SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY 58
IMAGE 3
2.2.6 TIME OF FLIGHT SECONDARY ION MAESS SPECTROMETRY. 58
3 RESULTS AND DISCUSSION 59
3.1 INFLUENCE OF SURFACE FREE ENERGY ON IGGL ADSORPTION 59
3.2 PERSISTENCE OF PLASMA-MEDIATED SURFACE HYDROPHILICITY AND RELATED
IGGL
ADSORPTION PROPERTIES AFTER VIAL STORAGE 68
3.3 TENSIOMETRIC INVESTIGATION OF PROTEIN-COVERED GLASS SURFACE 69
3.4 INFLUENCE OF PH ON GLASS PROPERTIES AFFECTING IGGL ADSORPTION 71
3.4.1 INFLUENCE OF PH ON THE ELEMENTAL GLASS COMPOSITION 73
3.4.2 INFLUENCE OF PH ON THE GLASS SURFACE FREE ENERGY 76
4 CONCLUSIONS 79
5 REFERENCES 80
CHAPTER 4
INFLUENCE OF THE PROTEIN FORMULATION ON IGG ADSORPTION TO VIALS
1 INTRODUCTION 84
2 MATERIALS AND METHODS 87
2.1 MATERIALS 87
2.1.1 PROTEIN FORMULATION 87
2.1.2 GLASS VIALS AND CLOSURE SYSTEMS 88
2.1.3 GLASS POWDER 88
2.1.4 CHEMICALS / EXCIPIENTS 88
2.2 METHODS 89
2.2.1 CALCULATION OFLONIC STRENGTH 89
2.2.2 ISOELECTRIC FOCUSING 90
2.2.3 ELECTROPHORETIC MOBILITY MEASUREMENTS BY DYNAMIC LASER LIGHT
SCATTERING 90
2.2.4 DETERMINATION OF THE HYDRODYNAMIC DIAMETER BY DYNAMIC LASER LIGHT
SCATTERING 90
2.2.5 UV SPECTROSCOPY 91
2.2.6 ADSORPTION PROCESS 91
2.2.7 SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY 91
3 RESULTS AND DISCUSSION 92
3.1 INFLUENCE OF CHARGE ON IGG ADSORPTION - FORMULATION PARAMETERS PH
AND
IONIC STRENSTH * ~ * 92
3.1.1 CHARGE CHARACTERIZATION OF IGG AND GLASS SURFACE 92
3.1.2 IMPACT OF THE FORMULATION PH ON IGG ADSORPTION * 95
IMAGE 4
3.1.2.1 THEADSORBEDQUANTITYASAFUNCTIONOFPH 95
3.1.2.2 ELECTROSTATIC INTERACTIONS WITHIN THE ADSORPTION INTERFACE 99
3.1.3 IMPACT OF THE FORMULATION IONIC STRENGTH ON IGG ADSORPTION 102
3.1.4 IGGL MONOMER SIZE AS A FUNCTION OF PH AND IONIC STRENGTH 106
3.1.5 DISCUSSION OF OTHER DRIVING FORCES AND INFLUENCING FACTORS 107
3.2 INFLUENCE OF FORMULATION EXCIPIENTS INDUDING HOFMEISTER
CONSIDERATIONS 109
3.2.1 INFLUENCE OF THE IONIC STRENGTH-DETERMINING SALT TYPE 109
3.2.2 INFLUENCE OF SUGARS AND POLYOLS 112
3.2.3 INFLUENCE OF SURFACTANTS 114
CONCLUSIONS 118
REFERENCES 120
CHAPTER 5
MODELING OF IGGL ADSORPTION TO VIALS - ISOTHERM CONSIDERATIONS AND
AFFINITY ASPECTS
1 INTRODUCTION 128
2 MATERIALS AND METHODS 131
2.1 MATERIALS 131
2.1.1 PROTEIN FORMULATION 131
2.1.2 GLASS VIALS AND CLOSURE SYSTEMS 131
2.1.3 CHEMICALS / EXCIPIENTS 131
2.2 METHODS 132
2.2.1 UV SPECTROSCOPY 132
2.2.2 ADSORPTION PROCESS FOR ISOTHERM DETERMINATION 132
2.2.3 SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY 132 2.2.4
(NON-) LINEAR CURVE FITTING 133
2.2.5 QUARTZ CRYSTAL MICROBALANCE MEASUREMENTS 133
3 RESULTS AND DISCUSSION 134
3.1 FITTING OF IGGL ADSORPTION ISOTHERMS DETERMINED ON BOROSILICATE
GLASS 134
3.2 QCM KINETIC MEASUREMENTS OF IGGL ADSORPTION 138
3.3 ISOTHERMS OF IGGL ADSORPTION ON DIFFERENT CONTAINER SURFACES 139
4 CONCLUSIONS. *.. 143
5 REFERENCES 144
IMAGE 5
CHAPTER 6
ADVANCED INVESTIGATIONS ON ADSORBED IGGL MOLECULES WITH XPS AND TOF-SIMS
1 INTRODUCTION 148
2 MATERIALS AND METHODS 151
2.1 MATERIALS 151
2.1.1 PROTEIN FORMULATION 151
2.1.2 CHEMICALS / EXCIPIENTS 151
2.1.3 GLASS PREPARATION 151
2.2 METHODS 152
2.2.1 X-RAY PHOTOELECTRON SPECTROSCOPY 152
2.2.2 TIME OF FLIGHT SECONDARY ION MASS SPECTROMETRY. 152
2.2.3 ADSORPTION PROCESS AND SAMPLE PREPARATION 152
2.2.4 PRINCIPAL COMPONENT ANALYSIS 153
3 RESULTS AND DISCUSSION 153
3.1 XPS INVESTIGATIONS OF IGGL, BLANK GLASS VIALS AND IGGL ADSORBATES
153
3.2 TOF-SIMS INVESTIGATIONS OF IGGL, BLANK GLASS, AND IGGL ADSORBATES
161
4 CONCLUSIONS 172
5 REFERENCES 173
C H A P T ER 7
STRUCTURAL STABILITY INVESTIGATIONS AND ATOMIC FORCE MICROSCOPY IMAGING
OF
IGGL ADSORBED ON BOROSILICATE GLASS
1 INTRODUCTION 178
2 MATERIALS AND METHODS 180
2.1 MATERIALS 180
2.1.1 PROTEIN FORMULATION AND INCLUDING EXCIPIENTS 180
2.1.2 GLASS POWDER 180
2.1.3 GLASS VIALS / GLASS VIAL BOTTOMS 181
2.2 METHODS 181
2.2.1 STATIC LASER LIGHT SCATTERING * 181
2.2.2 SCANNING ELECTRON MICROSCOPY (SEM) * _ 181
IMAGE 6
2.2.3 SPECIFIE SURFACE AREA ANALYSIS 182
2.2.4 ADSORPTION PROCESS 182
2.2.5 UV SPECTROSCOPY 183
2.2.6 SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (SE-HPLC)
183 2.2.7 FLUORESCENCE SPECTROSCOPY 184
2.2.8 FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) 185
2.2.9 ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) 185
2.2.10 SODIUM DODECYL SULFATE POLYACRYLAMIDE GELELECTROPHORESIS
(SDS-PAGE) 186 2.2.11 ATOMIC FORCE MICROSCOPY (AFM) 186
3 RESULTS AND DISCUSSION 187
3.1 PHYSICAL CHARACTERIZATION OF GLASS PARTICLES 187
3.2 ADSORPTION STUDIES OF IGGL ON GLASS PARTICLES - DIFFERENCES BETWEEN
VIAL AND PARTIDE SURFACE 190
3.3 IGG STABILITY AND STRUCTURAL STUDIES 192
3.3.1 STABUEITY STUDIES ON IGGL 192
3.3.1.1 SDS-PAGE 193
3.3.1.2 SE-HPLC 193
3.3.1.3 INTRINSIC AND EXTRINSIC STEADY STATE FLUORESCENCE 195
3.3.1.4 FT-IR 198
3.3.2 STRUCTURAL INVESTIGATIONS OF IGGL DIRECTLY ON THE SURFACE OF GLASS
PARTICLES 201 3.3.2.1 SECONDARY STRUCTURE (FT-IR) 201
3.3.2.2 TERTIARY STRUCTURE (INTRINSIC AND EXTRINSIC STEADY STATE
FLUORESCENCE) 203 3.3.3 STRUCTURAL STUDIES ON DESORBED IGGL 204
3.3.3.1 SDS-PAGE OF SURFACTANT-DESORBED IGGL 205
3.3.3.2 AGGREGATION / FRAGMENTATION (SE-HPLC) OF PH-DESORBED IGGL 206
3.3.3.3 SECONDARY STRUCTURE (FT-IR) OF PH-DESORBED IGGL 207
3.3.3.4 TERTIARY STRUCTURE (INTRINSIC AND EXTRINSIC STEADY STATE
FLUORESCENCE) OF PH-DESORBED IGGL 208
3.3.3.5 BIOLOGICAL ACTIVITY AND STRUCTURAL INTEGRITY OF PH-DESORBED
H-IGG 210
3.4 ATOMIC FORCE MICROSCOPY INVESTIGATIONS ON GLASS VIAL BOTTOMS 212
4 CONCLUSIONS 221
5 REFERENCES 222
CHAPTER 8
SUMMARYOFTHETHESIS 229
IMAGE 7
APPENDIX
LIST OF ABBREVIATIONS 233
CURRICULUM VITAE 237
|
| any_adam_object | 1 |
| author | Mathes, Johannes Maximilian 1979- |
| author_GND | (DE-588)142590711 |
| author_facet | Mathes, Johannes Maximilian 1979- |
| author_role | aut |
| author_sort | Mathes, Johannes Maximilian 1979- |
| author_variant | j m m jm jmm |
| building | Verbundindex |
| bvnumber | BV036770101 |
| collection | ebook |
| ctrlnum | (OCoLC)690910001 (DE-599)DNB1007311827 |
| dewey-full | 615.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.19 |
| dewey-search | 615.19 |
| dewey-sort | 3615.19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | 1. Aufl. |
| format | Thesis Book |
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| oclc_num | 690910001 |
| open_access_boolean | 1 |
| owner | DE-12 DE-384 DE-473 DE-BY-UBG DE-703 DE-1051 DE-824 DE-29 DE-91 DE-BY-TUM DE-19 DE-BY-UBM DE-1049 DE-92 DE-739 DE-898 DE-BY-UBR DE-355 DE-BY-UBR DE-706 DE-20 DE-1102 DE-29T |
| owner_facet | DE-12 DE-384 DE-473 DE-BY-UBG DE-703 DE-1051 DE-824 DE-29 DE-91 DE-BY-TUM DE-19 DE-BY-UBM DE-1049 DE-92 DE-739 DE-898 DE-BY-UBR DE-355 DE-BY-UBR DE-706 DE-20 DE-1102 DE-29T |
| physical | 237 S. Ill., graph. Darst. 21 cm |
| psigel | ebook |
| publishDate | 2010 |
| publishDateSearch | 2010 |
| publishDateSort | 2010 |
| publisher | Cuvillier |
| record_format | marc |
| spelling | Mathes, Johannes Maximilian 1979- Verfasser (DE-588)142590711 aut Protein adsorption to vial surfaces quantification, structural and mechanistic studies Johannes Maximilian Mathes 1. Aufl. Göttingen Cuvillier 2010 237 S. Ill., graph. Darst. 21 cm txt rdacontent n rdamedia nc rdacarrier Zugl.: München, Univ., Diss., 2010 Immunglobulin G (DE-588)4127637-1 gnd rswk-swf Rekombinantes Protein (DE-588)4277353-2 gnd rswk-swf Adsorption (DE-588)4000536-7 gnd rswk-swf Proteinpräparat (DE-588)4247384-6 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Immunglobulin G (DE-588)4127637-1 s Adsorption (DE-588)4000536-7 s Proteinpräparat (DE-588)4247384-6 s Rekombinantes Protein (DE-588)4277353-2 s Pharmazeutische Technologie (DE-588)4045699-7 s DE-604 Erscheint auch als Online-Ausgabe urn:nbn:de:bvb:19-121255 http://edoc.ub.uni-muenchen.de/12125/ Verlag kostenfrei Volltext https://nbn-resolving.org/urn:nbn:de:bvb:19-121255 Resolving-System DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=020686978&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Mathes, Johannes Maximilian 1979- Protein adsorption to vial surfaces quantification, structural and mechanistic studies Immunglobulin G (DE-588)4127637-1 gnd Rekombinantes Protein (DE-588)4277353-2 gnd Adsorption (DE-588)4000536-7 gnd Proteinpräparat (DE-588)4247384-6 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| subject_GND | (DE-588)4127637-1 (DE-588)4277353-2 (DE-588)4000536-7 (DE-588)4247384-6 (DE-588)4045699-7 (DE-588)4113937-9 |
| title | Protein adsorption to vial surfaces quantification, structural and mechanistic studies |
| title_auth | Protein adsorption to vial surfaces quantification, structural and mechanistic studies |
| title_exact_search | Protein adsorption to vial surfaces quantification, structural and mechanistic studies |
| title_full | Protein adsorption to vial surfaces quantification, structural and mechanistic studies Johannes Maximilian Mathes |
| title_fullStr | Protein adsorption to vial surfaces quantification, structural and mechanistic studies Johannes Maximilian Mathes |
| title_full_unstemmed | Protein adsorption to vial surfaces quantification, structural and mechanistic studies Johannes Maximilian Mathes |
| title_short | Protein adsorption to vial surfaces |
| title_sort | protein adsorption to vial surfaces quantification structural and mechanistic studies |
| title_sub | quantification, structural and mechanistic studies |
| topic | Immunglobulin G (DE-588)4127637-1 gnd Rekombinantes Protein (DE-588)4277353-2 gnd Adsorption (DE-588)4000536-7 gnd Proteinpräparat (DE-588)4247384-6 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| topic_facet | Immunglobulin G Rekombinantes Protein Adsorption Proteinpräparat Pharmazeutische Technologie Hochschulschrift |
| url | http://edoc.ub.uni-muenchen.de/12125/ https://nbn-resolving.org/urn:nbn:de:bvb:19-121255 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=020686978&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT mathesjohannesmaximilian proteinadsorptiontovialsurfacesquantificationstructuralandmechanisticstudies |