New analytical methods for the assessment of the physical stability of therapeutical proteins:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Abschlussarbeit Buch |
| Sprache: | English |
| Veröffentlicht: |
München
Verl. Dr. Hut
2013
|
| Ausgabe: | 1. Aufl. |
| Schriftenreihe: | Pharmazeutische Technologie
|
| Schlagworte: | |
| Online-Zugang: | kostenfrei https://nbn-resolving.org/urn:nbn:de:bvb:19-156542 kostenfrei Inhaltsverzeichnis |
| Beschreibung: | 151 S. graph. Darst. 210 mm x 148 mm, 261 g |
| ISBN: | 9783843909853 3843909857 |
Internformat
MARC
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| 100 | 1 | |a Spalthoff, Veronika Maria |d 1980- |e Verfasser |0 (DE-588)1035486350 |4 aut | |
| 245 | 1 | 0 | |a New analytical methods for the assessment of the physical stability of therapeutical proteins |c Veronika Maria Spalthoff |
| 250 | |a 1. Aufl. | ||
| 264 | 1 | |a München |b Verl. Dr. Hut |c 2013 | |
| 300 | |a 151 S. |b graph. Darst. |c 210 mm x 148 mm, 261 g | ||
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| 490 | 0 | |a Pharmazeutische Technologie | |
| 502 | |a München, Univ., Diss., 2013 | ||
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| 650 | 0 | 7 | |a Stabilität |0 (DE-588)4056693-6 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Heilmittel |0 (DE-588)4024069-1 |2 gnd |9 rswk-swf |
| 655 | 7 | |0 (DE-588)4113937-9 |a Hochschulschrift |2 gnd-content | |
| 689 | 0 | 0 | |a Proteine |0 (DE-588)4076388-2 |D s |
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Datensatz im Suchindex
| _version_ | 1806324985838436352 |
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| adam_text |
IMAGE 1
TABLE OF CONTENT
1. GENERAL INTRODUCTION AND OBJECTIVE OF THE THESIS 1
1.1 INTRODUCTION 1
1.2 PROTEIN INSTABILITY 2
1.2.1 CHEMICAL INSTABILITY 2
1.2.2 PHYSICAL INSTABILITY 3
1.2.3 FACTORS THAT AFFECT PROTEIN STABILITY 5
1.3 ANALYTICAL METHODS FOR STABILITY ASSESSMENT OF THERAPEUTICAL PROTEIN
FORMULATIONS 7
1.3.1 LIGHT SCATTERING 8
1.3.2 CHROMATOGRAPHY ^ 9
1.3.3 ANALYTICAL ULATRACENTRIFUGATION (AUC) 10
1.3.4 ASYMMETRICAL FLOW FIELD-FLOW FRACTIONATION (AF4) 11
1.3.5 PARTICLE COUNTING 12
1.3.5.1 LIGHT OBSCURATION 13
1.3.5.2 MICROSCOPIC PARTICLE COUNTING 13
1.3.5.3 MICROFLOW IMAGING (MFI) 14
1.3.5.4 ACCUSIZER FY NANO 15
1.3.5.5 ELECTRICAL SENSING ZONE 16
1.4 THE COMPENDIAL AND ANALYTICAL GAP 16
1.5 OBJECTIVE OF THE THESIS 20
1.6 REFERENCE LIST 22
2. MATERIAL AND METHODS 33
2.1 MATERIALS 33
2.1.1 THERAPEUTIC PROTEINS 33
2.1.1.1 IGGI-A AND IGGI-LI 33
2.1.1.2 GCSF 33
2.1.1.3 RPA 33
2.1.2 CHEMICALS AND REAGENTS 34
2.2 METHODS 35
HTTP://D-NB.INFO/1034377728
IMAGE 2
2.2.1 PROTEIN SAMPLE PROCESSING 35
2.2.1.1 SHAKING STRESS 35
2.2.1.2 STIRRING STRESS 35
2.2.1.3 THERMAL STRESS 36
2.2.1.4 FREEZE-THAWING 36
2.2.1.5 LYOPHILIZATION 37
2.2.2 PROTEIN AGGREGATE CHARACTERIZATION METHODS 38
2.2.2.1 PARTICLE COUNTING 38
2.2.2.1.1 PARTICLE COUNTING WITH ACCUSIZER FY NANO (AS) 38
2.2.2.1.2 CLASSICAL LIGHT OBSCURATION (LO) PARTICLE COUTING 39
2.2.2.1.3 MICROFLOW IMAGING (MFI) PARTICLE COUNTING 39
2.2.2.1.4 EVALUATION OF PARTICLE COUNTING MEASUREMENTS 40
2.2.2.2 MICROSCOPIC EXAMINATION 40
2.2.2.3 DYNAMIC LIGHT SCATTERING (DLS) 41
2.2.2.4 SIZE-EXCLUSION CHROMATOGRAPHY (SEC) 41
2.2.2.5 OPTICAL DENSITY AT 550 NM (OD) 42
2.2.3 OTHER METHODS 44
2.2.3.1 QUANTIFICATION OF PROTEIN ADSORPTION TO GLASS VIALS 44
2.2.3.2 DIFFERENTIAL SCANNING CALORIMETRY (DSC) 44
2.2.3.3 KARL-FISCHER TITRATION 44
2.2.3.4 ZETA POTENTIAL TITRATION 45
2.2.3.5 STRESS SIMULATIONS 45
2.3 REFERENCE LIST 47
3. RELEVANCE OF SUBMICRON PARTICLE COUNTING FOR DEVELOPMENT AND QUALITY
ASSURANCE OF PROTEIN PHARMACEUTICALS 49
3.1 INTRODUCTION 49
3.2 EXPERIMENTAL SETUP 53
3.3 RESULTS AND DISCUSSION 55
3.3.1 LIGHT OBSCURATION MEASUREMENTS WITH USP-QUALIFIED LO INSTRUMENTS
IN
COMPARISON TO AS 55
3.3.2 FOCUSED EXTINCTION AND AUTODILUTION OF AS 57
3.3.3 IS THE VERY EARLY ONSET OF AGGREGATION DETECTABLE WITH AS? 57
IMAGE 3
3.3.3.1 LOWER DETECTION LIMIT OF AS 57
3.3.3.2 ONSET OF AGGREGATION AND PARTICLE FORMATION 58
3.3.4 AGGREGATION THEORY 60
3.3.5 COMPARISON OF AS WITH DLS 63
3.3.6 COMPARISON OF AS WITH TURBIDITY MEASUREMENTS 66
3.3.7 COMPARISON OF AS WITH SEC 68
3.3.8 DOES MFI DELIVER EARLIER INFORMATION? 70
3.4 -CONCLUSION 73
3.5 REFERENCE LIST 75
4. DILUTION OF STRESSED PROTEIN SOLUTIONS INTO SERUM: EFFECTS ON
PARTICLE
COUNTING 79
4.1 INTRODUCTION 79
4.2 EXPERIMENTAL SETUP 80
4.3 RESULTS AND DISCUSSION 82
4.3.1 MECHANICAL STRESS AND DILUTION OF IGGI 82
4.3.2 FREEZE-THAWING AND DILUTION OF IGGI 83
4.3.3 MECHANICAL STRESS AND DILUTION OF GCSF 83
4.3.4 FREEZE-THAWING AND DILUTION OF GCSF 85
4.3.5 MECHANICAL STRESS AND DILUTION OF RPA 86
4.3.6 FREEZE-THAWING AND DILUTION OF RPA 88
4.3.7 THERMAL STRESS 90
4.3.8 KINETICS 92
4.4 CONCLUSION 93
4.5 REFERENCE LIST 95
5. BUFFER-SCREENING: EFFECTS OF DILUTION, PH AND STANDING TIME ON
PARTICULATE
MATTER IN IGGI-SOLUTION 99
5.1 INTRODUCTION 99
5.2 EXPERIMENTAL SETUP 100
5.3 RESULTS AND DISCUSSION 101
5.3.1 EXPERIMENT 1 101
IMAGE 4
5.3.1.1 RESULTS OF PARTICLE COUNTING: LO AND MFI 101
5.3.1.2 EFFECT OF DILUTION ON PH 103
5.3.1.3 DILUTION EFFECT ON PARTICULATE MATTER 103
5.3.1.4 ZETA POTENTIAL MEASUREMENTS 104
5.3.1.5 MICROSCOPIC RESULTS 107
5.3.2 EXPERIMENT 2 109
5.3.2.1 RESULTS OF PARTICLE COUNTING: LO AND MFI 109
5.4 CONCLUSION 111
5.5 REFERENCE LIST 113
6. COMPARISON OF TOPLYO (SCHOTT) VIALS WITH STANDARD GLASS TYPE I VIALS
CONCERNING REPRESSION OR ENHANCEMENT OF PARTICLE FORMATION 115
6.1 INTRODUCTION 115
6.2 SAMPLE PREPARATION AND EXPERIMENTAL SETUP 117
6.3 RESULTS AND DISCUSSION 118
6.3.1 PHYSICOCHEMICAL PROPERTIES OF LYOPHILIZATES 118
6.3.2 PARTICLE COUNTING AFTER FREEZE-DRYING IGGI-A 118
6.3.3 ZETA POTENTIAL 120
6.3.4 DESORPTION OF PROTEIN 120
6.4 CONCLUSION 123
6.5 REFERENCE LIST 124
7. SIMULATION OF STIR STRESS AND PREDICTION OF RESULTING PARTICLE
FORMATION IN
IGGI-SOLUTIONS 127
7.1 INTRODUCTION 127
7.2 EXPERIMENTAL SETUP 128
7.3 RESULTS AND DISCUSSION 129
7.3.1 SITUATION FOR PARTICLES 51 PM 129
7.3.2 SITUATION FOR PARTICLES 510 PM 132
7.3.3 UPSCALING EXPERIMENT 133
7.4 CONCLUSION 135
7.5 REFERENCE LIST 136
IMAGE 5
8. FINAL SUMMARY OF THE THESIS 139
8.1.1 RELEVANCE OF SUBMICRON PARTICLE COUNTING 139
8.1.2 PARTICULATE MATTER IN SERUM SOLUTIONS 141
8.1.3 EFFECTS OF DILUTION, PH AND STANDING TIME ON PARTICULATE MATTER
142
8.1.4 COMPARISON OF TOPLYO VIALS (SCHOTT) WITH STANDARD GLASS TYPE I
VIALS
142
8.1.5 STRESS SIMULATIONS 143
8.2 CONCLUSION 143
9. APPENDIX 145
9.1 OVERVIEW TABLES OF TIME POINTS OF FIRST DETECTION AFTER STRESSING
IGG-I-A 146
9.2 OVERVIEW TABLES OF TIME POINTS OF FIRST DETECTION AFTER STRESSING
IGGRLL 147
9.3 OVERVIEW TABLES OF TIME POINTS OF FIRST DETECTION AFTER STRESSING
GCSF 149
9.4 OVERVIEW TABLES OF TIME POINTS OF FIRST DETECTION AFTER STRESSING
RPA 150 |
| any_adam_object | 1 |
| author | Spalthoff, Veronika Maria 1980- |
| author_GND | (DE-588)1035486350 |
| author_facet | Spalthoff, Veronika Maria 1980- |
| author_role | aut |
| author_sort | Spalthoff, Veronika Maria 1980- |
| author_variant | v m s vm vms |
| building | Verbundindex |
| bvnumber | BV041074853 |
| collection | ebook |
| ctrlnum | (OCoLC)854723884 (DE-599)DNB1034377728 |
| dewey-full | 610 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610 |
| dewey-search | 610 |
| dewey-sort | 3610 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | 1. Aufl. |
| format | Thesis Book |
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| spelling | Spalthoff, Veronika Maria 1980- Verfasser (DE-588)1035486350 aut New analytical methods for the assessment of the physical stability of therapeutical proteins Veronika Maria Spalthoff 1. Aufl. München Verl. Dr. Hut 2013 151 S. graph. Darst. 210 mm x 148 mm, 261 g txt rdacontent n rdamedia nc rdacarrier Pharmazeutische Technologie München, Univ., Diss., 2013 Proteine (DE-588)4076388-2 gnd rswk-swf Stabilität (DE-588)4056693-6 gnd rswk-swf Heilmittel (DE-588)4024069-1 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Proteine (DE-588)4076388-2 s Stabilität (DE-588)4056693-6 s Heilmittel (DE-588)4024069-1 s DE-604 Erscheint auch als Online-Ausgabe urn:nbn:de:bvb:19-156542 X:MVB text/html http://deposit.dnb.de/cgi-bin/dokserv?id=4323043&prov=M&dok_var=1&dok_ext=htm Verlag kostenfrei Inhaltstext https://nbn-resolving.org/urn:nbn:de:bvb:19-156542 Resolving-System http://edoc.ub.uni-muenchen.de/15654/ Verlag kostenfrei Volltext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=026051756&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Spalthoff, Veronika Maria 1980- New analytical methods for the assessment of the physical stability of therapeutical proteins Proteine (DE-588)4076388-2 gnd Stabilität (DE-588)4056693-6 gnd Heilmittel (DE-588)4024069-1 gnd |
| subject_GND | (DE-588)4076388-2 (DE-588)4056693-6 (DE-588)4024069-1 (DE-588)4113937-9 |
| title | New analytical methods for the assessment of the physical stability of therapeutical proteins |
| title_auth | New analytical methods for the assessment of the physical stability of therapeutical proteins |
| title_exact_search | New analytical methods for the assessment of the physical stability of therapeutical proteins |
| title_full | New analytical methods for the assessment of the physical stability of therapeutical proteins Veronika Maria Spalthoff |
| title_fullStr | New analytical methods for the assessment of the physical stability of therapeutical proteins Veronika Maria Spalthoff |
| title_full_unstemmed | New analytical methods for the assessment of the physical stability of therapeutical proteins Veronika Maria Spalthoff |
| title_short | New analytical methods for the assessment of the physical stability of therapeutical proteins |
| title_sort | new analytical methods for the assessment of the physical stability of therapeutical proteins |
| topic | Proteine (DE-588)4076388-2 gnd Stabilität (DE-588)4056693-6 gnd Heilmittel (DE-588)4024069-1 gnd |
| topic_facet | Proteine Stabilität Heilmittel Hochschulschrift |
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