Stability and characterization of protein and peptide drugs: case histories
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York u.a.
Plenum Press
1993
|
| Schriftenreihe: | Pharmaceutical biotechnology
5 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXI, 353 S. Ill., graph. Darst. |
| ISBN: | 0306443651 |
Internformat
MARC
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Datensatz im Suchindex
| _version_ | 1804123956753465344 |
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| adam_text | STABILITY AND CHARACTERIZATION OF PROTEIN AND PEPTIDE DRUGS CASE
HISTORIES EDITED BY Y. JOHN WANG SCIOS NOVA, INC. MOUNTAIN VIEW,
CALIFORNIA AND RODNEY PEARLMAN GENENTECH, INC. SOUTH SAN FRANCISCO,
CALIFORNIA PLENUM PRESS * NEW YORK AND LONDON CONTENTS CHAPTER 1
STABILITY AND CHARACTERIZATION OF HUMAN GROWTH HORMONE RODNEY PEARLMAN
AND THOMAS A. BEWLEY 1. INTRODUCTION 1 1.1. HISTORY OF HGH AND HGH
PREPARATIONS 1 1.2. CLINICAL USE OF HGH 3 1.3. STRUCTURE AND PROPERTIES
OF PITUITARY AND RECOMBINANT HGH 5 2. ANALYTICAL CHARACTERIZATION 9 2.1.
SPECTROSCOPY 10 2.2. ELECTROPHORESIS 16 2.3. IMMUNOASSAYS 18 2.4.
BIOASSAYS 19 2.5. CHROMATOGRAPHIC METHODS 20 3. DEGRADATION PATHWAYS 26
3.1. DEAMIDATION 27 3.2. OXIDATION 29 3.3. REDUCTION/INTERCHANGE OF
DISULFIDE BONDS 31 3.4. AGGREGATION 36 3.5. PROTEOLYSIS/HYDROLYSIS 40
3.6. SHEAR 42 4. STABILITY PROFILE OF HGH 43 4.1. SOLUTION STABILITY 43
4.2. STABILITY IN THE SOLID STATE 45 5. FORMULATIONS 47 6. CONCLUSIONS
48 REFERENCES 50 XV J CONTENTS CHAPTER 2 CHARACTERIZATION AND
FORMULATION CONSIDERATIONS FOR RECOMBINANTLY DERIVED BOVINE SOMATOTROPIN
STEPHEN R. DAVIO AND MICHAEL J. HAGEMAN 1. INTRODUCTION 59 1.1. BST
COMMERCIAL APPLICATIONS 59 1.2. BST PRIMARY STRUCTURE 59 1.3. RBST
PRODUCTION 61 1.4. BST PREDICTED CONFORMATIONAL STRUCTURE 61 2. RBST
STRUCTURAL CHARACTERIZATION 62 2.1. RBST PRIMARY STRUCTURE (SEQUENCE) 62
2.2. RBST SECONDARY STRUCTURE 67 2.3. RBST TERTIARY STRUCTURE 69 2.4.
RBST QUATERNARY STRUCTURE 70 2.5. RBST BIOASSAY CHARACTERIZATION 71 3.
RBST CONFORMATIONAL STABILITY 72 3.1. THE EFFECT OF SOLUTION PH ON RBST
CONFORMATION 72 3.2. THE EFFECT OF DENATURANTS ON RBST CONFORMATION 73
4. RBST PHYSICAL PROPERTIES 74 4.1. SOLUBILITY PROPERTIES 74 4.2.
DISSOLUTION PROPERTIES 77 5. PHYSICAL/CHEMICAL STABILITY 78 5.1.
SOLUTION STABILITY 78 5.2. SOLID-STATE STABILITY 81 5.3. ABSORPTION OF
WATER IN THE SOLID STATE 82 6. FORMULATIONS 82 REFERENCES 84 CHAPTER 3
STABILITY CHARACTERIZATION AND FORMULATION DEVELOPMENT OF ALTEPLASE, A
RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR TUE H. NGUYEN AND CAROLE WARD
1. INTRODUCTION 91 1.1. THE FIBRINOLYTIC SYSTEM 92 1.2. TISSUE
PLASMINOGEN ACTIVATOR 92 1.3. PHARMACOLOGY AND CLINICAL USE OF ALTEPLASE
93 2. STRUCTURE AND PROPERTIES OF ALTEPLASE 94 2.1. PRIMARY STRUCTURE 94
CONTENTS XVII 2.2. CARBOHYDRATE COMPOSITION 96 2.3. SOLUBILITY BEHAVIOR
97 3. ANALYTICAL CHARACTERIZATION 99 3.1. SPECTROSCOPY 100 3.2.
ELECTROPHORESIS 107 3.3. CHROMOGENIC ENZYMATIC ASSAY 109 3.4. CLOT LYSIS
ASSAY ILL 3.5. HPLC 113 4. STABILITY OF ALTEPLASE 118 4.1. DIFFERENTIAL
SCANNING CALORIMETRY STUDIES 118 4.2. STABILITY IN SOLUTION 120 4.3.
STABILITY OF ALTEPLASE IN THE LYOPHILIZED STATE (ACTIVASE) 126 5.
CONCLUSIONS 128 REFERENCES 129 CHAPTER 4 ORTHOCLONE OKT3: CHEMICAL
MECHANISMS AND FUNCTIONAL EFFECTS OF DEGRADATION OF A THERAPEUTIC
MONOCLONAL ANTIBODY PATRICIA E. RAO AND DANIEL J. KROON 1. BACKGROUND
135 1.1. HISTORY OFCLINICAL USE OF OKT3 135 1.2. BASIC BIOCHEMICAL
STRUCTURE OF OKT3 136 1.3. DISCOVERY OF OKT3 HYBRIDOMA AND IN VITRO
FUNCTIONAL EFFECTS 138 2. BIOLOGICAL EFFECTS OF DEGRADATION OF OKT3 139
2.1. EFFECTS ON BINDING AFFINITY 139 2.2. ABILITY TO INDUCE MITOGENESIS
140 2.3. ABILITY TO INHIBIT MLR 141 3. BIOCHEMICAL EVIDENCE OF
DEGRADATION 142 3.1. SHIFTS IN IEF PATTERN 143 3.2. ALTERATION IN
HPLC-IEC RETENTION TIMES 144 3.3. PROTEIN CHAIN ALTERATIONS DETECTED BY
SDS-PAGE 145 4. PRELIMINARY STUDIES OF DEGRADATION MECHANISMS 147 5.
IDENTIFICATION OF DEGRADATION SITES BY PEPTIDE MAPPING 148 5.1. PEPTIDE
MAPPING METHOD 148 5.2. SITES OF DEAMIDATION 150 5.3. POTENTIAL SITES OF
OXIDATIVE DEGRADATION 152 5.4. FORMATION OF INTERCHAIN CROSS-LINKS 153
6. CONCLUSION 155 REFERENCES 156 XVIII CONTENTS CHAPTER 5 LEUPROLIDE AND
OTHER LH-RH ANALOGUES AKWETE LEX ADJEI AND L. HSU 1. INTRODUCTION 159
1.1. PHARMACOLOGY OF LH-RH 159 1.2. LEUPROLIDE ACETATE AND OTHER LH-RH
ANALOGUES 160 1.3. CHEMISTRY AND STRUCTURAL PROPERTIES OF LH-RH
ANALOGUES .. 161 1.4. ANALYTICAL CHARACTERIZATION 169 1.5. PHYSICAL
PHARMACY OF LEUPROLIDE ACETATE 177 1.6. BIOANALYSIS 184 2. FORMULATIONS
AND DOSIMETRY 185 2.1. PARENTERAL PRODUCT FORMS 186 2.2. NASAL DOSAGE
FORMS 186 2.3. INHALATION DOSAGE FORMS 187 3. PRECLINICAL AND CLINICAL
STUDIES WITH LEUPROLIDE ACETATE 188 3.1. PHARMACOKINETICS FOLLOWING
ACUTE ADMINISTRATION 188 3.2. PHARMACODYNAMICS FOLLOWING CHRONIC
ADMINISTRATION 190 4. STABILITY STUDIES AND DEGRADATION KINETICS 191
4.1. DRUG SUBSTANCE STABILITY 192 4.2. FORMULATION STABILITY 193 4.3.
SHELF-LIFE PROJECTIONS 193 5. CONCLUSIONS 194 6. APPENDIX: SCHEMATIC
REPRESENTATION OF ION-PAIR PARTITION MODEL 195 REFERENCES 196 CHAPTER 6
STABILITY OF ADRENOCORTICOTROPIC HORMONE (ACTH) AND PATHWAYS OF
DEAMIDATION OF ASPARAGINYL RESIDUE IN HEXAPEPTIDE SEGMENTS KAMLESH PATEL
1. INTRODUCTION 201 1.1. PHARMACOLOGY 201 1.2. CLINICAL USE 202 1.3.
STRUCTURE AND PHYSICOCHEMICAL PROPERTIES 202 1.4. PREPARATIONS AND
ROUTES OF ADMINISTRATION 203 2. CHEMICAL STABILITY 203 2.1. DEAMIDATION
OF ACTH 203 2.2. DEAMIDATION OF ACTH 22 27 207 CONTENTS XIX 3.
CONCLUSIONS 218 REFERENCES 218 CHAPTER 7 STABILITY AND CHARACTERIZATION
OF HUMAN INTERLEUKIN-1/S LEO GU AND JODI FAUSNAUGH 1. INTRODUCTION 221
1.1. PREPARATION OF RECOMBINANT HIL-1/3 222 1.2. PHARMACOLOGY EVALUATION
AND CLINICAL APPLICATIONS 224 2. STRUCTURAL CHARACTERIZATION AND
ANALYTICAL METHODS 225 2.1. SPECTROSCOPY 225 2.2. AMINO ACID ANALYSIS
225 2.3. SEQUENCE ANALYSIS 226 2.4. SECONDARY AND TERTIARY STRUCTURAL
ANALYSIS 228 2.5. CHROMATOGRAPHIC AND ELECTROPHORETIC METHODS 230 2.6.
BIOASSAYS 232 2.7. IMMUNOASSAYS 234 3. PHYSICOCHEMICAL STABILITY 235
3.1. UNFOLDING AND REFOLDING OF RHIL-1/3 235 3.2. FREEZE-THAW EFFECT 235
3.3. AGGREGATION AND PRECIPITATION 237 3.4. STABILITY AT OR BELOW 30C
240 4. RHIL-1/3 FORMULATION AND ITS STABILITY 241 REFERENCES 245 CHAPTER
8 DEVELOPMENT AND SHELF-LIFE DETERMINATION OF RECOMBINANT INTERLEUKIN-2
(PROLEUKIN) JOHN GEIGERT, NICHOLAS SOLLI, PEGGY WOEHLEKE, AND SHRAM
VEMURI 1. THE IL-2 MOLECULE 249 2. THE IL-2 MANUFACTURING PROCESS 251
2.1. SYNTHESIS 251 2.2. RECOVERY 251 2.3. PURIFICATION 252 2.4.
FORMULATING AND FINISHING 253 3. STABILITY-INDICATING TEST METHODS 253
3.1. METHODS FOR IL-2 253 3.2. METHODS FOR PROLEUKIN 255 XX CONTENTS 4.
PROLEUKIN STABILITY 257 5. STABILITY UPON RECONSTITUTION 259 REFERENCES
261 CHAPTER 9 FORMULATION AND STABILITY OF RECOMBINANT A,-ANTITRYPSIN
SRIRAM VEMURI, C. TONY YU, AND NIEK ROOSDORP 1. INTRODUCTION 263 2.
OVERVIEW OF THE MANUFACTURING PROCESS 265 3. ANALYTICAL METHODS 265 3.1.
DETERMINATION OF MONOMERIC RAAT CONTENT 265 3.2. DETERMINATION OF RAAT
ACTIVITY 266 3.3. DETERMINATION OF TOTAL RAAT PROTEIN 266 3.4.
DETERMINATION OF TOTAL NITROGEN 267 4. PREFORMULATION STUDIES 267 4.1.
EFFECT OF PH ON RAAT SOLUTION STABILITY 267 4.2. EFFECT OF POTASSIUM
CHLORIDE ON RAAT SOLUTION STABILITY .... 268 4.3. EFFECT OF IONIC
STRENGTH ON RAAT SOLUTION STABILITY 269 4.4. EFFECT OF CITRATE ON RAAT
SOLUTION STABILITY 270 4.5. PHYSICAL STABILITY OF RAAT SOLUTION 271 5.
FORMULATION DEVELOPMENT 277 5.1. SOLUTION STABILITY SCREENING 277 5.2.
LYOPHILIZATION 279 6. CONCLUSION 284 REFERENCES 285 CHAPTER 10
FIBROLASE: A FIBRINOLYTIC PROTEIN FROM SNAKE VENOM DENISE PRETZER,
BRENDA S. SCHULTEIS, CHRISTOPHER D. SMITH, DAVID G. VANDER VELDE, JAMES
W. MITCHELL, AND MARK C. MANNING 1. INTRODUCTION 287 2. PHYSICAL
PROPERTIES 289 3. ANALYTICAL METHODS 290 3.1. PROTEOLYTIC ACTIVITY WITH
OXIDIZED INSULIN B CHAIN AS A SUBSTRATE 290 3.2. PROTEOLYTIC ACTIVITY
ASSAY WITH AZOCASEIN AS A SUBSTRATE 291 3.3. CIRCULAR DICHROISM
MEASUREMENTS 291 CONTENTS XXI 3.4. NUCLEAR MAGNETIC RESONANCE
MEASUREMENTS 291 3.5. ELECTROPHORESIS AND PROTEIN QUANTITATION 292 4.
EFFECT OF PH ON FIBROLASE STABILITY 292 5. STABILITY OF FIBROLASE AND
TEMPERATURE EFFECTS 298 6. EFFECTS OF ZINC BINDING ON THE STABILITY AND
STRUCTURE OF FIBROLASE 305 6.1. EFFECTS OF EDTA ADDITION 305 6.2.
PROPOSED ZINC BINDING SITE 309 7. SUMMARY 311 REFERENCES 312 CHAPTER 11
INSULIN STRUCTURE AND STABILITY JENS BRANGE AND LOTTE LANGKJCER 1.
INTRODUCTION 315 2. INSULIN STRUCTURE 316 2.1. PRIMARY STRUCTURE 316
2.2. SECONDARY AND TERTIARY STRUCTURE 316 2.3. QUATERNARY STRUCTURE
(SELF-ASSOCIATION) 317 2.4. STRUCTURE IN PHARMACEUTICAL FORMULATIONS 320
2.5. STABILITY OVERVIEW 321 3. PHYSICAL STABILITY 322 3.1. ISOELECTRIC
AND METAL-ION-INDUCED PRECIPITATION 322 3.2. FIBRILLATION 322 3.3.
ADSORPTION PHENOMENA 324 3.4. INFLUENCE OF INSULIN SPECIES AND PURITY
324 3.5. PHYSICAL STABILITY OF PHARMACEUTICAL FORMULATIONS 325 4.
CHEMICAL STABILITY 327 4.1. INTRODUCTION 327 4.2. FORMATION OF
HYDROLYSIS PRODUCTS 328 4.3. DI- AND POLYMERIZATION 332 4.4. INFLUENCE
OF PH AND AUXILIARY SUBSTANCES 334 4.5. EFFECT OF TEMPERATURE 334 4.6.
KINETICS AND MECHANISMS 336 4.7. PROPERTIES OF TRANSFORMATION PRODUCTS
340 4.8. INFLUENCE ON THE QUALITY OF PHARMACEUTICAL PREPARATIONS * 340
5. SUMMARY AND CONCLUSIONS 342 REFERENCES 344 INDEX 351
|
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| id | DE-604.BV009617440 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T17:38:01Z |
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| isbn | 0306443651 |
| language | English |
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| publishDate | 1993 |
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| publisher | Plenum Press |
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| series | Pharmaceutical biotechnology |
| series2 | Pharmaceutical biotechnology |
| spelling | Stability and characterization of protein and peptide drugs case histories ed. by Y. John Wang ... New York u.a. Plenum Press 1993 XXI, 353 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Pharmaceutical biotechnology 5 Eiwitten gtt Geneesmiddelen gtt Stabiliteit gtt Drug Stability Peptide drugs Stability Peptides chemistry Peptides pharmacokinetics Protein drugs Stability Proteins chemistry Proteins pharmacokinetics Peptide (DE-588)4045125-2 gnd rswk-swf Proteine (DE-588)4076388-2 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Arzneimittelstabilität (DE-588)4122835-2 gnd rswk-swf Peptide (DE-588)4045125-2 s Arzneimittel (DE-588)4003115-9 s Arzneimittelstabilität (DE-588)4122835-2 s DE-604 Proteine (DE-588)4076388-2 s Wang, Y. J. Sonstige oth Pharmaceutical biotechnology 5 (DE-604)BV007730074 5 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=006355847&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Stability and characterization of protein and peptide drugs case histories Pharmaceutical biotechnology Eiwitten gtt Geneesmiddelen gtt Stabiliteit gtt Drug Stability Peptide drugs Stability Peptides chemistry Peptides pharmacokinetics Protein drugs Stability Proteins chemistry Proteins pharmacokinetics Peptide (DE-588)4045125-2 gnd Proteine (DE-588)4076388-2 gnd Arzneimittel (DE-588)4003115-9 gnd Arzneimittelstabilität (DE-588)4122835-2 gnd |
| subject_GND | (DE-588)4045125-2 (DE-588)4076388-2 (DE-588)4003115-9 (DE-588)4122835-2 |
| title | Stability and characterization of protein and peptide drugs case histories |
| title_auth | Stability and characterization of protein and peptide drugs case histories |
| title_exact_search | Stability and characterization of protein and peptide drugs case histories |
| title_full | Stability and characterization of protein and peptide drugs case histories ed. by Y. John Wang ... |
| title_fullStr | Stability and characterization of protein and peptide drugs case histories ed. by Y. John Wang ... |
| title_full_unstemmed | Stability and characterization of protein and peptide drugs case histories ed. by Y. John Wang ... |
| title_short | Stability and characterization of protein and peptide drugs |
| title_sort | stability and characterization of protein and peptide drugs case histories |
| title_sub | case histories |
| topic | Eiwitten gtt Geneesmiddelen gtt Stabiliteit gtt Drug Stability Peptide drugs Stability Peptides chemistry Peptides pharmacokinetics Protein drugs Stability Proteins chemistry Proteins pharmacokinetics Peptide (DE-588)4045125-2 gnd Proteine (DE-588)4076388-2 gnd Arzneimittel (DE-588)4003115-9 gnd Arzneimittelstabilität (DE-588)4122835-2 gnd |
| topic_facet | Eiwitten Geneesmiddelen Stabiliteit Drug Stability Peptide drugs Stability Peptides chemistry Peptides pharmacokinetics Protein drugs Stability Proteins chemistry Proteins pharmacokinetics Peptide Proteine Arzneimittel Arzneimittelstabilität |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=006355847&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV007730074 |
| work_keys_str_mv | AT wangyj stabilityandcharacterizationofproteinandpeptidedrugscasehistories |