Formulation, characterization, and stability of protein drugs: case histories
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Plenum Press
1996
|
| Schriftenreihe: | Pharmaceutical biotechnology
9 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXVIII, 432 S. Ill., graph. Darst. |
| ISBN: | 0306453320 |
Internformat
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| 245 | 1 | 0 | |a Formulation, characterization, and stability of protein drugs |b case histories |c ed. by Rodney Pearlman ... |
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| 490 | 1 | |a Pharmaceutical biotechnology |v 9 | |
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| adam_text | FORMULATION, CHARACTERIZATION, AND STABILITY OF PROTEIN DRUGS CASE
HISTORIES EDITED BY RODNEY PEARLMAN MEGABIOS CORPORATION V BURLINGAME,
CALIFORNIA I * AND Y. JOHN WANG SCIOS NOVA, INC. MOUNTAIN VIEW,
CALIFORNIA PLENUM PRESS * NEW YORK AND LONDON CONTENTS CHAPTER 1 A
COMPENDIUM AND HYDROPATHY/FLEXIBILITY ANALYSIS OF COMMON REACTIVE SITES
IN PROTEINS: REACTIVITY AT ASN, ASP, GIN, AND MET MOTIFS IN NEUTRAL PH
SOLUTION MICHAEL F. POWELL 1. INTRODUCTION 1 2. PREDICTION OF PROTEIN
CHEMICAL REACTIVITY BASED ON AMINO ACID SEQUENCE ANALYSIS 3 2.1. COMMON
CHEMICAL DEGRADATION PATHWAYS IN PROTEINS 4 2.2. CALCULATION OF PROTEIN
HYDROPATHY AND FLEXIBILITY 9 3. SUMMARY OF PROTEIN STABILITY IN AQUEOUS
SOLUTION 11 ADRENOCORTICOTROPIN (ACTH) 12 AGGLUTININ 13 ALDOLASE 14
AMYLIN ANTAGONIST 15 AMYLOID-RELATED SERUM PROTEIN (ARSP) 16 ANGIOGENIN
17 ANTI-HER-2 HEAVY CHAIN 18 ANTI-HER-2 LIGHT CHAIN 20 ANTIBODY 4D5
HEAVY CHAIN 21 ANTIBODY 4D5 LIGHT CHAIN 23 ANTIBODY 17-1A HEAVY CHAIN 24
ANTIBODY 17-1A LIGHT CHAIN 26 ANTIBODY E25 LIGHT CHAIN 27 ANTIBODY E25
HEAVY CHAIN 28 ANTIBODY LIGHT CHAIN-K (MOUSE) 30 ANTIBODY OKT3 HEAVY
CHAIN 31 ANTIBODY OKT3 LIGHT CHAIN 32 ANTIBODY OKT4A HEAVY CHAIN
(HUMANIZED) 34 ANTIBODY OKT4A LIGHT CHAIN (HUMANIZED) 35 XIX CONTENTS
ATRIAL NATRIURETIC PEPTIDE (ANP) (HUMAN) 36 BRAIN-DERIVED NEUROTROPHIC
FACTOR (BDNF) (HUMAN) 37 CALBINDIN (BOVINE) 38 CALMODULIN 39 CARBONIC
ANHYDRASE C 40 CD4 (HUMAN) 42 CD4-IGG 43 CD4-PE40 45 CHLOROPEROXIDASE
(CALDARIOMYCES FUMAGO) 48 CHOLERA B SUBUNIT PROTEIN (VIBRIO CHOLERAE) 49
CILIARY NEUROTROPHIC FACTOR (CNTF) (HUMAN) 50 CRYSTALLIN-A (CHICKEN) 51
CYTOCHROME C 53 DNASE (HUMAN) 55 EPIDERMAL GROWTH FACTOR (EGF 1-48)
(HUMAN) 56 EPIDERMAL GROWTH FACTOR (MURINE) 57 ERYTHROCYTE PROTEIN 4.1
(HUMAN) 58 FIBROBLAST GROWTH FACTOR, ACIDIC (HUMAN) (AFGF) 59 FIBROBLAST
GROWTH FACTOR, BASIC (HUMAN) (BFGF) 61 GLUCAGON 62 GRANULOCYTE-COLONY
STIMULATING FACTOR (G-CSF) (HUMAN) 63 GROWTH HORMONE (BOVINE) 64 GROWTH
HORMONE (HUMAN) 66 GROWTH HORMONE (PORCINE) 68 GROWTH HORMONE RELEASING
FACTOR (GHRF) VARIANT (HUMAN) 69 HEMOGLOBIN (HUMAN) 70 HIRUDIN 71
HISTONE 73 HYPOXANTHINE-GUANINE PHOSPHORIBOSYLTRANSFERASE (HXGT) 74
INSULIN (HUMAN) 75 INSULIN-LIKE GROWTH FACTOR-I (IGF-I) 76
INSULINOTROPIN 78 INTERFERON-ALPHA-2B (HUMAN) (IFN-A-2B) 79
INTERFERON-BETA (IFN-P) 80 INTERFERON-GAMMA (HUMAN) (7-IFN) 81
INTERLEUKIN-1 RECEPTOR ANTAGONIST (IL-1RA) 82 INTERLEUKIN-LA (IL-LA) 84
INTERLEUKIN-1 P (HUMAN) (IL-1(3) 85 INTERLEUKIN-1 P (MURINE) 86
INTERLEUKIN-2 (IL-2) 88 INTERLEUKIN-11 (HUMAN) 90 LUNG SURFACTANT SP-C
(HUMAN) 91 LYSOZYME (HEN EGG WHITE) 92 CONTENTS XXI MYELIN BASIC PROTEIN
(MBP) 93 NEOCARZINOSTATIN 94 NERVE GROWTH FACTOR (HUMAN) (NGF) 95
PARATHYROID HORMONE 97 RELAXIN 98 RIBONUCLEASE A (RNASE A) 99
RIBONUCLEASE U2 (RNASE U2) (USTILAGO SPHAEROGENA) 100 SECRETIN 101
SERINE HYDROXYMETHYLTRANSFERASE (SHMT) (RABBIT) 102 TISSUE FACTOR-243
104 TGF-BETA 106 THROMBOPOIETIN (TPO) 107 TISSUE PLASMINOGEN ACTIVATOR
(HUMAN) (T-PA) 108 TRYPSIN (BOVINE) 109 VEGF ILL 4. STATISTICAL ANALYSIS
OF PROTEIN DEGRADATION SITES IN AQUEOUS SOLUTION . . 112 5. GENERAL
CONCLUSIONS REGARDING PROTEIN DEGRADATION IN AQUEOUS SOLUTION 118
REFERENCES 134 CHAPTER 2 CHARACTERIZATION, STABILITY, AND FORMULATIONS
OF BASIC FIBROBLAST GROWTH FACTOR Y. JOHN WANG, ZAHRA SHAHROKH, SRIRAM
VEMURI, GERT EBERLEIN, IRINA BEYLIN, AND MARK BUSCH 1. INTRODUCTION 141
2. PHYSICOCHEMICAL CHARACTERIZATION AND ANALYSIS 144 2.1. STRUCTURE AND
THE CONFORMATION 144 2.2. UV SPECTROSCOPY 145 2.3. FLUORESCENCE
SPECTROSCOPY 146 2.4. CIRCULAR DICHROISM (CD) AND FOURIER-TRANSFORM
INFRARED SPECTROSCOPY (FTIR) 148 2.5. REVERSE-PHASE HPLC (RP-HPLC) 149
2.6. ION-EXCHANGE HPLC (HPIEC) 149 2.7. AFFINITY HPLC METHODS 150 2.8.
SIZE-EXCLUSION HPLC (HP-SEC) 150 3. BIOLOGICAL METHODS OF EVALUATION 151
3.1. CELL PROLIFERATION ASSAYS 151 3.2. IN VIVO ANIMAL MODELS 151 4.
THERMAL STABILITY 153 XXII CONTENTS 4.1. USE OF A DIFFERENTIAL SCANNING
CALORIMETER 153 4.2. THERMAL STABILITY AS A FUNCTION OF PH 153 4.3.
EFFECT OF SULFATED LIGAND 154 4.4. THERMAL STABILITY DETERMINED BY
CIRCULAR DICHROISM 155 5. OXIDATION OF CYSTEINES 156 5.1. DISULFIDE
FORMATION 156 5.2. PREVENTION OF CYSTEINE OXIDATION 158 5.3. SITES OF
CYSTEINE OXIDATION 158 6. COVALENT BOND MODIFICATION DETECTED BY HPIEC
159 6.1. MONOMER-MULTIMER DISTRIBUTION 159 6.2. IDENTIFICATION OF ASP 28
-PRO CLEAVED AND ASP 15 -GLY CLEAVED BFGF 160 6.3. IDENTIFICATION OF
SUCCINIMIDE AT ASPARTATE 15 163 7. AGGREGATION DETERMINED BY UV
SPECTROMETRY 164 7.1. EFFECT OF PH AND BUFFER TYPE 164 7.2. EFFECT OF
EXCIPIENTS 165 7.3. EFFECT OF SULFATED LIGANDS 167 8. CHARACTERIZATION
OF BFGF AGGREGATES AND PRECIPITATES 167 8.1. ABSENCE OF SOLUBLE
AGGREGATES 167 8.2. QUANTITATION OF INSOLUBLE AGGREGATES/PRECIPITATES
168 8.3. MASS BALANCE 169 8.4. CHARACTERIZATION OF PRECIPITATES 169 8.5.
AGGREGATION IN THE PRESENCE OF GLYCOSAMINOGLYCAN 170 9. FORMULATIONS 173
9.1. AQUEOUS SOLUTION 173 9.2. FREEZE-DRIED FORMULATION 173 9.3. POWDER
FORMULATION 174 9.4. MICROSPHERES 174 9.5. GEL FORMATION 175 9.6. TARGET
TO FGF RECEPTOR 176 10. CONCLUSION 176 REFERENCES 177 CHAPTER 3 THE
CHARACTERIZATION, STABILIZATION, AND FORMULATION OF ACIDIC FIBROBLAST
GROWTH FACTOR DAVID B. VOLKIN AND C. RUSSELL MIDDAUGH 1. INTRODUCTION
181 2. NATURE OF THE INTERACTION OF AFGF WITH HEPARIN 183 CONTENTS XXIII
2.1. CONFORMATIONAL STABILITY: THERMAL- AND DENATURANT-INDUCED UNFOLDING
OF AFGF IN THE PRESENCE AND ABSENCE OF HEPARIN 184 2.2. SIZE AND CHARGE
REQUIREMENTS OF HEPARIN REQUIRED TO STABILIZE AFGF 188 2.3.
STOICHIOMETRY AND AFFINITY OF THE AFGF-HEPARIN INTERACTION 189 3. NATURE
OF THE AFGF POLYANION BINDING SITE 192 3.1. SPECIFICITY OF THE AFGF
POLYANION BINDING SITE 192 3.2. INTERACTION OF AFGF WITH OTHER SELECTED
POLYANIONS: SURAMIN, SUCROSE OCTASULFATE, NUCLEOTIDES, AND
CHROMATOGRAPHY RESINS ... 194 3.3. STRUCTURE OF THE AFGF POLYANION
BINDING SITE 198 4. FORMULATION AND DELIVERY OF AFGF AS A WOUND-HEALING
AGENT 200 4.1. IN VITRO STABILITY CONSIDERATIONS: CONFORMATIONAL AND
CHEMICAL INTEGRITY OF AFGF 200 4.2. DELIVERY OF AFGF AS A TOPICAL AGENT
205 4.3. IN VIVO MOUSE MODEL STUDIES TO SUPPORT FORMULATION DEVELOPMENT
212 5. CONCLUSIONS 213 REFERENCES 214 CHAPTER 4 STABILITY,
CHARACTERIZATION, FORMULATION, AND DELIVERY SYSTEM DEVELOPMENT FOR
TRANSFORMING GROWTH FACTOR-BETA, WAYNE R. GOMBOTZ, SUSAN C. PANKEY, LISA
S. BOUCHARD, DUKE H. PHAN, AND ALAN P. MACKENZIE 1. INTRODUCTION 219
1.1. THE TGF-P FAMILY OF PROTEINS 219 1.2. IN VITRO ACTIVITIES OF TGF-3
220 1.3. IN VIVO ACTIVITIES OF TGF-P 221 1.4. POTENTIAL CLINICAL
APPLICATIONS 221 2. STRUCTURE AND PROPERTIES OF TGF- 3, 222 2.1. THE
TGF-P SUPERFAMILY 222 2.2. STRUCTURE 223 2.3. LATENCY 224 3. ANALYTICAL
CHARACTERIZATION 225 3.1. REVERSED-PHASE HIGH-PERFORMANCE LIQUID
CHROMATOGRAPHY (RP-HPLC) 225 3.2. SODIUM DODECYLSULFATE POLYACRYLAMIDE
GEL ELECTROPHORESIS (SDS-PAGE), NATIVE PAGE, AND WESTERN BLOT ANALYSIS
225 3.3. ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) 227 3.4. CELL GROWTH
INHIBITION ASSAY (GIA) 228 XXIV CONTENTS 3.5. CELL PROLIFERATION ASSAY
228 4. STABILITY OF TGF-P, 228 4.1. STABILITY IN SOLUTION 228 4.2.
PRELYOPHILIZATION STABILITY STUDIES 231 4.3. CONTAINER ADSORPTION STUDY
233 4.4. STABILITY IN THE LYOPHILIZED STATE 234 5. USE OF TGF-P, IN
CONTROLLED RELEASE SYSTEMS 239 5.1. BONE REGENERATION 239 5.2. DERMAL
WOUND HEALING 240 5.3. LOCALIZED DELIVERY TO GASTROINTESTINAL TRACT 240
6. CONCLUSIONS 241 REFERENCES 241 CHAPTER 5 STABILITY AND
CHARACTERIZATION OF RECOMBINANT HUMAN RELAXIN TUE H. NGUYEN AND STEVEN
J. SHIRE 1. BACKGROUND 247 1.1. ISOLATION AND PURIFICATION OF HUMAN
RELAXIN 247 1.2. PHARMACOLOGY AND PHARMACOKINETICS OF RELAXIN 248 2.
STRUCTURE AND PROPERTIES OF RECOMBINANT HUMAN RELAXIN 252 2.1. PRIMARY
STRUCTURE*PEPTIDE MAP 252 2.2. SECONDARY AND TERTIARY STRUCTURES 254
2.3. DIMERIZATION OF RECOMBINANT HUMAN RELAXIN 254 2.4. SOLUBILITY 258
3. STABILITY CHARACTERIZATION 259 3.1. ASSAY METHODOLOGY 259 3.2.
STABILITY IN SOLUTION 261 3.3. STABILITY IN METHYLCELLULOSE GEL 265 4.
CONCLUSIONS 270 REFERENCES 271 CHAPTER 6 INTERFERON-B-LB (BETASERON): A
MODEL FOR HYDROPHOBIC THERAPEUTIC PROTEINS LEO S. LIN, MICHAEL G.
KUNITANI, AND MANINDER S. HORA 1 . INTRODUCTION 275 2. MOLECULAR BIOLOGY
AND PROTEIN CHEMISTRY 276 3. PRECLINICAL AND CLINICAL APPLICATIONS OF
IFN-P 277 CONTENTS XXV 3.1. PRECLINICAL STUDIES 277 3.2. CLINICAL
STUDIES 280 4. PHYSICOCHEMICAL CHARACTERISTICS OF IFN-P 280 4.1. PRIMARY
STRUCTURE 280 4.2. SECONDARY AND TERTIARY STRUCTURES 284 5. ANALYTICAL
METHODS FOR EVALUATION OF PROTEIN PURITY 286 5.1. SDS-PAGE 286 5.2.
ISOELECTRIC FOCUSING (IEF) 287 5.3. RP-HPLC 288 6. IN VITRO BIOLOGICAL
ACTIVITY OF IFN-3 289 6.1. ANTIVIRAL YIELD REDUCTION ASSAY 289 6.2.
CYTOPATHIC EFFECT BIOASSAY 289 7. FORMULATION STUDIES 290 7.1.
SOLUBILITY ASPECTS 291 7.2. PARENTERAL FORMULATIONS OF IFN-P SER]7 294
7.3. LONG-ACTING FORMULATIONS OF IFN-P SERL7 294 8. STABILITY OF IFN-P
295 8.1. STABILITY-INDICATING ASSAYS 295 8.2. STABILITY OF IFN-P SERL7
296 9. CONCLUSIONS 297 REFERENCES 299 CHAPTER 7 CHARACTERIZATION,
FORMULATION, AND STABILITY OF NEUPOGEN (FILGRASTIM), A RECOMBINANT
HUMAN GRANULOCYTE-COLONY STIMULATING FACTOR ALAN C. HERMAN, THOMAS C.
BOONE, AND HSIENG S. LU 1. INTRODUCTION 303 1.1. CLINICAL USES OF
GRANULOCYTE-COLONY STIMULATING FACTOR 303 1.2. MOLECULAR AND BIOLOGICAL
CHARACTERIZATION 304 1.3. CHEMICAL-PHYSICAL CHARACTERIZATION 306 1.4.
GLYCOSYLATED VERSUS NONGLYCOSYLATED G-CSF 310 2. STRUCTURAL ANALYSIS 311
2.1. SEQUENCE ANALYSIS AND PEPTIDE MAPPING 311 2.2. BIOPHYSICAL ANALYSIS
315 2.3. BIOCHEMICAL ANALYSIS 316 2.4. ANALYSIS OF THE FREE CYSTEINE
RESIDUE 321 3. FORMULATION 322 3.1. REQUIREMENTS FOR NONGLYCOSYLATED
G-CSF 322 3.2. SENSITIVITY TO FREEZING*PACKAGING SOLUTION 322 XXV J
CONTENTS 3.3. SENSITIVITY TO FREEZING*REFORMULATION SOLUTION 323 4.
STABILITY AND STABILITY-INDICATING ASSAYS 323 4.1. AGGREGATION ANALYSIS
323 4.2. OXIDATION AND DETERGENT EFFECTS 324 4.3. GLUTAMINE DEAMIDATION
325 4.4. OTHER STABILITY ISSUES 325 5. CONCLUSIONS 325 REFERENCES 326
CHAPTER 8 DEVELOPMENT AND SHELF-LIFE DETERMINATION OF RECOMBINANT HUMAN
GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (LEUKINE, GM-CSF) JOHN
GEIGERT AND BARBARA F. D. GHRIST 1. THE HUMAN GM-CSF MOLECULE 329 2. THE
LEUKINE MANUFACTURING PROCESS 331 2.1. FERMENTATION AND PURIFICATION
331 2.2. FORMULATION, FILL, AND FINISH 331 3. STRUCTURAL STUDIES OF
GM-CSF 331 4. LEUKINE STABILITY 332 4.1. LEUKINE STABILITY PROGRAM 332
4.2. POTENCY BY TF-1 CELL PROLIFERATION BIOASSAY 333 4.3. PROTEIN
INTEGRITY BY SDS-PAGE SILVER STAIN 334 4.4. PROTEIN INTEGRITY BY RP-HPLC
334 4.5. PROTEIN AGGREGATION BY SE-HPLC 335 4.6. GENERAL PRODUCT QUALITY
PARAMETERS 340 5. CONCLUSION 341 REFERENCES 341 CHAPTER 9 FORMULATION
DEVELOPMENT OF AN ANTIFIBRIN MONOCLONAL ANTIBODY RADIOPHARMACEUTICAL
MADHAV S. KAMAT, GLEN L. TOLMAN, AND JOHN M. BROWN 1. INTRODUCTION 343
2. BACKGROUND ON MURINE TC-99M-ANTIFIBRIN FAB FRAGMENT 344 2.1. THE
ANTIFIBRIN MURINE MAB FAB FRAGMENT 344 2.2. TECHNETIUM-99M LABELING
CHEMISTRY 345 3. ANTIFIBRIN FAB PRODUCTION, PURIFICATION, AND
ANALYTICAL CHARACTERIZATION 347 CONTENTS XXVII 3.1. PRODUCTION AND
PURIFICATION OF ANTIFIBRIN FAB (T2GLS) 347 3.2. PREPARATION OF
ANTIFIBRIN FAB FORMULATIONS 347 3.3. ANALYTICAL CHARACTERIZATION 348 4.
PREFORMULATION STUDIES: DETERMINATION OF CRITICAL FACTORS 350 4.1.
ANTIFIBRIN T2GLS FAB 350 4.2. STANNOUS ION [SN(II)] 353 4.3. EFFECT OF
MOISTURE 354 5. FORMULATION STUDIES 355 5.1. EXCIPIENT SCREENING 356
5.2. STABILITY STUDIES AND SHELF-LIFE DETERMINATION 361 6. SUMMARY 362
REFERENCES 363 CHAPTER 10 BIOPHYSICAL CHARACTERIZATION AND FORMULATION
OF TP40: A CHIMERIC PROTEIN THAT REQUIRES A PH-DEPENDENT CONFORMATIONAL
CHANGE FOR ITS BIOLOGICAL ACTIVITY GAUTAM SANYAL, DOROTHY MARQUIS-OMER,
AND C. RUSSELL MIDDAUGH 1. INTRODUCTION 365 1.1. RATIONALE BEHIND
DESIGNING A RECOMBINANT CHIMERIC PROTEIN CONTAINING TRANSFORMING GROWTH
FACTOR-A AND A FRAGMENT OF PSEUDOMONAS EXOTOXIN (PE) 365 1.2. IN VITRO
CYTOTOXIC ACTIVITY OF TGF-A-PE40 AGAINST CARCINOMA CELL LINES RICH IN
EPIDERMAL GROWTH FACTOR RECEPTORS (EGFR) .. 366 1.3. DEVELOPMENT OF
TP40, A MUTANT FORM OF TGF-A-PE40, AS A POTENTIAL CHEMOTHERAPEUTIC AGENT
367 1.4. EXPRESSION AND PURIFICATION OF TP40 367 2. STRUCTURE-FUNCTION
CORRELATION 368 2.1. STRUCTURAL CHARACTERIZATION OF TP40 EMPLOYING
BIOPHYSICAL TECHNIQUES 368 2.2. PH-DEPENDENT STRUCTURAL CHANGES OF TP40
371 2.3. SPECULATIONS ON THE TP40 TRANSLOCATION MECHANISM 378 2.4.
EQUILIBRIUM UNFOLDING INDUCED BY GUANIDINE HYDROCHLORIDE: EVIDENCE FOR
THE PRESENCE OF A MOLTEN GLOBULE INTERMEDIATE 379 2.5. KINETICS OF
REFOLDING 385 2.6. THERMAL UNFOLDING 385 3. FORMULATION OF TP40 FOR
CLINICAL ADMINISTRATION INTO THE HUMAN URINARY BLADDER 387 3.1.
CONSIDERATIONS IN DESIGNING A STABLE AND BIOLOGICALLY ACTIVE FORMULATION
387 XXVIII CONTENTS 3.2. SELECTION OF A FORMULATION FOR INTRAVESICAL
DOSING IN THE CLINIC . . 388 3.3. FORMULATION SUMMARY 389 4. CONCLUSION
390 REFERENCES 390 CHAPTER 11 STABILITY CHARACTERIZATION AND FORMULATION
DEVELOPMENT OF RECOMBINANT HUMAN DEOXYRIBONUCLEASE I [PULMOZYME
(DORNASE ALPHA)] STEVEN J. SHIRE 1. BACKGROUND 393 1.1. CYSTIC FIBROSIS
394 1.2. BOVINE DNASE I AS TREATMENT FOR CYSTIC FIBROSIS 394 1.3. HUMAN
DNASE I AS TREATMENT FOR CYSTIC FIBROSIS 395 2. STRUCTURE AND PROPERTIES
OF DNASE I 397 2.1. PRIMARY STRUCTURE OF RHDNASE AND HOMOLOGY WITH
BDNASE 397 2.2. SECONDARY AND TERTIARY STRUCTURE 400 2.3. PHYSICAL AND
CHEMICAL PROPERTIES 401 3. ANALYTICAL CHARACTERIZATION 403 3.1. ANALYSIS
OF MOLECULAR SIZE 403 3.2. ANALYSIS OF CHARGE HETEROGENEITY 403 3.3.
ANALYSIS OF NUCLEASE ACTIVITY 405 4. FORMULATION DEVELOPMENT 406 4.1.
AEROSOL DELIVERY OF RHDNASE: CHARACTERIZATION OF DNASE AEROSOLS 406 4.2.
CHOICE OF FORMULATION COMPONENTS 408 4.3. SOLUTION STABILITY 410 4.4.
CHOICE OF CONTAINER CLOSURE 416 5. SUMMARY AND CONCLUSIONS 420
REFERENCES 422 INDEX 427
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| id | DE-604.BV011309925 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:07:34Z |
| institution | BVB |
| isbn | 0306453320 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-007597265 |
| oclc_num | 35651090 |
| open_access_boolean | |
| owner | DE-355 DE-BY-UBR DE-19 DE-BY-UBM DE-526 |
| owner_facet | DE-355 DE-BY-UBR DE-19 DE-BY-UBM DE-526 |
| physical | XXVIII, 432 S. Ill., graph. Darst. |
| publishDate | 1996 |
| publishDateSearch | 1996 |
| publishDateSort | 1996 |
| publisher | Plenum Press |
| record_format | marc |
| series | Pharmaceutical biotechnology |
| series2 | Pharmaceutical biotechnology |
| spelling | Formulation, characterization, and stability of protein drugs case histories ed. by Rodney Pearlman ... New York [u.a.] Plenum Press 1996 XXVIII, 432 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Pharmaceutical biotechnology 9 Drug Design Drug Stability Peptide drugs Protein Engineering Protein drugs Proteins analysis Proteins pharmacology Proteine (DE-588)4076388-2 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Arzneimittelstabilität (DE-588)4122835-2 gnd rswk-swf Proteine (DE-588)4076388-2 s Arzneimittel (DE-588)4003115-9 s Arzneimittelstabilität (DE-588)4122835-2 s DE-604 Pearlman, Rodney Sonstige oth Pharmaceutical biotechnology 9 (DE-604)BV007730074 9 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007597265&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Formulation, characterization, and stability of protein drugs case histories Pharmaceutical biotechnology Drug Design Drug Stability Peptide drugs Protein Engineering Protein drugs Proteins analysis Proteins pharmacology Proteine (DE-588)4076388-2 gnd Arzneimittel (DE-588)4003115-9 gnd Arzneimittelstabilität (DE-588)4122835-2 gnd |
| subject_GND | (DE-588)4076388-2 (DE-588)4003115-9 (DE-588)4122835-2 |
| title | Formulation, characterization, and stability of protein drugs case histories |
| title_auth | Formulation, characterization, and stability of protein drugs case histories |
| title_exact_search | Formulation, characterization, and stability of protein drugs case histories |
| title_full | Formulation, characterization, and stability of protein drugs case histories ed. by Rodney Pearlman ... |
| title_fullStr | Formulation, characterization, and stability of protein drugs case histories ed. by Rodney Pearlman ... |
| title_full_unstemmed | Formulation, characterization, and stability of protein drugs case histories ed. by Rodney Pearlman ... |
| title_short | Formulation, characterization, and stability of protein drugs |
| title_sort | formulation characterization and stability of protein drugs case histories |
| title_sub | case histories |
| topic | Drug Design Drug Stability Peptide drugs Protein Engineering Protein drugs Proteins analysis Proteins pharmacology Proteine (DE-588)4076388-2 gnd Arzneimittel (DE-588)4003115-9 gnd Arzneimittelstabilität (DE-588)4122835-2 gnd |
| topic_facet | Drug Design Drug Stability Peptide drugs Protein Engineering Protein drugs Proteins analysis Proteins pharmacology Proteine Arzneimittel Arzneimittelstabilität |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007597265&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV007730074 |
| work_keys_str_mv | AT pearlmanrodney formulationcharacterizationandstabilityofproteindrugscasehistories |