Formulation and process development strategies for manufacturing biopharmaceuticals [[electronic resource] /] / edited by Feroz Jameel, Susan Hershenson
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| Titolo: |
Formulation and process development strategies for manufacturing biopharmaceuticals [[electronic resource] /] / edited by Feroz Jameel, Susan Hershenson
|
| Pubblicazione: | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica: | 1 online resource (986 p.) |
| Disciplina: | 615.19 |
| 615/.7 | |
| Soggetto topico: | Biopharmaceutics |
| Pharmaceutical technology | |
| Altri autori: |
JameelFeroz
HershensonSusan
|
| Note generali: | Description based upon print version of record. |
| Nota di bibliografia: | Includes bibliographical references and index. |
| Nota di contenuto: | FORMULATION AND PROCESS DEVELOPMENT STRATEGIES FOR MANUFACTURING BIOPHARMACEUTICALS; CONTENTS; FOREWORD; PREFACE; CONTRIBUTORS; PART I PREFORMULATION AND DEVELOPMENT OF STABILITY-INDICATING ASSAYS: BIOPHYSICAL CHARACTERIZATION TECHNIQUES; 1 THE STRUCTURE OF BIOLOGICAL THERAPEUTICS; 2 CHEMICAL INSTABILITY IN PEPTIDE AND PROTEIN PHARMACEUTICALS; 3 PHYSICAL STABILITY OF PROTEIN PHARMACEUTICALS; 4 IMMUNOGENICITY OF THERAPEUTIC PROTEINS; 5 PREFORMULATION RESEARCH: ASSESSING PROTEIN; 6 FORMULATION DEVELOPMENT OF PHASE 1-2 BIOPHARMACEUTICALS: AN EFFICIENT AND TIMELY APPROACH |
| 7 LATE-STAGE FORMULATION DEVELOPMENT AND CHARACTERIZATION OF BIOPHARMACEUTICALS8 AN EMPIRICAL PHASE DIAGRAM-HIGH-THROUGHPUT SCREENING APPROACH TO THE CHARACTERIZATION AND FORMULATION OF BIOPHARMACEUTICALS; 9 FLUORESCENCE AND PHOSPHORESCENCE METHODS TO PROBE PROTEIN STRUCTURE AND STABILITY IN ICE: THE CASE OF AZURIN; 10 APPLICATIONS OF SEDIMENTATION VELOCITY ANALYTICAL ULTRACENTRIFUGATION; 11 FIELD FLOW FRACTIONATION WITH MULTIANGLE LIGHT SCATTERING FOR MEASURING PARTICLE SIZE DISTRIBUTIONS OF VIRUS-LIKE PARTICLES | |
| 12 LIGHT-SCATTERING TECHNIQUES AND THEIR APPLICATION TO FORMULATION AND AGGREGATION CONCERNSPART II DEVELOPMENT OF A FORMULATION FOR LIQUID DOSAGE FORM; 13 EFFECTIVE APPROACHES TO FORMULATION DEVELOPMENT OF BIOPHARMACEUTICALS; 14 PREDICTION OF AGGREGATION PROPENSITY FROM PRIMARY SEQUENCE INFORMATION; 15 HIGH-CONCENTRATION ANTIBODY FORMULATIONS; 16 DEVELOPMENT OF FORMULATIONS FOR THERAPEUTIC MONOCLONAL ANTIBODIES AND Fc FUSION PROTEINS; 17 REVERSIBLE SELF-ASSOCIATION OF PHARMACEUTICAL PROTEINS: CHARACTERIZATION AND CASE STUDIES; PART III DEVELOPMENT OF A FORMULATION FOR LYOPHILIZED DOSAGE FORM | |
| 18 DESIGN OF A FORMULATION FOR FREEZE DRYING19 PROTEIN CONFORMATION AND REACTIVITY IN AMORPHOUS SOLIDS; 20 THE IMPACT OF BUFFER ON SOLID-STATE PROPERTIES AND STABILITY OF FREEZE-DRIED DOSAGE FORMS; 21 STABILIZATION OF LYOPHILIZED PHARMACEUTICALS BY CONTROL OF MOLECULAR MOBILITY: IMPACT OF THERMAL HISTORY; 22 STRUCTURAL ANALYSIS OF PROTEINS IN DRIED MATRICES; 23 THE IMPACT OF FORMULATION AND DRYING PROCESSES ON THE CHARACTERISTICS AND PERFORMANCE OF BIOPHARMACEUTICAL POWDERS; PART IV MANUFACTURING SCIENCES; 24 MANUFACTURING FUNDAMENTALS FOR BIOPHARMACEUTICALS | |
| 25 PROTEIN STABILITY DURING BIOPROCESSING26 FREEZING AND THAWING OF PROTEIN SOLUTIONS; 27 STRATEGIES FOR BULK STORAGE AND SHIPMENT OF PROTEINS; 28 DRYING PROCESS METHODS FOR BIOPHARMACEUTICAL PRODUCTS: AN OVERVIEW; 29 SPRAY DRYING OF BIOPHARMACEUTICALS AND VACCINES; 30 DEVELOPMENT AND OPTIMIZATION OF THE FREEZE-DRYING PROCESSES; 31 CONSIDERATIONS FOR SUCCESSFUL LYOPHILIZATION PROCESS SCALE-UP, TECHNOLOGY TRANSFER, AND ROUTINE PRODUCTION; 32 PROCESS ROBUSTNESS IN FREEZE DRYING OF BIOPHARMACEUTICALS; 33 FILLING PROCESSES AND TECHNOLOGIES FOR LIQUID BIOPHARMACEUTICALS | |
| 34 LEACHABLES AND EXTRACTABLES | |
| Sommario/riassunto: | A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining p |
| Titolo autorizzato: | Formulation and process development strategies for manufacturing biopharmaceuticals |
| ISBN: | 1-282-70758-2 |
| 9786612707582 | |
| 0-470-59588-4 | |
| 0-470-59587-6 | |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910140773403321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |