Formulation and process development strategies for manufacturing of a biopharmaceuticals / edited by Feroz Jameel, Susan Hershenson. — Oxford : Wiley, 2010. – (82.915/F726)

Contents

    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 SOLUTION BEHAVIOR DURING EARLY DEVELOPMENT 119
    6 FORMULATION DEVELOPMENT OF PHASE 1-2 BIOPHARMACEUTICALS: AN EFFICIENT AND TIMELY APPROACH 147
    7 LATE-STAGE FORMULATION DEVELOPMENT AND CHARACTERIZATION OF BIOPHARMACEUTICALS
    8 AN EMPIRICAL PHASE DIAGRAM-HIGH-THROUGHPUT SCREENING APPROACH TO THE CHARACTERIZATION AND FORMULATION OF BIOPHARMACEUTICALS 173
    9 FLUORESCENCE AND PHOSPHORESCENCE METHODS TO PROBE PROTEIN STRUCTURE AND STABILITY IN ICE: THE CASE OF AZURIN 207
    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 CONCERNS 269
    PART II DEVELOPMENT OF A FORMULATION FOR LIQUID DOSAGE FORM 307
    13 EFFECTIVE APPROACHES TO FORMULATION DEVELOPMENT OF BIOPHARMACEUTICALS
    14 PREDICTION OF AGGREGATION PROPENSITY FROM PRIMARY SEQUENCE INFORMATION
    15 HIGH-CONCENTRATION ANTIBODY FORMULATIONS 349
    16 DEVELOPMENT OF FORMULATIONS FOR THERAPEUTIC MONOCLONAL ANTIBODIES AND Fc FUSION PROTEINS 383
    17 REVERSIBLE SELF-ASSOCIATION OF PHARMACEUTICAL PROTEINS: CHARACTERIZATION AND CASE STUDIES 429
    PART III DEVELOPMENT OF A FORMULATION FOR LYOPHILIZED DOSAGE FORM
    18 DESIGN OF A FORMULATION FOR FREEZE DRYING
    19 PROTEIN CONFORMATION AND REACTIVITY IN AMORPHOUS SOLIDS
    20 THE IMPACT OF BUFFER ON SOLID-STATE PROPERTIES AND STABILITY OF FREEZE-DRIED DOSAGE FORMS 507
    21 STABILIZATION OF LYOPHILIZED PHARMACEUTICALS BY CONTROL OF MOLECULAR MOBILITY: IMPACT OF THERMAL HISTORY
    22 STRUCTURAL ANALYSIS OF PROTEINS IN DRIED MATRICES 549
    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 BIOPROCESSING 605
    26 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 739
    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
    35 PRIMARY CONTAINER AND CLOSURE SELECTION FOR BIOPHARMACEUTICALS
    36 PREFILLED SYRINGES FOR BIOPHARMACEUTICALS
    37 IMPACT OF MANUFACTURING PROCESSES ON DRUG PRODUCT STABILITY AND QUALITY
    INDEX