UNIT PROCESSES IN PHARMACY
CONTENTS GLIMPSES INTO THE REALM OF FREEZE-DRYING: FUNDAMENTAL ISSUES STRUCTURAL AND DYNAMIC PROPERTIES OF BULK AND CON?NED WATER MECHANISMS OF PROTEIN STABILIZATION DURING FREEZE-DRYING AND STORAGE: THE RELATIVE IMPORTANCE OF THERMODYNAMIC STABILIZATION AND GLASSY STATE RELAXATION DYNAMICS FREEZING AND ANNEALING PHENOMENA IN LYOPHILIZATION FREEZING- AND DRYING-INDUCED PERTURBATIONS OF PROTEIN STRUCTURE AND MECHANISMS OF PROTEIN PROTECTION BY STABILIZING ADDITIVES MOLECULAR MOBILITY OF FREEZE-DRIED FORMULATIONS AS DETERMINED BY NMR RELAXATION, AND ITS E?ECT ON STORAGE STABILITY FORMULATION CHARACTERIZATION PRACTICAL ASPECTS OF FREEZE-DRYING OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS USING NON-AQUEOUS CO-SOLVENT SYSTEMS CLOSURE AND CONTAINER CONSIDERATIONS IN LYOPHILIZATION ADVANCED GLASSWARE FOR FREEZE-DRYING CRITICAL STEPS IN THE PREPARATION OF ELASTOMERIC CLOSURES FOR BIOPHARMACEUTICAL FREEZE-DRIED PRODUCTS DEVELOPMENT OF A NEW CONCEPT FOR BULK FREEZE-DRYING: LYOGUARD FREEZE-DRY PACKAGING REGULATORY CONTROL OF FREEZE-DRIED PRODUCTS: IMPORTANCE AND EVALUATION OF RESIDUAL MOISTURE FREEZE-DRYING OF BIOLOGICAL STANDARDS INDUSTRIAL FREEZE-DRYING FOR PHARMACEUTICAL APPLICATIONS DEVELOPMENT OF PROCESS DATA IN A PILOT PLANT TRANSFERABLE TO PRODUCTION TECHNICAL PROCEDURES FOR OPERATION OF CLEANING-IN-PLACE/STERILIZATION-IN-PLACE PROCESS FOR PRODUCTION FREEZE-DRYING EQUIPMENT GLOBAL VALIDATION OF FREEZE-DRYING CYCLE PARAMETERS BY USING INTEGRAL HFT SYSTEMS LYOPHILIZER QUALI?CATION: SOME PRACTICAL ADVICE LYOPHILIZATION PROCESS VALIDATION A NEW DEVELOPMENT: IRRADIATION OF FREEZE-DRIED VACCINE AND OTHER SELECT BIOLOGICAL PRODUCTS SOME LEADING EDGE PROSPECTS IN LYOPHILIZATION