Freeze-drying/lyophilization of pharmaceutical and biological products
著者
書誌事項
Freeze-drying/lyophilization of pharmaceutical and biological products
（Drugs and the pharmaceutical sciences, v. 137）
M. Dekker, c2004
2nd ed., rev. and expanded
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注記
Previous ed.: 1999
Includes bibliographical references and index
内容説明・目次
内容説明
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD (R) packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
目次
Glimpses into the Realm of Freeze-Drying - Fundamental Issues. Structural and Dynamic Properties of Bulk and Confined Water. Mechanisms of Protein Stabilization During Freeze-Drying and Storage: The Relative Importance of Thermodynamic Stabilizationand Glassy State Relaxation Dynamics. Freezing and Annealing Phenomenon in Lyophilization. Freezing- and Drying-Induced Perturbations of Protein Structure andMechanisms of Protein Protection by Stabilizing Additives. Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation, and its Effect on Storage Stability. Formulation Characterization. Practical Aspects of Freeze-Drying ofPharmaceutical and Biological Products Using Non-Aqueous Co-solvent Systems. Closure and Container Considerations in Lyophilization. Advanced Glass-Ware for Freeze-DryingCritical steps in the Preparation of Elastomeric Closures for BiopharmaceuticalFreeze-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. IndustrialFreeze-Drying for Pharmaceutical Applications. Development of Process Data In a Pilot Plant Transferable to Production. Technical Procedures for Operation of Cleaning-in-Place and Sterilization-in-Place Process for Production Freeze-Drying Equipment.Freeze-Drying Cycle Parameters Global Validation by Using Integral HFT Systems. Lyophilizer Qualification: Some Practical Advice. Lyophilization Process Validation. A New Development: Irradiation of Pharmaceutical and Biological Products. Some LeadingEdge Prospects in Freeze-Drying
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