Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition - Market Research

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition
List Price: Eur 173
ISBN: 0824748689
Publication Date: 1/21/2004
Number of Pages: 600
Availability: In Stock
The 13 chapters new to this Second Edition provide state-of-the-art information on
" freeze-drying using nonaqueous cosolvent systems
" formulation characterization, and molecular mobility determination via NMR relaxation
" modern closure and container options for lyophilization
" selection of advanced glassware for freeze-drying
" specific considerations in the freeze-drying of biological standards
" developing process data to facilitate the move from pilot plant to production
" the use of integral HFT systems in the global validation of cycle parameters
" contemporary opinions and guidelines for lyophilizer qualification
" the technological horizon for freeze-drying
" and many more topics!
Audience:
Thoroughly acquainting the reader with freeze-drying fundamentals-including water properties critical to the process and mechanisms and means of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures-ensuring the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation.
Table of Contents
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 Stabilization and Glassy State Relaxation Dynamics. Freezing and Annealing Phenomenon 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 Effect 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 Glass-Ware 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 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 Leading Edge Prospects in Freeze-Drying