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Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products
Abstract
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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Cited by
Freeze-drying of nanoparticles: Formulation, process and storage considerations
ABDELWAHED, W., DEGOBERT, G., STAINMESSE, S., & FESSI, H. (2006) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2006.09.017 · Cited by 1,611
Interactions of formulation excipients with proteins in solution and in the dried state
Ohtake, S., Kita, Y., & Arakawa, T. (2011) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2011.06.011 · Cited by 398
García-González, C. A., Camino-Rey, M. C., Alnaief, M., Zetzl, C., & Smirnova, I. (2012) · The Journal of Supercritical Fluids · doi:10.1016/j.supflu.2012.02.026 · Cited by 349
Metadata
- Venue
- CRC Press eBooks
- Publisher
- CRC Press
- Published
- 2016-04-19
- OpenAlex
- W2155429140
- Cited by
- 245
- References
- 0
- FWCI
- 13.03
- Type
- book
- Language
- en
- Open access
- closed
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