Freeze drying/lyophilization of pharmaceutical and biological products
Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This volume addresses these changes with revised chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this
1 online resource (564 pages) : illustrations.
9781439825761, 1439825769
664125915
Glimpses into the realm of freeze-drying : classical issues and new ventures / Louis Rey
Structural and dynamic properties of bulk and confined water / Marie-Claire Bellissent-Funeland, Jose Teixeira
Freezing and annealing phenomena in lyophilization / Jim A. Searles
Phase separation of freeze-dried amorphous solids : the occurrence and detection of multiple amorphous phases in pharmaceutical systems / Adora M. Padilla and Michael J. Pikal
The use of microscopy, thermal analysis, and impedance measurements to establish critical formulation parameters for freeze-drying cycle development / Kevin R. Ward and Paul Matejtschuk
The relevance of thermal properties for improving formulation and cycle development : application to freeze-drying of proteins / Stéphanie Passot [and others]
Freezing-and drying-induced perturbations of protein structure and mechanisms of protein protection by stabilizing additives / John F. Carpenter, Ken-ichi Izutsu, and Theodore W. Randolph
Mechanisms of protein stabilization during freeze-drying storage : the relative importance of thermodynamic stabilization and glassy state relaxation dynamics / Michael J. Pikal
Formulation characterization / D.Q. Wang
Practical aspects of freeze-drying of pharmaceutical and biological products using nonaqueous cosolvent systems / Dirk L. Teagarden, Wei Wang, and David S. Baker
Regulatory control of freeze-dried products : importance and evaluation of residual moisture / Joan C. May
Freeze-drying of biological standards / Paul Matejtschuk, Michelle Stanley, and Paul Jefferson
Molecular mobility of freeze-dried formulations as determined by NMR relaxation times, and its effecton storage stability / Sumie Yoshioka and Yukio Aso
Scanning electron microscopy : a powerful tool for imaging freeze-dried material / Tauno Jalanti
Pharmaceutical packaging for lyophilization applications / Claudia Dietrich [and others]
Closure and container considerations in lyophilization / Fran L. DeGrazio
Extractables and leachables as container closure considerations in lyophilization / Diane Paskiet and Fran L. DeGrazio
Optimizing the throughput of freeze-dryers within a constrained design space / Jim A. Searles
Monitoring and control of industrial freeze-drying operations : the challenge of implementing quality-by-design (QbD) / Miquel Galan
Process analytical technology in industrial freeze-drying / Antonello A. Barresi, Davide Fissore, and Daniele L. Marchisio
Practical considerations for freeze-drying in dual chamber package systems / Dirk L. Teagarden [and others]
Lyophilization and irradiation as an integrated process / Dalal Aoude-Werner and Florent Kuntz