Description
Lyophilization of Pharmaceuticals and Biologicals, 1st ed. 2019
New Technologies and Approaches
Methods in Pharmacology and Toxicology Series
Coordinators: Ward Kevin R., Matejtschuk Paul
Language: EnglishSubject for Lyophilization of Pharmaceuticals and Biologicals:
382 p. · 17.8x25.4 cm · Hardback
Description
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Characterization of Formulations for Freeze Drying.- Formulation and Process Development for Lyophilized Biological Reference Materials.- Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method.- Alternative Methods of Controlling Nucleation in Freeze Drying.- Tunable Diode Laser Absorption Spectroscopy in Lyophilization.- Containment Options for the Freeze-Drying of Biological Entities and Potent Materials.- Freeze Drying Systems: Freeze Dryer Design Requirements & Automatic Loading and Unloading Systems (ALUS™).- Regulatory Aspects of Freeze Drying.- Container and Reconstitution Systems for Lyophilized Drug Products.- Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT) and Statistical Analysis.- Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development.- Lyophilization of High-Concentration Protein Formulations.- Mechanical Behavior and Structure of Freeze Dried Cakes.- High Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids.