Lyophilization of Pharmaceuticals and Biologicals : New Technologies and Approaches - Ward, Kevin R.; Matejtschuk, Paul.; SpringerLink (Online service) (New York, NY : Springer New York : Imprint: Humana, 2019)
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.
Keywords: Pharmacology; Pharmacology/Toxicology.