Lyophilization of Pharmaceuticals and Biologicals

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(TM)).- 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.