This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab.
Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

Includes cutting-edge techniques Provides step-by-step detail essential for reproducible results Contains key implementation advice from the experts

Inhalt

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.