Freeze-dry microscopy, as part of a complete thermal analysis study, is an invaluable tool in the characterization of the thermal properties of any formulation. It allows you to save a significant amount of time in money both in process development and in commercial manufacturing. Freeze-drying, as a unit operation in the production of parenteral products, is becoming more prevalent as many of the new molecular entities coming out of discovery do not have sufficient shelf life in the solution state (< 2 years). Since freeze-drying is the most expensive and time consuming step in the parenteral manufacturing process, it is in the best interest of companies developing new products to make sure that they are running an optimized lyophilization cycle.

Our course begins with presentation of some of the basic theories behind lyophilization and polarized light microscopy, followed by a “hands on” demonstration of the set up and alignment of the freeze-dry microscopy system. Each student practices using the freeze-dry microscope system by measuring the thermal properties of various crystalline and amorphous samples. The course finishes with a demonstration of how the collected data can be used for lyophilization cycle development and optimization.