Contract Lyophilization and Lyophilization Cycle Development
Available from University of Iowa Pharmaceuticals
The University of Iowa Pharmaceuticals (UIP) has a Lyotherm 2 and Lyostat 2 which greatly aid lyophilization cycle development. The Lyotherm 2 has integrated Differential Thermal Analysis (DTA) and electrical impedance (Zsinφ) capability in a single instrument. This allows measurement of glass transition (Tg'), eutectic (Teu) and melting (Tm) temperatures relevant to freeze-drying formulations. The Lyostat 2 is a fully integrated freeze-drying microscope that enables critical events, such as collapse and melting, to be observed in situ, as well as characteristics such as skin or crust formation to be observed and identified. The coupled Lyostat 2 and Lyotherm 2 units provide valuable information for both formulation and cycle development processes. Once cycle parameters have been identified UIP has a Lyostar development lyophilizer that can be used to further refine the lyophilization cycle parameters. After the cycle is fully characterized GMP clinical supplies can be produced in our 48 square foot Hull lyophilizer.