In this three-and-a-half-day course, you will learn the principles of lyophilization (freeze drying) and spray drying. Specific concepts like heat and mass transfer, critical process parameters for cycle optimization, and the advantages/limitations of each technique will be presented. Lab activities — including hands-on material characterization, freeze and spray drying runs, as well as final product testing — will be used to demonstrate the concepts presented.
Lyophilization (freeze drying) and spray drying are used in biomanufacturing as methods to improve drug product stability and increase product shelf-life. For successful implementation of these techniques, it is critical to understand the process parameters that drive each step of the drying process. These parameters include the physical properties of materials as measured by differential scanning calorimetry (DSC) and freeze-drying microscopy, the fundamental theories of heat and mass transfer, and the operational limits of the equipment in terms of geometry and flow. In this course, participants will also be introduced to a range of product-specific topics including formulation considerations, target product profiles, and critical quality attributes. Finally, this course will cover product characterization by visual inspection, scanning electron microscopy (SEM), moisture content by headspace analysis and Karl Fisher (KF) titration, reconstitution time, particulate matter, and pH.