This hands-on freeze drying workshop provides a unique approach to learning formulation development and lyophilization. Students are presented with model molecules and are responsible for all aspects of formulation and process development including excipient choices, thermal analyses and optimizing the freeze drying cycle. Course instructors for the lyophilization training provide guidance throughout the process but allow students to work through challenges just as they would in their own laboratories. Students work in small collaborative groups on an assigned formulation. The lectures and instructors provide information for each stage of the development process with the goal of identifying an optimum freeze drying cycle at the end of the workshop.
See below for course outline and additional information.
The first day of the workshop focuses on formulation development with the goal of freeze drying samples by the end of the day. Model molecules are provided to the working groups and each group determines the data needed to support formulation and process development. Their direction is aided by lectures on the selection of possible excipients and thermal analysis. The formulation is needed by the end of the day to provide samples for an initial test cycle.
The focus of the second day is gathering data to support optimization of the lyophilization cycle. The groups will examine their formulations using differential scanning calorimetry and freeze-dry microscopy. Lectures on the lyophilization process, lyophilizer design, and process monitoring will aid the groups in analysis of in-process data and understanding the effect of thermal behavior of the formulation on design of the lyophilization cycle. A second lyophilization cycle will be started by the end of the day and using parameters that support an optimized cycle.
Day 3 will conclude with evaluation of the samples and in-process data from both cycles. Lectures on product testing and advances in lyophilization will provide the groups with ideas for future experiments, testing, and factors affecting the quality of the product.
Instrumentation used during class is based on availability. Materials, and supplies necessary for successful completion of this course will be provided onsite by the Hooke College of Applied Sciences.
Students are expected to successfully complete a variety of tasks in the form of hands-on exercises, laboratory exercises, identifications of unknowns, and quizzes. Students are notified at the end of the course whether or not they have successfully completed the requirements of the course based on:
Upon successfully meeting these requirements, a student is awarded a certificate of completion and CEU credits, if available. Those who have not successfully passed the course requirements do not receive a certificate or CEU credits.
Scientists in the pharmaceutical, biological, tissue and food industries using lyophilization as an analytical method.