This 2 ½ day workshop combines lectures with work in the laboratory to demonstrate design of lyophilization cycles and the dependence of the process on the thermal behavior of the formulation. Efficient lyophilization cycles are desired to reduce the cost of manufacturing and to aid in production planning. The challenge is that much of time used in new product development is spent on drug design, analytical method development, and stability studies. This leaves little time for the development of an efficient lyophilization cycle and can lead to freeze drying methods that vary widely between companies. Attendees work in groups to examine formulations containing pharmaceutical excipients. Each group builds data sets for their formulation using differential scanning calorimetry (DSC), freeze-dry microscopy, and Micro Freeze Dryers. Thermal analysis equipment is used to identify the critical product temperature for the formulation, such as the eutectic temperature or a collapse temperature. The Micro Freeze Dryers are equipped with freeze drying technology developed by Millrock Technology. The equipment includes heat flow sensors and controlled nucleation for use during the workshop. There is ample opportunity to discuss, analyze, and share the data between the groups and opportunity to discuss challenges with experts in lyophilization research and development.
Previous participants hailed from the pharmaceutical, food sciences, diagnostics, and tissue preservation industries. The case studies and lectures are based on freeze drying of pharmaceuticals, but the material, equipment, and interactive discussions apply to all industries.
Scroll to the Course Details below for the course outline and additional information.
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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 three 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.
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.