Lyophilization Cycle Design – A Practical Guide to Process Optimization
Lyophilization is a difficult and expensive process. However, simple steps can be taken to minimize risks and costs. This course will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle, which will improve the quality and consistency of the product while also reducing the cycle time and associated costs.
Topics of discussion will include:
- Thermal characterization including DSC and FDM
- Understanding the effects of working with crystalline vs. amorphous components
- The problem with working with a metastable glassy system and the use of annealing to correct this problem
- Determining optimal shelf temperatures for the freezing step
- Determining optimal shelf temperatures and chamber pressures for the primary drying step
- Determining optimal shelf temperatures and chamber pressures for the secondary drying step
- Characterization of the finished lyophilized product
This course will provide valuable assistance to those companies involved in the handling of lyophilized pharmaceutical products, diagnostics, tissues, and freeze-dried foods. Specifically, those in following positions will benefit from this course:
- Quality Control Scientists
- Development Scientists
- Production Management
- Quality Assurance
J. Jeff Schwegman, Ph.D. is the founder and chief executive officer of AB BioTechnologies where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field.
Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization. Dr. Schwegman received his PhD from Purdue University in 2003, and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group.
In November 2005, he left Baxter and formed BioConvergence LLC with 3 other founders which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he left BioConvergence, which has become a successful company, to form AB BioTechnologies. He is currently the course Director for a 4-day course called “Lyophilization Technology, a Hands-On Approach”, which he teaches through SP Scientific. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.