Lyophilization - An Introduction to the Scientific Principles
Course Description – Introductory Lyophilization Training:
This course serves as an introduction to the basics of freeze drying as it relates to the pharmaceutical, biological and diagnostic industries. The session will begin with a brief discussion of the scientific principles of freeze-drying and how these relate to modern equipment and component design. This will be followed by a discussion of the thermal properties of formulated products including the physical properties of the different materials routinely used for freeze-dried products (eutectic and glassy phases), and the modern methods used to characterize these different phases to determine glass transition temperatures and eutectic melting temperatures. Finally, the session will conclude with a discussion of how these thermal properties affect not only the choices made for developing a stable formulation, but also in how these properties drive cycle design and optimization.
By understanding the basics of freeze-drying and properly characterizing the thermal properties of each product, the development scientist can ensure that a quality product – meeting both chemical and physical quality specifications – can be produced in the shortest amount of time possible.
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.