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Lyophilization Process Development and Cycle Design with a Case Study

Summary

  • 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

Overview

This seminar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.  In the past, a “trial and error” approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive.  By taking the time to characterize the thermal properties of each formulation and understanding how to use this information correctly during each phase of cycle development, the process 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.

Who should attend?

  • Quality Control Scientists

  • Development Scientists

  • Production Management

  • Quality Assurance

J. Jeff Schwegman

Expert

J. Jeff Schwegman, Ph.D. iscurrently the founder and chief executive officer of AB BioTechnologies(www.ab-biotech.com) where he develops formulations, lyophilization cycles,determines residual moisture by Karl Fischer, and provides thermalcharacterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes inspeaking and consulting in parenteral pre-formulation, formulation, analytical,and lyophilization of both small molecules and large biomolecules. He also holds patents and develops newtechnologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in1992 and began working at Cook Imaging in Bloomington Indiana, where he gainedexperience in analytical, formulation and process development.

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