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Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

Summary

  • Crystalline vs. amorphous vs. mixed systems
  • Eutectic melting, glass transition, and collapse temperatures
  • Partial collapse vs. meltback
  • Examples of failed products
  • Principals of thermal analysis
  • Thermal analysis equipment and techniques: DSC, DTA, TEA
  • Freeze-dry microscopy equipment and techniques
  • Applications of thermal analysis and freeze-dry microscopy techniques for solutions and solids

Overview

This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity).  Understanding if a crystalline, amorphous, mixed, and or metastable system is present in our products, is critical in developing a sound, stable formulation that can easily be freeze-dried.   Choosing excipients based solely on their stability imparting characteristics, without taking into account their thermal properties, can result in disastrous results both in the physical structure of the solids and on the long term stability.

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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