Jeff Schwegman
Instructor Jeff Schwegman
Product Id 600696
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

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

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. Next, there will be a thorough discussion of the analytical techniques used to characterize the thermal properties of the formulated product. These techniques allow the development scientist to understand not only what types of materials are present, but also the critical temperatures that are associated with these materials (glass transition temperature, eutectic melting temperature, annealing temperature, etc.). Finally, the webinar will conclude with a brief discussion of some of the specialized analytical techniques that can be employed to characterize the lyophilized solids. Understanding the physical properties of the dried solids allows the development scientist to be able to troubleshoot, diagnose, and correct a problematic formulation and or lyophilization cycle.

Areas Covered in the Session:

  • 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
Learning Objectives:
  • Understanding the thermal properties of a formulation (crystalline, amorphous, mixed)
  • Understanding the critical temperatures (Tg’, Te, Tc) of a formulation
  • Understanding different excipients in formulations and how they affect the thermal properties
Who Will Benefit:
  • Quality Control Scientists
  • Development Scientists
  • Production Management
  • Quality Assurance

Speaker Profile
Jeff Schwegman, Ph.D. is currently 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 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 3-day course called Lyophilization Technology which he teaches through the Center for Professional Innovation and Education. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.

Sign Up for Our Newsletter