Case Studies on Failed Cycles and/or Formulations of Lyophilized Products
J. 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. 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.
This webinar will initially give a background on the basics of freeze-dried products and the freeze-drying process. Special attention will be given to the thermal properties of a product (glass transitions, eutectic melts, etc.), and how these properties are affected by heat, residual moisture, and different excipients. Several case studies in failed freeze-dried products due to poorly designed cycles, and or poorly designed formulations will be presented in an interactive format., in which attendees will be presented with all of the data from the failed batch and will be given time to respond as to why the batch failed, and what should be changed to prevent future failures.
- Failed Products/Cycles
- Description of failure with sample images
- Cycle parameters and printouts
- Formulation details
- Corrective actions to correct failures
Course Level - Intermediate
Who Should Attend
This webinar will provide valuable assistance to those companies involved in the development and scale-up of therapeutic and diagnostic lyophilized products.
- Quality Control Scientists
- Development Scientists
- Production Management
- Quality Assurance
Why Should You Attend
Failed batches of lyophilized products are unfortunately an all too common event on those companies producing freeze-dried products, including pharmaceuticals, diagnostics, foods, vaccines, etc. Since freeze-drying is the most expensive unit operation of a manufacturing process, it is in a company’s best interest to keep failures to a minimum, and if they do occur, being able to quickly diagnose the failure and prevent it from happening again. By having a good understanding of the factors that can result in failed batches and taking a methodical approach to determining why the failure occurred, the development scientist is in a much better position to quickly correct failures and prevent them from happening in the future, saving the company both time and money.