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2014 Archived Content

SHORT COURSE 10: PROTEIN AGGREGATION: MECHANISM AND CHARACTERIZATION

 

Tuesday, January 14 | 5:00-8:00 pm



This short course will aim to outline the considerations and direction taken when evaluating and understanding Extractables and Leachables present in either Single-Use Systems or Final Packaging. The course will be begin with outlining key fundamentals of material chemistry and typical leachable sources, while also highlighting properties that govern migration of these compounds. Further incorporation of industry-recognized "best practices" with these concepts will introduce evaluation strategies and explain the thought process in designing appropriate analytical studies to assess these systems. Throughout the course, strategies to overcome typical obstacles encountered in such E&L programs will be illustrated. Finally, resources associated with establishing suitable testing criteria and safety assessments will be presented.

The topics to be covered:

  • Which phenomena are described by the term “protein aggregation”?
  • How do protein aggregates form, and what factors influence their formation?
  • What are the consequences of aggregate formation?
  • Can aggregation be predicted?
  • What are the key analytical challenges and tools for characterization of protein aggregates?

 

Instructor:

Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Industrial and Physical Pharmacy, Purdue University

Daniel Some, Ph.D., Principal Scientist, Wyatt Technology


Speaker Biographies

 

Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Industrial and Physical Pharmacy, Purdue University

Elizabeth M. Topp is Dane O. Kildsig Chair and Head of the Department of Industrial and Physical Pharmacy at Purdue University in West Lafayette, Indiana.  She received a bachelor’s degree in chemical engineering from the University of Delaware in 1979 (B.Ch.E.), a master’s in chemical and biochemical engineering from the University of Pennsylvania in1984 (M.E.) and a Ph.D. in pharmaceutics from the University of Michigan in 1986. Dr. Topp’s research addresses the chemical and physical stability of protein drugs, with particular emphasis on the solid state. She currently serves as acting chair of the Advisory Committee on the Pharmaceutical Sciences and Clinical Pharmacology for the U.S. Food and Drug Administration and is a Fellow of the American Association of Pharmaceutical Scientists.

Daniel Some, Ph.D., Principal Scientist, Wyatt Technology

Daniel Some is Principal Scientist and Director of Marketing at Wyatt Technology Corp. Previously he was product manager for the Calypso system, responsible for developing the hardware and software of CG-MALS. He has authored a review article, a book chapter and multiple application notes on CG-MALS as well as several patent applications. Prior to joining Wyatt Technology, Dr. Some spent over a decade in the semiconductor and defense industries.


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