Follow-on Biologics Workshop
Monday, December 12, 2005 - Wednesday, December 14, 2005
Presented By
The goal of this meeting is to address the scientific issues associated with the characterization and demonstration of similarity of protein pharmaceutical products. This event will provide an overview of currently available analytical methodologies and technologies as well as perspectives on future technology. The focus will be on the use of analytical techniques to characterize follow-on biologics and on the role of the fermentation and purification processes in determining product quality attributes. Also addressed will be challenges to characterizing and comparing proteins in the absence of reference standards for the active pharmaceutical ingredient.
Organizing committee:
- Kurt Brorson, CDER, FDA
- David Bunk, NIST
- Andrew Chang, CBER, FDA
- Barry Cherney, CDER, FDA
- Kathleen A. Clouse, CDER, FDA
- Blair Fraser, CDER, FDA
- Travis Gallagher, NIST
- Marcia Holden, NIST
- Christopher Joneckis, CBER, FDA
- Curtis Meuse, NIST
- Stephen Moore, CDER, FDA
- Amy Rosenberg, CDER, FDA
- Emily Shacter, CDER, FDA
- Marjorie Shapiro, CDER, FDA
- Victoria R. Sutton, CDER, FDA