Characterization of Biotherapeutics 2011

OPENING KEYNOTE PRESENTATION:

Introductory Presentation: Overview of Current Analytical Technologies in the Biopharmaceutical Characterization Field, and Where Changes are Required to Address Unmet Needs

Jennifer Nemeth, Ph.D., Principal Research Scientist, Biologics Mass Spectrometry & Allied Technologies, Centocor R&D, Inc.

There are a wide range of analytical tools for the assessment and characterization of biopharmaceuticals. Generally, a set of tools and processes are established, and the path to making changes down the line can be difficult, even in a discovery environment. Obstacles to change are not necessarily related to SOPS and regulations, but to lack of development time and hesitancy to “do something different.” Here, an examination of advances in standard technologies, or a new look at little-used ones, will be provided, and proposals on how these technologies might enhance the biopharmaceutical discovery/development process will be presented.