Talks in this session will discuss approaches for accelerating clinical and commercial development by quickly developing phase appropriate formulations. Tools and approaches for rapid formulation development capable of predicting long-term stability should be emphasized. Other example topics include: the relationship of formulation to molecule selection/optimization, approaches for achieving high concentration formulations, and strategies to gain acceptable expiry by filing.
John Carpenter, University of Colorado
Ping Yeh, Amgen
Vladimir Razinkov, Amgen: High Throughput Formulation Development of Therapeutic Proteins
David Volkin, University of Kansas: Utility of High-Throughput Biophysical Analysis of Protein Stability during Formulation Development and Comparability Assessments
Robert Mueller, Roche: Phase appropriate approach for formulation development