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.
Session Co-Chairs:
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John Carpenter, University of Colorado
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Ping Yeh, Amgen
Confirmed Speakers
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Vladimir Razinkov, Amgen: High Throughput Formulation Development of Therapeutic Proteins
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David Volkin, University of Kansas: Utility of High-Throughput Biophysical Analysis of Protein Stability during Formulation Development and Comparability Assessments
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Robert Mueller, Roche: Phase appropriate approach for formulation development