Formulation Approaches

Tuesday, February 26, 2013, 8:30am-10:40am PST

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:

  • John Carpenter, University of Colorado

  • Ping Yeh, Amgen

Confirmed Speakers

  • 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

David Volkin

Dr. Volkin is Takeru and Aya Higuchi Distinguished Professor of Pharmaceutical Chemistry at the University of Kansas. He is also co-Director of KU’s Macromolecular and Vaccine Stabilization Center.  His research interests include characterization, stabilization, formulation and delivery of protein drugs and vaccines.  In 2010, Dr. Volkin joined the KU faculty after 20 years in the pharmaceutical industry, including senior director positions at Merck Research Laboratories and Centocor R&D.  He led formulation and analytical R&D groups responsible for developing dosage forms and...