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
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.
Robert Mueller
Since 2010, Dr. Müller leads a technical development group in the Late-Stage Pharmaceutical and Processing Development at F. Hoffmann-La Roche Ltd (Basel, Switzerland) with the main focus based on commercial protein formulation and process development.
2008, Dr. Müller took over a formulation research lab in the group of Formulation R&D Biologics at F. Hoffmann-La Roche Ltd (Basel, Switzerland) working on early-stage biotech R&D projects.
Vladimir Razinkov
Amgen Inc., Seattle, WA. Principal Scientist, Department of Drug Product Development working in formulation and pre-formulation development. High throughput screening, candidate selection and characterization of biopharmaceuticals.