3rd AccBio / QbD Proceedings

Session: Formulation Approaches

Co-Chairs

Ping Yeh , Amgen
John Carpenter, University of Colorado Health Sciences Center

Presentations

08:35 AM

High Throughput Formulation Development of Therapeutic Proteins
Vladimir Razinkov

09:05 AM

Utility of High-Throughput Biophysical Analysis of Protein Stability during Formulation Development and Comparability Assessments
David Volkin

09:35 AM

Application of QbD Principles in Demonstrating Formulation Robustness and Container Closure Compatibility of a Prefilled Syringe Drug Product
Mark Brader

10:05 AM

Phase Appropriate Approach for Formulation Development
Robert Muller