Chemistry Seminar - Dr. Mary Krause

High Concentration Formulation Development of Biologic Drug Products

Dr. Mary Krause, an alumna of MSU, is an associate scientific director in the drug product development department of Bristol Myers Squibb, a global biopharmaceutical company. Her current research focuses on physical and chemical degradation of proteins that can occur during development and manufacturing; in particular, she is a subject matter expert on metal catalyzed oxidation of proteins.

In this presentation, we will explore a case study where a formulation screening DoE approach was applied to an Fc fusion protein to optimize the formulation for a high concentration drug product presentation for subcutaneous administration. The formulations that provided the most optimal stability profiles were then screened using small-scale tools to assess the impact of interfacial and shear stresses present during drug product development. Combining formulation screening with formulation performance informed not only the storage stability but also the processing operational space needed to maintain integrity of this unique protein drug product in different formulations.

Free