Senior Scientist Regeneron Pharmaceuticals Elmsford, New York
This talk reveals how surfactant levels that appear sufficient in simple monoclonal antibody formulations can fail in multi-excipient systems. Using design of experiments and orthogonal analytics, we identify an excipient-dependent surfactant threshold that governs aggregation and highlight its implications for risk-informed formulation design.
Learning Objectives:
Recognize the limitations of extrapolating surfactant requirements from simplified screening systems
Differentiate the impact of common stabilizing excipients on aggregation behavior
