Antibody self-association, non-specific binding & phase separation

Nikolai Lorenzen, Scientific Director, Biophysics & Injectable Formulation 1, Novo Nordisk

Marketed biologics are often formulated at high protein concentrations, such at 50-150 mg/ml. Pronounced reversible self-association is often occurring, and can lead to macroscopic issues such as viscosity, opalescence and phase separation. I will provide few examples, to display common issues we are facing during formulation development.