The effect of protein concentration on the viscosity of a recombinant albumin solution formulation

Abstract

The effect of protein concentration on solution viscosity in a commercially available biopharmaceutical formulation of recombinant albumin (rAlbumin) was studied. The level of protein aggregation with concentration and its impact on solution viscosity was investigated. Theoretical models predicting viscosity with concentration were applied to these data, and a model that accounts for multiple protein species in solution provided the best fit. The results highlight the need to account for heterogeneity in the level of aggregation when addressing the increase of viscosity observed at high concentrations of protein solutions, a significant issue for the manufacture and use of protein-based therapeutics.