Highly concentrated proteins
Nanolytics has been routinely using the Aida ultracentrifuge for several years to analyze therapeutic proteins at concentrations above 50 g/L. The maximum amenable protein concentration is about 150 g/L, enabling the AUC user to monitor therapeutic proteins formulated at such extremely high concentrations under the original conditions without dilution or buffer change. By developing a consistent experimental design and data fit approach, we are able to provide a reliable estimation of the minimum content of soluble aggregates of highly concentrated proteins up to 150 g/L. The subsequent diagram shows the raw data as well as sedimentation coefficient distributions of an antibody at 147 g/L formulated in citrate buffer containing sugar osmolytes as recently published.