Quantitative analysis of antibody aggregates by combination of pinched-flow fractionation and coulter method.

For the pharmaceutical development of proteins, multiple methods of analysis are recommended for evaluating aggregation, and the development of more quantitative and simpler analytical techniques for subvisible particles is expected. This study introduces the Pinched-Flow Fractionation (PFF)-Coulter method, which combines the Pinched-flow fractionation (PFF) and Coulter methods to analyze the concentration of submicron-sized particles. The PFF method separates the particles by size.