Critical Evaluation and Guidance for Using the Coulter Method for Counting Subvisible Particles in Protein Solutions

In this paper, we evaluate the suitability of Coulter method for detecting and quantifying subvisible particles in protein solutions and compare results with other particle-counting technologies. The effects of key instrument and operational parameters such as aperture diameter, solution conductivity, and cleaning procedures are demonstrated. Degraded and nondegraded intravenous immunoglobulin and human serum albumin were chosen as model...