Poster MFI 2014 Sensitive Discrimination of Protein Aggregates and Sub-Visible Particle Types

Concentration and morphologic distributions of particle sub-populations is required to ensure product quality of biopharmaceuticals. However, current pharmacopeial methods are not optimized for transparent protein aggregates which can lead to undercounting. MFI addresses this technology gap, combining sensitive image capture and morphologic analysis that can discriminate translucent protein particles from silicone µ-droplets and other particles.