Novel Software Analysis of Protein Aggregation and Particle Analysis using Micro-Flow Imaging (MFI) (WCBP 2013)

Many features of protein-based pharmaceuticals limit the ability of standard particle analysis methods to characterize them. For example, high particle concentrations, heterogeneous particle types, viscosity, and a low refractive index are known to reduce the detection and sizing accuracy of light obscuration and membrane microscopy. As reviewed in this poster, micro-Flow Imaging (MFI) technology can analyze many types of challenging protein samples using direct, imaging-based particle measurement. Particle types detected include semi-transparent protein fragments, air bubbles, and contaminants such as silicone oil micro-droplets. Moreover, MFI detection is largely independent of a particle's optical properties; thus it can handle concentrated antibody solutions, as well as viscous samples.