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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 micro-droplets and other particles.
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.