Differentiation and Characterization of Subvisible Particulates in Therapeutic Protein Products

Guidance from the FDA for the biopharmaceutical industry states “Naturally sourced products should be evaluated for other components, protein and non-protein”. This application note provides an example of how the Malvern Instruments’ Archimedes system can be used to detect and quantify the formation of protein sub-visible particles and the introduction of silicone oil droplets, in response to shear stress.