The characterization of subvisible particles is highly relevant for the development of biopharmaceuticals to ensure quality and safety of a therapy. The expectations by the authorities are increasing, which makes it necessary to include analytical methods for subvisible particles in the nanometer and micrometer size range. The classification of particles is particularly crucial for products in prefilled syringes, where silicone oil droplets and protein aggregates can co-exist. In the upper nanometer and lower micrometer size range, resonant mass measurement (Archimedes) allows for the quantitative differentiation of these two particle types by a physical parameter; the buoyancy. It further delivers particle concentrations and size distributions with little to no sample preparation, all in a size range where few other techniques fulfill this task.
In this webinar, Daniel Weinbuch, an independent scientist from Coriolis Pharma, introduces you to the field of subvisible particle analysis and give an overview on existing methods. He explains the principle of resonant mass measurement (Archimedes) as emerging technique for quantification and classification of particles in the upper nanometer to lower micrometer size range and present a case study, where the capabilities of resonant mass measurement are evaluated.