Biopharmaceutical formulations contain particle impurities in the sub-micron and micron size ranges, which can be intrinsic (e.g., protein aggregates), inherent (e.g., from excipients, silicone oil droplets from primary packaging) and/or extrinsic (e.g., particles from production process). These impurities can affect the product’s stability and shelf-life as well as cause adverse effects once introduced into the human body. Therefore, well-established methods are required to quantify and characterize sub-visible particles. There are many analytical techniques available for particle characterization, however, each of them has its limitations and no technique is able to size heterogeneous particles covering the range from nanometers to visible microns.

The goal of this project is to establish comprehensive methods for analyzing particles of diverse sizes in biopharmaceutical formulations and in biologically complex media, which will be applied to better understand the pathways leading to aggregate/particulate formation of protein-based drugs in their formulation and after administration.