Characterization of subvisible particles in protein therapeutics has become an increasingly important means to ensure the development of safe, stable, and effective medicines. Many analytical techniques are available to identify and prevent not only protein aggregation, but to fulfill regulatory requirements. The purpose of this study by Danny Chou, President and Founder of Compassion BioSolution, LLC is to compare different techniques and their ability to identify subvisible particles and what relationship exists between the number of particles and different stress conditions imposed upon the protein drug products.
Flow Imaging Microscopy has been widely implemented for the analysis of particles ranging in size from 1-10µm. Yet, in recent years the FDA has highlighted the need for better analytical tools to fully understand how different stress conditions can impact the stability of the formulation. While light obscuration and membrane microscopy have been the primary methods to conduct USP testing for particles between 10µm - 25µm, regulators are now moving towards expecting orthogonal analytical methods to characterize and provide quantitative data on particles in the 2µm - 10µm range as well.
FlowCam Nano offers the ability to image and analyze particles ranging from 30µm down to as small as 300 nm.