A central challenge with particle analysis in biotherapeutics is the wide size range of particles that may be present, including particles from the active pharmaceutical ingredient (API), as well as excipients and contaminants. These particles can be as small as a few nanometers (e.g., oligomer-sized protein aggregates, individual viruses) or large enough to be seen by the unaided eye (e.g., visible API aggregates). While several analytical techniques exist for particle monitoring, each can only analyze particles within a finite size range.
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In this white paper, we demonstrate how using a combination of orthogonal and complementary particle analysis techniques can give you a complete picture of the particles in your sample. We analyzed a simple protein formulation that was exposed to accelerated shaking and heat stress using four analytical techniques: subvisible flow imaging microscopy (FlowCam LO), light obscuration (FlowCam LO), submicron flow imaging microscopy (FlowCam Nano), and dynamic light scattering (DynaPro NanoStar). Additionally, this study used these particle measurement techniques to investigate the impact of surfactants on protein aggregation by performing the shaking and heat stress both with and without the presence of polysorbate 80. |
