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 or large enough to be visible. While several analytical techniques exist for particle monitoring, each can only analyze particles within a finite size range.
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 protein formulation that was exposed to accelerated shaking and heat stress using four analytical techniques: subvisible flow imaging microscopy, light obscuration, submicron flow imaging microscopy, and dynamic light scattering.
