Halo Labs
Abstract:
Subvisible particles (1 μm – 100 μm) are a critical quality attribute for biologics and an indicator of stability. The presence of protein aggregates can limit a product’s shelf life and are a key indicator of the potential immunogenicity of a drug. In this application note we introduce Fluorescence Membrane Microscopy (FMM). FMM, exclusively available in the Aura® system, is a high throughput, low volume, subvisible particle identification technology. FMM enables ultra-fast, 100% sampling efficiency, characterizing all particles from a single protein aggregate to tens of millions of particles in an entire multi-sample formulation, in under two hours.
