Stability studies are essential for assessing a biotherapeutic’s sensitivity to factors that cause aggregation and ultimately degradation of the biologic. This can impact the biologic’s activity, efficacy, safety, and quality. Separating active pharmaceutical ingredients from other particle types in biotherapeutic formulations helps scientists understand the root causes of drug instability. But existing methods of characterizing particles are unreliable, slow, require significant sample volume, or are difficult to use across different therapeutics.
The Aura® platform from Halo Labs is a USP 788 and 1788 compatible, low-volume, high throughput particle imaging system that addresses these problems. It rapidly sizes, counts, and characterizes non-proteins, polysorbate degradants, cellular and protein aggregates, or other types of molecules in heterogenous samples.
In this webinar, you’ll learn how Aura+ leverages innovative modern imaging and fluorescence microscopy techniques developed specifically for the life sciences to characterize protein, gene, and cell therapy products in stability studies. The presentation will also highlight key applications of the platform such as performing developability assessments for potential biologics.