Characterization of protein aggregates and extrinsic particles from cell line development through release

Aura PTx is a complete protein therapeutic stability solution that enables characterization of subvisible particle aggregates from developability assessment through product release. Aura PTx is a high throughput analytical instrument that images, counts, sizes, and identifies subvisible particle aggregates, a critical quality attribute and the most important biologic stability parameter. Using volumes as low as 10 µL and with measurements of one minute per sample, Aura PTx enables rapid, highly contrast and thorough subvisible particle screening and absolute particle quantification.

In addition, it is powered by fluorescence membrane microscopy, a proprietary technique than enables individual particle identification analysis, which is helpful to identify and segment particles as protein aggregates, degraded polysorbate particles, and other particulate impurities relevant to protein therapeutic development.

In this talk, we overview the ability to perform subvisible particle analysis from cell line development through developability assessment, into product development and release as it is USP 1788 Method 2 compliant.