Particle Analyzers
Particles are common in drug products and are a leading cause of injectable drug product recalls. They can be extrinsic (foreign contaminants), intrinsic (rubber, plastic, or glass from consumables or process impurities), or inherent (protein, capsid, or cell aggregates). These particles threaten patient safety, impact product quality and efficacy, and are monitored closely by the FDA.
Aura is the only system designed to bridge the gap from early-stage development through QC with low volume requirements (as little as 5 µL), high-throughput (1 minute per sample), particle ID capabilities using side illumination membrane imaging (SIMI) and fluorescence membrane microscopy (FMM), and compatibility with regulatory requirements <787>, <788>, and <789>.
