SIMI: A Different Approach to Revealing Dangerous Subvisible Impurities

Aura Systems High-throughput, fluidics-free aggregate and particle characterizatiom and identification Choose the right Aura™ Particle Analyzer for your lab’s needs + Aura+ System AuraGT System Everything in the box Gene therapy AuraBMI System AuraPTx System Biologics subvisible/ visible particle analysis…

Application Note Rapidly Distinguish Protein from Non-Protein Particles in Biologic Formulations Waters Corporation, United States Published on November 06, 2025 Abstract Subvisible particles (1 µm–100 µm) are a critical quality attribute for biologics and an indicator of stability. The presence…

Application Note Identify and Characterize Particles in the Visible Size Range with Aura Waters Corporation, United States Published on November 06, 2025 Introduction Characterizing large visible contaminants is essential for patient safety and mandated by both USP 788, 790, and…

Application Note Detect, Identify, and Characterize Cellular versus Non-cellular Aggregates with the Aura CL System Published on June 02, 2021 Introduction Cell, protein, and viral aggregates are critical quality attributes (CQAs) for all biological products.1 Subvisible biotherapeutic product aggregates indicate…