Article: Advancing Subvisible Particle Characterization with AI

This new article from Coriolis Pharma presents AI-powered flow imaging microscopy as a breakthrough in particle analysis. Through its partnership with ParticleSentryAI, Coriolis enables deeper particle insights, supporting better formulation decisions, improved product quality, and faster development of safe biopharmaceuticals.

Traditional particle analysis methods often provide only limited insights beyond pure particle size and counts. AI-powered flow imaging microscopy enables a deeper, more concrete understanding of particles. By leveraging machine learning, Coriolis Pharma’s exclusive partnership with the developers of ParticleSentryAI enhances drug formulation, ensures product quality, and accelerates decision-making — leading to safer, high-quality biopharmaceutical products.

Moving Beyond Traditional Particle Analysis with Flow Imaging Microscopy

The presence of subvisible particles in drug products can significantly impact their safety and efficacy. While it is crucial to reduce the number of particles, it is — especially during drug development — an equally important task to further characterize the particles to understand their influence on product stability and performance.

Historically, light obscuration has been the standard technique for analyzing subvisible particles, but it provides only limited data, primarily measuring particle count and particle size without offering insights into their composition or structure. This limitation makes it impossible to differentiate between particle types and assess their impact on a drug product or withdraw information to guide process development.

Coriolis Pharma has been at the forefront of advancing flow imaging microscopy as a more powerful and sample-efficient solution for comprehensive particle characterization. By capturing images of particles, this method enables a deeper understanding of their size and morphology, including aspect ratio and intensity distribution. This capability not only allows researchers to distinguish between different types of particles — such as protein particles and silicone oil droplets — but also helps to track how formulation and process changes influence particle formation. The ability to analyze particles in greater detail empowers biopharmaceutical developers to refine formulations early in development, ensuring product quality and safety from the outset.