Advanced Subvisible Particle Analysis for Biotherapeutics Development

Light obscuration and counting methods work well for opaque particles but struggle with translucent particles such as protein aggregates, which pose the greatest immunogenic risk to patients. These semi-transparent aggregates have refractive indices similar to aqueous formulations, making them nearly invisible to traditional detection methods. Particles not measured in solution but on a membrane substrate resolve these issues; however, they can induce changes in the number and types of particles detected.

FlowCam offers a solution-based imaging approach to measure translucent particles in their native buffer environment. These measurements reveal critical particles that counting methods miss entirely, giving you complete visibility into your particle profile.

FlowCam LO combines USP <788> compendial light obscuration data with imaging analysis in one efficient run. This satisfies regulatory requirements and accelerates investigations, enabling faster decisions, whether issues stem from API degradation, process contamination, or container problems, to keep manufacturing timelines on track.

Stability testing requires an understanding of particle behavior over time. FlowCam tracks morphological changes that indicate specific degradation pathways, providing the visual evidence that explains particle behavior in regulatory stability submissions. This data supports formulation modifications and enables accurate prediction of long-term product performance under different stress conditions.

The greatest impact occurs in the drug development phases, when particle specifications are most critical for regulatory viability. Early adoption also streamlines process development, stability profiling, and scale-up, ensuring fewer surprises during commercialization.

FlowCam distinguishes between protein aggregates, silicone oil droplets, glass particles, metallic fragments, rubber stopper material, and other process contaminants.

Each particle type carries unique morphological signatures that enable precise identification and corrective action, giving teams the complete particle profile they need to make informed formulation and quality decisions.