Measuring Subvisible Particles and Aggregates Using FlowCam LO

Simultaneously collect flow imaging microscopy and light obscuration data from a single aliquot of sample

While measuring subvisible particles in pharmaceutical products with light obscuration (LO) is standard, the FDA has long made clear that size data collected with LO alone is insufficient to ensure safe and effective drugs. Orthogonal methods such as flow imaging microscopy (FIM) are necessary to provide validation.

With the FlowCam LO, the first and only light obscuration (LO) instrument with flow imaging capabilities is now available. In this white paper, you will learn how the FlowCam LO is used to directly compare the particle size distributions of aqueous samples such as ETFE particles and IgG aggregates obtained by both techniques in the same instrument. The results highlight how a combined LO-FIM approach using the FlowCam LO can help researchers accurately detect, count, and characterize particles in biotherapeutic samples while still meeting pharmacopeial requirements for particle monitoring.

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compliments of Yokogawa Fluid Imaging Technologies.