Measuring Sub-Visible Particulates in Biotherapeutics

Specialists at Malvern Instruments have demonstrated the application of dynamic particle image analysis to the measurement of sub-visible particulates in biological therapeutics, using the Sysmex FPIA-3000 particle characterisation system. This is an important advance since protein suspensions tend to contain sub-visible particulates that may pose health risks or affect the performance of biological therapeutics. At sizes below 10 microns, these particulates have proved difficult to characterise fully using traditional analytical techniques. This has prompted investigations into new ways of detecting the presence, measuring the size and also characterising the shape and intensity (transparency) of these particulates to ensure product safety and performance.

The Sysmex FPIA-3000 from Malvern Instruments is a dynamic particle image analysis system that incorporates optical imaging of a sample once it has been aligned by a unique sheath-flow cell. Sample alignment ensures that every single particle, from 0.8 μm to 300 μm, has its largest surface area imaged. Obtaining the maximum dimension is critical to investigations focused on safety. However, for development studies requiring further information, the system also delivers high quality, high resolution images enhanced by contrast control that enables the distinction of primary particles, foreign matter and agglomerates. This type of additional detail can provide beneficial control over the final product.