Imaging Particle Analysis Overcomes Shortcomings Of Light Obscuration, Laser Diffraction

Yarmouth, ME: A new application note from laboratory instrumentation manufacturer Fluid Imaging Technologies, Yarmouth, Maine (www.fluidimaging.com) reveals the top challenges facing parenteral drug manufacturers concerned with accurately detecting, counting and identifying protein aggregates in their biological drug formulations. The new application note, entitled “Detection of Protein Aggregates in Parenteral Drug Formulations,” cites the time and labor required of manual microscopy and the inability of light obscuration to properly detect and measure transparent particles among the chief concerns. In addition, light obscuration, electrozone sensing and laser diffraction instruments base their measurements on the inherently flawed assumption that all particles must be spherical rather than using the true particle size and shape, which compromises the accuracy and reliability of their data, according to the application note.

Developed for pharmaceutical chemists, laboratory technicians, quality assurance managers and others involved in the formulation, production and testing of biologics and other biopharmaceuticals, the illustrated application note describes how the FlowCAM® particle imaging and analysis system overcomes these shortcomings by automatically detecting particles in a sample, taking a hi-resolution, digital image of each one and saving the images for analysis with the count, size, shape and nearly 30 other corresponding measurements, all in real time. Protein aggregates, silicone oil droplets, air bubbles and foreign particulates – even sub-visible, transparent and translucent particles - may be automatically differentiated, characterized and identified.

For more information, contact Lew Brown, Fluid Imaging Technologies, Inc.; 65 Forest Falls Drive, Yarmouth, ME 04096; 207.846.6100.; Fax 207.846.6110; www.fluidimaging.com; lew@fluidimaging.com.