A NEW application note from Fluid Imaging Technologies, Detection of protein aggregates in parenteral drug formulations, reveals the main challenges facing drug manufacturers in accurately detecting, counting and identifying protein aggregates.
Among the concerns discussed, it mentions the time and manpower needed for manual microscopy and the problems transparent particles present for light obscuration detection methods. Significantly, techniques including electrozone sensing, laser diffraction, and light obscuration base their measurements on the flawed assumption that particles are spherical – which the application note says compromises their accuracy and reliability.
The application note describes how the FlowCam particle imaging and analysis system automatically detects particles in a sample, taking a high-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, it claims. FlowCam was developed for pharmaceutical chemists, lab technicians, quality assurance managers, and others concerned with in the formulation, production, and testing of biologics and biopharmaceuticals.