Imaging Particle Analysis - Characterization of Protein Aggregates in Parenterals
 The FlowCAM® is being used by several leading pharmaceutical companies to characterize particles - such as protein aggregates (image on right), air bubbles and silicone (Si) oil droplets - in therapeutic protein formulations and vaccines. Imaging particle analysis provides a much more detailed look at the particulates than does classical light obscuration technologies used to comply with USP method <788>. Not only does FlowCAM provide information on particle size, concentration and appearance, but it also requires much less sample than light obscuration techniques (typically less than 1ml). Further, FlowCAM can characterize agglomerates which are transparent and therefore not detected by light obscuration devices.
The advantages of using FlowCAM over traditional techniques (such as light obscuration) and other imaging methods for this application are:
- Greater sensitivity to transparent particles
- Over 30 different measurements/particle, as opposed to just ESD (Equivalent Spherical Diameter)
- Industry-leading image quality for better measurements and characterization
- High-precision syringe pump for sample sizes as small as 35µm
- Automated filtering/characterization during the run using VisualSpreadsheet® Software
- Automated separation of silicone droplets and air bubbles
Plenty of information on this application is available for download via the links on the right side of the page. In addition, for some detailed background information presented by 3 industry experts on this subject, please view the on-demand webcast sponsored by Drug Discovery & Development:
Submit this form to request more detailed information, request a quote, or request a free sample analysis! Send us your fluid sample and we will provide for free:
- A Web-based interactive presentation of the results
- A scattergram showing the size and distribution of particles
- An Excel spreadsheet with all the measurement data, including count, length, width, and ESD.
- Digital images of the cells and particles in your sample
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