The positive impacts of therapeutic proteins on the lives of people suffering from cancer, diabetes, multiple sclerosis, Crohn’s disease, ALS, lupus, arthritis and other diseases and conditions have attracted significant investment in drug research and development.
As a result, hundreds of therapeutic protein-based drugs have earned FDA approval, with enormous benefits to human health. With the rapid growth and acceptance of these biologics, more and more information about impacts of product quality on patient outcomes has become available. Based on this growing body of evidence, one of the most important product quality attributes is the concentration and sizes of subvisible particles.
"Lives are on the line when it comes to correct understanding of how therapeutic proteins can form particulate" says Professor John Carpenter, PhD, Professor of Pharmaceutical Sciences and Co-Director of the Center for Pharmaceutical Biotechnology at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences.
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The FlowCam continues to be an important instrument in biopharmaceutical research. The ability to image and characterize morphological features of particulate in parenteral formulations is an important aspect of ensuring quality and safety in injectable drug products.
Biopharmaceutical manufacturers strive to ensure patient safety, avoid recalls and protect company reputations. Identifying subvisible particles is an important step in preventing recalls of parenterals. One aspect of product safety is defined in the United States Pharmacopeia (USP) 788 guidelines for particle sizing. This was designed to control for particles capable of causing capillary occlusion, and therefore focuses on particles larger than 10 µm and 25 µm. As such, no characterization is required for particles below 10 µm. 
