Flow imaging: Moving toward best practices for subvisible particle quantitation in protein products

The potential impact of subvisible particles (SVPs) in protein therapeutic products has received a great deal of attention recently. As a result, new analytical methods have emerged to characterize and quantify SVPs. Among these, flow imaging (also called flow microscopy) has been widely employed. As we have used both FlowCAM (R) and Micro-Flow Imaging in a variety of development projects, we wished to share our experiences and observations, with the intention of fostering a discussion that will lead to best practices for the use of flow imaging to quantify SVP levels in biopharmaceuticals. (c) 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:11331134, 2013