Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 102, Issue 3, Pages 1133-1134Publisher
WILEY-BLACKWELL
DOI: 10.1002/jps.23445
Keywords
flow imaging; subvisible particles; image analysis; imaging methods; protein formulation; particle size; analytical biochemistry
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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
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