title: Flow imaging: moving toward best practices for subvisible particle quantitation in protein products.
abstract: 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® 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.
authors.affiliation: West Coast BioDesign, Santa Barbara, California, USA.
authors.forename: Glenn A
authors.initials: GA
authors.lastname: Wilson
authors.forename: Mark Cornell
authors.initials: MC
authors.lastname: Manning
mesh_terms: D007091:Image Processing, Computer-Assisted / Q000379:methods; D008853:Microscopy / Q000379:methods*; D010316:Particle Size; D011506:Proteins / Q000737:chemistry*
chemical_list: D011506:Proteins