Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 100, Issue 5, Pages 1671-1678Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.22414
Keywords
analytical biochemistry; high-throughput technologies; imaging methods; light scattering; particle size; protein aggregation; protein formulation; stability
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The amount, identity, and size distribution of particles in parenteral therapeutic protein formulations are of immense interest due to potential safety and efficacy-related implications. In this communication, we describe the use of a flow cytometer equipped with forward-and side-scattering as well as fluorescence detectors, to determine the number of subvisible particles in monoclonal antibody formulations. The method appears to detect particles of size 1 : and larger, requiring relatively small sample volumes to estimate subvisible particle counts. Additionally, it facilitates differentiation of proteinaceous particles after staining with a fluorescent hydrophobic dye. The method is expected to be particularly well suited for pharmaceutical development, because it provides increased throughput due to the use of a 96-well autosampler. (C) 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:1671-1678, 2011
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