The use of flow cytometry for the detection of subvisible particles in therapeutic protein formulations

✍ Scribed by Henryk Mach; Akhilesh Bhambhani; Brian K. Meyer; Steven Burek; Harrison Davis; Jeffrey T. Blue; Robert K. Evans

• Publisher: John Wiley and Sons
• Year: 2011
• Tongue: English
• Weight: 261 KB
• Volume: 100
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.22414

✦ Synopsis

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 μ 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.