Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2485600 | Journal of Pharmaceutical Sciences | 2011 | 8 Pages |
Abstract
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.
Keywords
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
Henryk Mach, Akhilesh Bhambhani, Brian K. Meyer, Steven Burek, Harrison Davis, Jeffrey T. Blue, Robert K. Evans,