Analyzing for Small Molecules in Large-Molecule Pharmaceuticals The potential of capillary electrophoresis Aldo Hörmann, Maria Schwarz, Fabian Stapf Solvias AG, Kaiseraugst, Switzerland Corresponding author: Dr. Aldo Hörmann, Solvias AG, Römerpark 2, 4303 Kaiseraugst, Switzerland, e-mail: aldo.hoermann@solvias.com All biopharmaceuticals contain small molecules. Some are introduced during upstream manufacture of the biopharmaceutical and must be removed later during downstream processing. Still others are added in the formulation to get a stable drug product. Analysis of biopharmaceuticals for small molecules is thus critical to ensure safety and efficacy and for process development. Capillary electrophoresis (CE) is a very powerful method to assess small molecules. In this article we review the technology and illustrate the versatility and potential of the method to a number of analytes in samples typically obtained in the production and final release of biopharmaceuticals. Recently, we worked successfully on quantitation of cyclodextrin in a formulation by CE. We will present the results of this exploratory study on cyclodextrins which are becoming an ever more important additive in protein formulations. Key words Biopharmaceuticals • Capillary electrophoresis • Small molecules |
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pharmind 2011, Nr. 12, Seite 2222
