Michaël Biacchi | Authors


Comprehensive Multilevel Characterization of Biologics Using Sheathless Capillary Electrophoresis Hyphenated to Tandem Mass Spectrometry

An analytical methodology for the characterization of the primary structure of biotherapeutic proteins using sheathless CE–ESI-MS-MS instrumentation is presented. For the first time, complete sequence coverage can be achieved using a bottom-up proteomic approach from a single analysis of a tryptic digest. In a biosimilarity assessment, a single amino acid substitution was detected.