Get USP Equivalent Data with Maurice CE-SDS

Analyzing protein size and purity has become faster and easier with automated CE-SDS platforms. However, the suitability of such methods must be measured against compendial requirements. For IgG monoclonal antibodies, the U.S Pharmacopeia (USP) General Chapter describes analytical procedures, namely size-exclusion chromatography (SEC) and capillary electrophoresis sodium dodecyl sulfate (CE-SDS), to assess therapeutic purity1. In this application note we demonstrate the comparability of the Maurice CE-SDS PLUS method with the USP protocol for analysis of monoclonal antibodies. Using USP’s IgG System Suitability Reference Standard, the USP method was first run on Maurice to determine ease of method transfer, followed by optimization of the Maurice protocol for comparison with USP.