Application Note: Enhanced Detection of Host-Cell Proteins in Biotherapeutic Preparations using Preparative Electrophoresis Followed by LC–Ion Mobility–MS
23 February 2016
This application note investigates the use of an off-line preparative electrophoresis device to fractionate Host-cell proteins (HCPs) away from the biotherapeutic protein prior to LC-MS analysis. Host-cell proteins (HCPs) are proteins produced by the host cells during recombinant protein drug production. These HCPs contaminate the biotherapeutic drug protein at low levels (1-100 ppm) even after several steps of extensive purification. Since even low level HCPs can stimulate an immunogenic response, regulatory guidelines mandate that these HCPs must be identified and quantified to protect patient safety. Current HCP mass spectrometry (MS) characterization involves some level of pre-fractionation (i.e., electrophoresis, reversed-phase (RP) separation, 2D RP/RP LC, etc.) prior to analysis.
