Enhanced Detection of Host-Cell Proteins in Biotherapeutic Preparations using Preparative Electrophoresis Followed by LC -Ion Mobility - MS

摘要

The SageELF separation device results in reproducible protein level fractionation across duplicate experiments for the intact and reduced mAb protin separations. Based on our results, the SageELF pre-fractionation of intact non-reduced protein samples has shown to identify/quantify more sub-ppm level HCPs than the reduced antibody separation method. The spiked control proteins PYGM_RABIT and ADH1_YEAST in the intact mAb experiment are successfully identified in ± 1 predicted SageELF fraction at 100 and 10 ppm levels, respectively. Sub-ppm level HCP detection was achieved - 58 HCP proteins detected ≤ 1 ppm with 3 unique peptides/protein.