First Paper on the FabRICATOR®-HPLC Column from Genentech

February 5, 2020 | References |

Scientist at Genentech and the University of Geneva have used FabRICATOR-HPLC to set up an automated workflow for the analysis of monoclonal antibodies by LC-MS.

 

Developing and manufacturing therapeutic antibodies requires the analysis of many product quality attributes. Robust and fast analytical methods are needed to support process development and quality control. In this new paper by Camperi et al., a novel workflow for automated subunit analysis of mAbs is described. Samples were digested on-column using FabRICATOR-HPLC and then transferred to a reverse phase HPLC column where the subunits could be separated and analyzed by mass spectrometry. This allowed for a completely hands-off analysis of critical quality attributes such as Fc glycosylation, glycation and C-terminal lysine clipping. More than 150 injections were performed on the same FabRICATOR-HPLC column with reliable results. Furthermore, analysis of a bispecific antibody revealed product related impurities due to mispairing of the chains.

 

FabRICATOR-HPLC enables on-line sample preparation for middle-level analysis and therefore reduces operator time and errors due to sample handling.

 

Camperi et al., 2020. Automated middle-up approach for the characterization of biotherapeutic products by combining on-line hinge-specific digestion with RPLC-HRMS analysis. Journal of Pharmaceutical and Biomedical analysis. doi: 10.1016/j.jpba.2020.113130

 

Link to FabRICATOR-HPLC Product page and Poster below