Antwi K, Niederkofler E, Kiernan U.
ASMS 2015 Poster
Purpose: To develop a highly sensitive and reproducible pre-clinical bioanalytical solution specific for fully human therapeutic monoclonal antibodies. Methods: A systematic study was performed to develop a universal hybrid bioanalytical workflow solution for the targeted analysis of therapeutic monoclonal antibodies (mAb). Focusing on the enablement of preclinical discovery and development research, the resultant automated and high throughput Mass Spectrometric Immunoassay (MSIA™) utilized HRAM for detection for the added benefit of intact mAb detection. Specifically enabled with MSIA D.A.R.T.’S technologies (molecular trapping mico-columns within a pipette housing), the workflow was able to selectively analyze for a fully human therapeutic mAbs within rodent model plasma samples by using biotinylated anti-human Fc region affinity ligands. This universal solution demonstrated %CV’s, analytical precision and sensitivity akin to a traditional Ligand Binding Assay, which is needed for effective therapeutic development. Results: We were able to reproducibly detect adalimumab at concentrations as low as 20 ng/mL directly from mouse plasma
Thermo Fisher Scientific