An Automated Sample Extraction and Processing Method Combining Immuno-Affinity and Mass Spectrometry Analysis for Biotherapeutics Quantitation

摘要

A generic method for the quantitation of humanized monoclonal antibodies (mAb) was developed using the SCIEX BioBA solution. The method, which combines immunocapture using high capacity magnetic beads followed by protein digestion and signature peptide LC-MS/MS analysis was then automated by transferring to a Beckman Coulter Biomek FXP automated liquid handling station. Testing and characterization of the performance of the automated method was conducted using a generic humanized monoclonal antibody in rat plasma. Finally, a rat dosing study was performed to generate real samples for comparative analysis of the automated method and an ELISA method. Samples from the study were split and analyzed by the two different techniques in two different labs and the results were compared.