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Comparison of Sample Purification Methods for Therapeutic Monoclonal Antibody Quantitation in Human Serum
Mohsin el Amrani, University Medical Center, University of Utrecht, The Netherlands
In recent years, there has been growing interest in quantifying biopharmaceuticals such as monoclonal antibodies (mAbs) with liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) in biological matrices for clinical research and drug monitoring research. LC-MS/MS possesses notable advantages over several other technologies with capabilities that ensure faster method development, wider linear dynamic range, and most importantly, higher selectivity. However, it can be challenging to select an appropriate and feasible sample purification method for absolute quantification of the target mAb with LC-MS/MS. In this study, a comparison between various sample purification methods for the quantification of total mAbs, including fast, economical and easy pre-analytical sample work-up will be shown. Furthermore, optimized workflow enabling the use of a stable isotopically labelled (SIL) peptide instead of SIL proteins which are commercially unavailable for most mAbs and a successful validation of quantitation assays of mAbs following EMA guidelines using the therapeutic mAbs infliximab and dinutuximab will be discussed.