INFLUENCE OF DIGESTION CONDITIONS ON POST-TRANSLATIONAL MODIFICATIONS IN MONOCLONAL ANTIBODIES

摘要

Post-translational modifications (PTMs) on monoclonal antibodies (mAbs) are potential critical quality attributes that define therapeutic efficacy and safety[1]. Mass spectrometry based peptide mapping (PM) is the gold standard methodology for the in-depth study of PTMs on mAbs. Artificial PTMs, however, may be induced during sample preparation for PM, e.g. asparagine deamidation [2]. The current work describes the effect of digestion pH and incubation time on Trastuzumab PTMs. Trastuzumab, marketed as Herceptin, is a humanized IgG1 mAb used in the treatment of HER2 positive breast cancer.