Novel In Vitro Serum Stability Assay for Antibody Therapeutics

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In vitro stability assessment plays a pivotal role in proactively identifying potential liabilities of antibody therapeutics prior to animal studies. The liquid chromatography-mass spectrometry (LC-MS)-based assays typically involve 3 steps: incubation of antibodies in biological matrices, affinity purification, and LC-MS analysis. To our best knowledge, there are no reported instances of routine in vitro stability screening methods involving internal standards which could be applied to antibody therapeutics across different biological modalities. Operational errors and uncompensated variations in sample evaporation, protein precipitation, sample recovery after affinity purification, and matrix effect during LC-MS analysis could lead to inaccurate stability estimation. By incorporating internal standards, a more accurate stability assessment could be implemented for routine screening.