ArticleThe AAPS journal2026
Simultaneous LC-MS/MS Quantification Method for Cassette-Dosing Pharmacokinetics Study of Monoclonal Antibodies Using Alanine Modifications in Constant Region.
Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
We developed a novel cassette-dosing pharmacokinetic (PK) evaluation method that combines antibody engineering with multiplex liquid chromatography-tandem mass spectrometry (LC-MS/MS). The antibody was engineered by introducing alanine mutations or insertions into the GPSVFPLAPSSK sequence on the CH1 domain of IgG1, thereby enabling clear differentiation and simultaneous measurement of multiple antibodies recognizing the same antigen. Twelve antibodies, one unmodified and eleven modified, were selected for this study and evaluated for assay performance and PK. The method was validated with intra-day and inter-day assay data, which demonstrated accuracy ranging from 70.3% to 128.4% and precision (%CV) less than or equal to 28.7% for all antibodies. The mouse PK profiles of modified antibodies after intravenous administration were comparable to that of the unmodified antibody, with no statistical differences in key PK parameters (t
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