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Bioanalysis. 2014;6(13):1747-58. doi: 10.4155/bio.14.64. Epub 2014 Mar 24.

An exploratory universal LC-MS/MS assay for bioanalysis of hinge region-stabilized human IgG4 mAbs in clinical studies.

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  • 1Bristol-Myers Squibb, R&D, Route 206 & Province Line Road, Princeton, NJ 08543, USA.



Due to the increasing number of monoclonal antibody (mAb) drug candidates entering clinical development, bioanalytical laboratories can benefit from generic liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays capable of quantifying a variety of human mAb-based therapeutic drug candidates in plasma/serum samples from clinical studies.


We have developed and evaluated an exploratory LC-MS/MS assay capable of quantifying hinge region-stabilized IgG4 therapeutic mAb drugs and drug candidates in clinical samples. The exploratory assay is based upon a single 'universal IgG4' surrogate peptide.


The novel exploratory LC-MS/MS assay reported herein, upon further refinement and full validation, is predicted to enable bioanalytical scientists to quantify all hinge region-stabilized human IgG4 therapeutic mAbs in human studies without having to develop a new assay for every new stabilized IgG4 mAb entering clinical development.

[PubMed - indexed for MEDLINE]
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