Evaluation of the potential use of hybrid LC-MS/MS for active drug quantification applying the 'free analyte QC concept'

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Abstract

Aim: Assessment of active drug exposure of biologics may be crucial for drug development. Typically, ligand-binding assay methods are used to provide free/active drug concentrations. To what extent hybrid LC-MS/MS procedures enable correct 'active' drug quantification is currently under consideration. Experimental & results: The relevance of appropriate extraction condition was evaluated by a hybrid target capture immuno-affinity LC-MS/MS method using total and free/active quality controls (QCs). The rapid extraction (10 min) provided correct results, whereas overnight incubation resulted in significant overestimation of the free/active drug (monclonal antibody) concentration. Conventional total QCs were inappropriate to determine optimal method conditions in contrast to free/active QCs. Conclusion: The 'free/active analyte QC concept' enables development of appropriate extraction conditions for correct active drug quantification by hybrid LC-MS/MS.

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Jordan, G., Onami, I., Heinrich, J., & Staack, R. F. (2017). Evaluation of the potential use of hybrid LC-MS/MS for active drug quantification applying the “free analyte QC concept.” Bioanalysis, 9(21), 1705–1717. https://doi.org/10.4155/bio-2017-0158

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