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General LC-MS/MS Method Approach to Quantify Therapeutic Monoclonal Antibodies Using a Common Whole Antibody Internal Standard with Application to Preclinical Studies

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PKDM and Protein Sciences, Amgen Inc., Thousand Oaks, California 91320, United States
*E-mail: [email protected]. Tel.: 805/447-9463. Fax: 805/499-9072. Address: One Amgen Center Drive, MS 30E-3-B, Amgen Inc., Thousand Oaks, CA 91320.
Cite this: Anal. Chem. 2012, 84, 3, 1267–1273
Publication Date (Web):January 5, 2012
https://doi.org/10.1021/ac202792n
Copyright © 2012 American Chemical Society

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    Abstract

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    Ligand binding assays (LBAs) are widely used for therapeutic monoclonal antibody (mAb) quantification in biological samples. Major limitations are long method development times, reagent procurement, and matrix effects. LC-MS/MS methods using signature peptides are emerging as an alternative approach, which typically use a stable isotope labeled signature peptide as the internal standard (IS). However, a new IS has to be generated for every candidate, and the IS may not correct for variations at all processing steps. We have developed a general LC-MS/MS method approach employing a uniformly heavy-isotope labeled common whole mAb IS and a common immunocapture for sample processing. The method was streamlined with automation for consistency and throughput. Method qualification of four IgG2 and four IgG1 mAbs showed sensitivity of 0.1 μg/mL and linearity of 0.1–15 μg/mL. Quality control (QC) data of these eight mAbs were accurate and precise. The QC performance of the whole molecule labeled IS was better than those of synthetic labeled IS peptides tested. The pharmacokinetic results of two mAbs (an IgG2 and IgG1 candidate) dosed in rats were comparable to those of LBA. The general LC-MS/MS method approach overcomes the limitations of current methods to reduce time and resources required for preclinical studies.

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