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  • Title: Use of generic LC-MS/MS assays to characterize atypical PK profile of a biotherapeutic monoclonal antibody.
    Author: Law WS, Genin JC, Miess C, Treton G, Warren AP, Lloyd P, Dudal S, Krantz C.
    Journal: Bioanalysis; 2014; 6(23):3225-35. PubMed ID: 25529889.
    Abstract:
    BACKGROUND: The fully human monoclonal antibody mAb123, which binds to and neutralizes chemokine motif ligand-21 (CCL21) displays a faster clearance in cynomolgus monkey compared with typical IgG kinetics. A direct and an immunoaffinity LC-MS/MS assays were developed to compare with the previously established ligand-binding assays (LBAs). RESULTS: A strong correlation of LC-MS/MS pharmacokinetic data with LBA data confirmed the rapid drug disposition of mAb123 is an intrinsic property of the molecule, rather than interference of anti-mAb123 antibodies in the LBA. CONCLUSION: The data illustrate that in cases of unexpected results from LBA, application of orthogonal bioanalytical techniques such as LC-MS/MS can help in in interpretation of pharmacokinetic as determined by LBAs.
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