Liquid Chromatography-Multiple Reaction Monitoring-Mass Spectrometry Assay for Quantitative Measurement of Therapeutic Antibody Cocktail REGEN-COV Concentrations in COVID-19 Patient Serum | Zendy

Xuefei Zhong | Zendy; Shruti Nayak | Zendy; Lili Guo | Zendy; Shivkumar Raidas | Zendy; Yunlong Zhao | Zendy; Rachel Weiss | Zendy; Matthew Andisik | Zendy; Chinnasamy Elango | Zendy; Giane Sumner | Zendy; Susan C. Irvin | Zendy; Michael A. Partridge | Zendy; Hong Yan | Zendy; Sook Yen E | Zendy; Haibo Qiu | Zendy; Yuan Mao | Zendy; Albert Torri | Zendy; Ning Li | Zendy

Open Access

Liquid Chromatography-Multiple Reaction Monitoring-Mass Spectrometry Assay for Quantitative Measurement of Therapeutic Antibody Cocktail REGEN-COV Concentrations in COVID-19 Patient Serum

Author(s) -

Xuefei Zhong,

Shruti Nayak,

Lili Guo,

Shivkumar Raidas,

Yunlong Zhao,

Rachel Weiss,

Matthew Andisik,

Chinnasamy Elango,

Giane Sumner,

Susan C. Irvin,

Michael A. Partridge,

Hong Yan,

Sook Yen E,

Haibo Qiu,

Yuan Mao,

Albert Torri,

Ning Li

Publication year - 2021

Publication title -

analytical chemistry

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.117

H-Index - 332

eISSN - 1520-6882

pISSN - 0003-2700

DOI - 10.1021/acs.analchem.1c01613

Subject(s) - chemistry , chromatography , analyte , selected reaction monitoring , immunoassay , liquid chromatography–mass spectrometry , pharmacokinetics , bioanalysis , mass spectrometry , antibody , tandem mass spectrometry , pharmacology , immunology , medicine , biology

REGEN-COV is a cocktail of two human IgG1 monoclonal antibodies (REGN10933 + REGN10987) that targets severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein and has shown great promise to reduce the SARS-CoV-2 viral load in COVID-19 patients enrolled in clinical studies. A liquid chromatography-multiple reaction monitoring-mass spectrometry (LC-MRM-MS)-based method, combined with trypsin and rAspN dual enzymatic digestion, was developed for the determination of total REGN10933 and total REGN10987 concentrations in several hundreds of pharmacokinetic (PK) serum samples from COVID-19 patients participating in phase I, II, and III clinical studies. The performance characteristics of this bioanalytical assay were evaluated with respect to linearity, accuracy, precision, selectivity, specificity, and analyte stability before and after enzymatic digestion. The developed LC-MRM-MS assay has a dynamic range from 10 to 2000 μg/mL antibody drug in the human serum matrix, which was able to cover the serum drug concentration from day 0 to day 28 after drug administration in two-dose groups for the clinical PK study of REGEN-COV. The concentrations of REGEN-COV in the two-dose groups measured by the LC-MRM-MS assay were comparable to the concentrations measured by a fully validated electrochemiluminescence (ECL) immunoassay.

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