Therapeutic drug monitoring for monoclonal antibody：progress in the application of LC-MS/MS technique

XIA Ying; GUO Hongli; HU Yahui; CHEN Feng

doi:10.11665/j.issn.1000-5048.20210117

Journal of China Pharmaceutical University > 2021 > 52(1): 122-128. > DOI: 10.11665/j.issn.1000-5048.20210117

XIA Ying, GUO Hongli, HU Yahui, CHEN Feng. Therapeutic drug monitoring for monoclonal antibody：progress in the application of LC-MS/MS technique[J]. Journal of China Pharmaceutical University, 2021, 52(1): 122-128. DOI: 10.11665/j.issn.1000-5048.20210117

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Therapeutic drug monitoring for monoclonal antibody：progress in the application of LC-MS/MS technique

Pharmaceutical Sciences Research Center, Department of Pharmacy, Children's Hospital of Nanjing Medical University, Nanjing 210008, China

Funds: This study was supported by the Specially-Appointed Medical Expert Project of Jiangsu Commission of Health (2019) and the Hospital Pharmacy Foundation of Jiangsu Pharmaceutical Association-Aosaikang Pharmaceuticals (No.A202010)

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Received Date: July 03, 2020
Revised Date: August 13, 2020

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Abstract

Abstract

With the rapid development of biopharmaceuticals, therapeutic monoclonal antibodies (mAbs) are widely accepted due to their low side-effects and high therapeutic efficacy. Individual differences in the response to mAb drugs put forward new requirements for therapeutic drug monitoring of antibody drugs.Therefore, the need for accurate and robust bioanalytical methods is increasing.Recently, LC-MS/MS has been gaining increasing interest in the field of large molecules.In this article, the recent advances in this emerging field are reviewed, along with common issues and analytical approaches.Thus, this review article is helpful for better understanding the advance of LC-MS/MS technique in the field of therapeutic drug monitoring for mAbs.
- monoclonal antibody,
- LC-MS/MS,
- quantification analysis,
- therapeutic drug monitoring

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References (49)

References

[1]	. MAbs， 2018， 10（2）： 183-203.
[2]	Oude Munnink TH， Henstra MJ， Segerink LI， et al. Therapeutic drug monitoring of monoclonal antibodies in inflammatory and malignant disease： translating TNF-α experience to oncology［J］. Clin Pharmacol Ther， 2016， 99（4）： 419-431.
[3]	Vozy A， Zalcman G. Pembrolizumab for the treatment of non-small-cell lung cancer［J］. Oncologie， 2015， 17（9）： 407-408.
[4]	Ecker DM， Jones SD， Levine HL. The therapeutic monoclonal antibody market［J］. MAbs， 2015， 7（1）： 9-14.
[5]	Singh S， Kumar NK， Dwiwedi P， et al. Monoclonal antibodies： a review［J］. Curr Clin Pharmacol， 2018， 13（2）： 85-99.
[6]	Widmer N， Bardin C， Chatelut E， et al. Review of therapeutic drug monitoring of anticancer drugs part two： targeted therapies［J］. Eur J Cancer， 2014， 50（12）： 2020-2036.
[7]	Dreesen E， Bossuyt P， Mulleman D， et al. Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases［J］. Clin Pharmacol， 2017， 9： 101-111.
[8]	Regazzi M， Joseè G， Molinaro M. Monoclonal antibody monitoring： clinically relevant aspects， a systematic critical review［J］. Ther Drug Monit， 2019， 42（1）： 1. doi： 10.1097/FTD.0000000000000681.
[9]	Zhang XL， Miao LY， Chen WQ. The expert consensus on the Standards of Therapeutic Drug Monitoring （2019 Edition）［J］. Eval Anal Drug Use Hosp China（中国医院用药评价与分析）， 2019， 19（8）： 897-898.
[10]	Darrouzain F， Bian SM， Desvignes C， et al. Immunoassays for measuring serum concentrations of monoclonal antibodies and anti-biopharmaceutical antibodies in patients［J］. Ther Drug Monit， 2017， 39（4）： 316-321.
[11]	Bloem K， Hernández-Breijo B， Martínez-Feito A， et al. Immunogenicity of therapeutic antibodies： monitoring antidrug antibodies in a clinical context［J］. Ther Drug Monit， 2017， 39（4）： 327-332.
[12]	Zhang SW， Jian WY. Recent advances in absolute quantification of peptides and proteins using LC-MS［J］. Rev Anal Chem， 2014， 33（1）： 31-47.
[13]	Willrich MA， Murray DL， Barnidge DR， et al. Quantitation of infliximab using clonotypic peptides and selective reaction monitoring by LC-MS/MS［J］. Int Immunopharmacol， 2015， 28（1）： 513-520.
[14]	Todoroki K， Mizuno H， Sugiyama E， et al. Bioanalytical methods for therapeutic monoclonal antibodies and antibody-drug conjugates： a review of recent advances and future perspectives［J］. J Pharm Biomed Anal， 2020， 179： 112991.
[15]	van den Broek I， van Dongen WD. LC-MS-based quantification of intact proteins： perspective for clinical and bioanalytical applications［J］. Bioanalysis， 2015， 7（15）： 1943-1958.
[16]	Bults P， Spanov B， Olaleye O， et al. Intact protein bioanalysis by liquid chromatography - High-resolution mass spectrometry［J］. J Chromatogr B Analyt Technol Biomed Life Sci， 2019， 1110/1111： 155-167.
[17]	Kleinnijenhuis AJ， Toersche JH， Frédérique L， et al. A generic sample preparation approach for LC–MS/MS bioanalysis of therapeutic monoclonal antibodies in serum applied to Infliximab［J］. J Appl Bioanal， 2015， 1（1）： 26-34.
[18]	Wang Q， Han JB， Sha CJ， et al. Novel strategy using tryptic peptide immunoaffinity-based LC-MS/MS to quantify denosumab in monkey serum［J］. Bioanalysis， 2017， 9（19）： 1451-1463.
[19]	Peng XY， Liu BN， Li YT， et al. Development and validation of LC-MS/MS method for the quantitation of infliximab in human serum［J］. Chromatographia， 2015， 78（7/8）： 521-531.
[20]	Jenkins R， Duggan JX， Aubry AF， et al. Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics［J］. AAPS J， 2015， 17（1）： 1-16.
[21]	VDGJGrace， Bressler B， Demarco ML. An automated mass spectrometric blood test for therapeutic drug monitoring of infliximab［J］. Clin Mass Spectrom， 2019， 12： 16-22.
[22]	Iwamoto N， Takanashi M， Yokoyama K， et al. Multiplexed monitoring of therapeutic antibodies for inflammatory diseases using Fab-selective proteolysis nSMOL coupled with LC-MS［J］. J Immunol Methods， 2019， 472： 44-54.
[23]	Mouchahoir T， Schiel JE. Development of an LC-MS/MS peptide mapping protocol for the NISTmAb［J］. Anal Bioanal Chem， 2018， 410（8）： 2111-2126.
[24]	Chiu HH， Tsai IL， Lu YS， et al. Development of an LC-MS/MS method with protein G purification strategy for quantifying bevacizumab in human plasma［J］. Anal Bioanal Chem， 2017， 409（28）： 6583-6593.
[25]	Ouyang Z， Furlong MT， Wu S， et al. Pellet digestion： a simple and efficient sample preparation technique for LC-MS/MS quantification of large therapeutic proteins in plasma［J］. Bioanalysis， 2012， 4（1）： 17-28.
[26]	Wilffert D， Bischoff R， van de Merbel NC. Antibody-free workflows for protein quantification by LC-MS/MS［J］. Bioanalysis， 2015， 7（6）： 763-779.
[27]	Mesmin C， Fenaille F， Ezan E， et al. MS-based approaches for studying the pharmacokinetics of protein drugs［J］. Bioanalysis， 2011， 3（5）： 477-480.
[28]	Shibata K， Naito T， Okamura J， et al. Simple and rapid LC-MS/MS method for the absolute determination of cetuximab in human serum using an immobilized trypsin［J］. J Pharm Biomed Anal， 2017， 146： 266-272.
[29]	Echan LA， Tang HY， Ali-Khan N， et al. Depletion of multiple high-abundance proteins improves protein profiling capacities of human serum and plasma［J］. Proteomics， 2005， 5（13）： 3292-3303.
[30]	Liu GW， Zhao Y， Angeles A， et al. A novel and cost effective method of removing excess albumin from plasma/serum samples and its impacts on LC-MS/MS bioanalysis of therapeutic proteins［J］. Anal Chem， 2014， 86（16）： 8336-8343.
[31]	Amrani ME， van den Broek MP， G?bel C， et al. Quantification of active infliximab in human serum with liquid chromatography-tandem mass spectrometry using a tumor necrosis factor alpha-based pre-analytical sample purification and a stable isotopic labeled infliximab bio-similar as internal standard： a target-based， sensitive and cost-effective method［J］. J Chromatogr A， 2016， 1454： 42-48.
[32]	Vialaret J， Broutin S， Pugnier C， et al. What sample preparation should be chosen for targeted MS monoclonal antibody quantification in human serum ［J］？ Bioanalysis， 2018， 10（10）： 723-735.
[33]	Chiu HH， Liao HW， Shao YY， et al. Development of a general method for quantifying IgG-based therapeutic monoclonal antibodies in human plasma using protein G purification coupled with a two internal standard calibration strategy using LC-MS/MS［J］. Anal Chim Acta， 2018， 1019： 93-102.
[34]	Dubois M， Fenaille F， Clement G， et al. Immunopurification and mass spectrometric quantification of the active form of a chimeric therapeutic antibody in human serum［J］. Anal Chem， 2008， 80（5）： 1737-1745.
[35]	van den Broek I， Niessen WM， van Dongen WD. Bioanalytical LC-MS/MS of protein-based biopharmaceuticals［J］. J Chromatogr B Analyt Technol Biomed Life Sci， 2013， 929： 161-179.
[36]	Jourdil JF， Lebert D， Gautier-Veyret E， et al. Infliximab quantitation in human plasma by liquid chromatography-tandem mass spectrometry： towards a standardization of the methods［J］？Anal Bioanal Chem， 2017， 409（5）： 1195-1205.
[37]	Zheng J， Mehl J， Zhu YX， et al. Application and challenges in using LC-MS assays for absolute quantitative analysis of therapeutic proteins in drug discovery［J］. Bioanalysis， 2014， 6（6）： 859-879.
[38]	Vasicek LA， Spellman DS， Hseih SC， et al. Quantitation of a therapeutic antibody in serum using intact sequential affinity capture， trypsin digestion and LC-MS/MS［J］. Anal Chem， 2018， 90（1）： 866-871.
[39]	Nouri-Nigjeh E， Zhang M， Ji T， et al. Effects of calibration approaches on the accuracy for LC-MS targeted quantification of therapeutic protein［J］. Anal Chem， 2014， 86（7）： 3575-3584.
[40]	Damen CW， de Groot ER， Heij M， et al. Development and validation of an enzyme-linked immunosorbent assay for the quantification of trastuzumab in human serum and plasma［J］. Anal Biochem， 2009， 391（2）： 114-120.
[41]	Gui LL， Li L， Dong LH， et al. Method development and validation of LC-MS/MS-based assay for the simultaneous quantitation of trastuzumab and pertuzumab in cynomolgus monkey serum and its application in pharmacokinetic study［J］. Biomed Chromatogr， 2020， 34（12）： e4903. doi： 10.1002/bmc.4903.
[42]	Willeman T， Jourdil JF， Gautier-Veyret E， et al. A multiplex liquid chromatography tandem mass spectrometry method for the quantification of seven therapeutic monoclonal antibodies： Application for adalimumab therapeutic drug monitoring in patients with Crohn's disease［J］. Anal Chim Acta， 2019， 1067： 63-70.
[43]	Hahne H， Pachl F， Ruprecht B， et al. DMSO enhances electrospray response， boosting sensitivity of proteomic experiments［J］. Nat Methods， 2013， 10（10）： 989-991.
[44]	Zheng J， Mehl J， Zhu YX， et al. Application and challenges in using LC-MS assays for absolute quantitative analysis of therapeutic proteins in drug discovery［J］. Bioanalysis， 2014， 6（6）： 859-879.
[45]	Bronsema KJ， Bischoff R， Pijnappel WW， et al. Absolute quantification of the total and antidrug antibody-bound concentrations of recombinant human α-glucosidase in human plasma using protein G extraction and LC-MS/MS［J］. Anal Chem， 2015， 87（8）： 4394-4401.
[46]	Rai AJ， Gelfand CA， Haywood BC， et al. HUPO Plasma Proteome Project specimen collection and handling： towards the standardization of parameters for plasma proteome samples［J］. Proteomics， 2005， 5（13）： 3262-3277.
[47]	Zhou N， Wang J， Ding L. Common issues and counterplans on LC-MS analysis of peptides and proteins in bio-samples［J］. J China Pharm Univ（中国药科大学学报）， 2010，41（5）： 401-407.
[48]	Zhang HW， Xin BM， Caporuscio C， et al. Bioanalytical strategies for developing highly sensitive liquid chromatography/tandem mass spectrometry based methods for the peptide GLP-1 agonists in support of discovery PK/PD studies［J］. Rapid Commun Mass Spectrom， 2011， 25（22）： 3427-3435.
[49]	Ji QC， Rodila R， El-Shourbagy TA. A sample preparation process for LC-MS/MS analysis of total protein drug concentrations in monkey plasma samples with antibody［J］. J Chromatogr B Analyt Technol Biomed Life Sci， 2007， 847（2）： 133-141.

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