A robust enzyme-linked immunosorbent assay to measure serum ramucirumab concentrations

被引：2

作者：

Desvignes, Celine ^{[1
,2
]}

Ternant, David ^{[1
,2
,3
]}

Lecomte, Thierry ^{[4
,5
]}

Lievre, Astrid ^{[6
,7
]}

Ohresser, Marc ^{[2
]}

Chautard, Romain ^{[4
]}

Raoul, William ^{[8
]}

Paintaud, Gilles ^{[1
,2
,3
]}

机构：

[1] CHRU Tours, Ctr Pilote Suivi Biol Traitements Anticorps CePiB, Plateforme Rech, Tours, France

[2] Univ Tours, EA4245 Transplantat, Immunol, Inflammat, Tours, France

[3] CHRU Tours, Serv Pharmacol Med, Tours, France

[4] CHRU Tours, Serv Hepatogastroenterol & Oncol Digest, Tours, France

[5] Univ Tours, Grp Innovat & Ciblage Cellulaire, EA 7501, Tours, France

[6] CHU Pontchaillou, Serv Gastroenterol, Rennes, France

[7] INSERM, U1242, Oncogenesis Stress & Signaling, Rennes, France

[8] Univ Tours, INSERM, UMR 1069, Nutr Croissance & Canc N2C, Tours, France

来源：

BIOANALYSIS | 2021年 / 13卷 / 07期

关键词：

enzyme-linked immunosorbent assay; monoclonal antibody; pharmacokinetics; ramucirumab; therapeutic drug monitoring;

D O I：

10.4155/bio-2020-0199

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Aim: Ramucirumab, an anti-VEGFR2 monoclonal antibody, has been approved for the treatment of metastatic gastric and colorectal cancer. An assay measuring ramucirumab serum concentrations was needed to investigate its pharmacokinetics and concentration-response relationship. Results: An ELISA was developed and validated according to the international guidelines for ligand-binding assays. Ramucirumab calibration standards ranged from 0.125 to 40 mg/l. Low, middle and high quality controls were spiked at 0.2, 4 and 8 mg/l, respectively. The limits of quantification were established to be 0.125 and 10 mg/l for LLOQ and ULOQ, respectively. No cross-reactivity with anti-VEGF or anti-EGFR was detected. Conclusion: This in-house-developed ELISA is sensitive, accurate, reproducible and suitable for pharmacokinetic studies of ramucirumab.

引用

收藏

页码：565 / 574

页数：10

相关论文

共 38 条

[1] Meta-analysis of individual patient safety data from six randomized, placebo-controlled trials with the antiangiogenic VEGFR2-binding monoclonal antibody ramucirumab [J].

Arnold, D. ;

Fuchs, C. S. ;

Tabernero, J. ;

Ohtsu, A. ;

Zhu, A. X. ;

Garon, E. B. ;

Mackey, J. R. ;

Paz-Ares, L. ;

Baron, A. D. ;

Okusaka, T. ;

Yoshino, T. ;

Yoon, H. H. ;

Das, M. ;

Ferry, D. ;

Zhang, Y. ;

Lin, Y. ;

Binder, P. ;

Sashegyi, A. ;

Chau, I. .

ANNALS OF ONCOLOGY, 2017, 28 (12) :2932-2942

[2] Pharmacokinetic Variability of Therapeutic Antibodies in Humans: A Comprehensive Review of Population Pharmacokinetic Modeling Publications [J].

Bensalem, Amina ;

Ternant, David .

CLINICAL PHARMACOKINETICS, 2020, 59 (07) :857-874

[3]

Booth B., 2013, BIOANALYTICAL METHOD

[4] An Enzyme-Linked Immunosorbent Assay for Therapeutic Drug Monitoring of Cetuximab [J].

Ceze, Nicolas ;

Ternant, David ;

Piller, Friedrich ;

Degenne, Danielle ;

Azzopardi, Nicolas ;

Dorval, Etienne ;

Watier, Herve ;

Lecomte, Thierry ;

Paintaud, Gilles .

THERAPEUTIC DRUG MONITORING, 2009, 31 (05) :597-601

[5] Phase I study of every 2-or 3-week dosing of ramucirumab, a human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2 in patients with advanced solid tumors [J].

Chiorean, E. G. ;

Hurwitz, H. I. ;

Cohen, R. B. ;

Schwartz, J. D. ;

Dalal, R. P. ;

Fox, F. E. ;

Gao, L. ;

Sweeney, C. J. .

ANNALS OF ONCOLOGY, 2015, 26 (06) :1230-1237

[6] Exposure-response relationship of ramucirumab in patients with advanced second-line colorectal cancer: exploratory analysis of the RAISE trial [J].

Cohn, Allen Lee ;

Yoshino, Takayuki ;

Heinemann, Volker ;

Obermannova, Radka ;

Bodoky, Gyorgy ;

Prausova, Jana ;

Garcia-Carbonero, Rocio ;

Ciuleanu, Tudor ;

Garcia-Alfonso, Pilar ;

Portnoy, David C. ;

Van Cutsem, Eric ;

Yamazaki, Kentaro ;

Clingan, Philip R. ;

Polikoff, Jonathon ;

Lonardi, Sara ;

O'Brien, Lisa M. ;

Gao, Ling ;

Yang, Ling ;

Ferry, David ;

Nasroulah, Federico ;

Tabernero, Josep .

CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2017, 80 (03) :599-608

[7] Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules [J].

DeSilva, B ;

Smith, W ;

Weiner, R ;

Kelley, M ;

Smolec, JM ;

Lee, B ;

Khan, M ;

Tacey, R ;

Hill, H ;

Celniker, A .

PHARMACEUTICAL RESEARCH, 2003, 20 (11) :1885-1900

[8] Development and validation of an ELISA to study panitumumab pharmacokinetics [J].

Desvignes, Celine ;

Passot, Christophe ;

Ternant, David ;

Caulet, Morgane ;

Guerineau, Caroline ;

Lecomte, Thierry ;

Paintaud, Gilles .

BIOANALYSIS, 2018, 10 (04) :205-214

[9] Development and validation of an enzyme-linked immunosorbent assay to measure adalimumab concentration [J].

Desvignes, Celine ;

Edupuganti, Soujanya R. ;

Darrouzain, Francois ;

Duveau, Anne-Claire ;

Loercher, Amy ;

Paintaud, Gilles ;

Mulleman, Denis .

BIOANALYSIS, 2015, 7 (10) :1253-1260

[10]

European Medicines Agency, 2015, CYRAMZA EUROPEAN PUB

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