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

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. An ELISA was developed and val...

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Bibliographic Details
Published in:Bioanalysis 2021-04, Vol.13 (7), p.565-574
Main Authors: Desvignes, Céline, Ternant, David, Lecomte, Thierry, Lièvre, Astrid, Ohresser, Marc, Chautard, Romain, Raoul, William, Paintaud, Gilles
Format: Article
Language:English
Subjects:
Biochemistry
Biochemistry, Molecular Biology
Biotechnology
Cancer
enzyme-linked immunosorbent assay
Life Sciences
monoclonal antibody
Pharmaceutical sciences
pharmacokinetics
Pharmacology
ramucirumab
therapeutic drug monitoring
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Summary: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. 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. This in-house-developed ELISA is sensitive, accurate, reproducible and suitable for pharmacokinetic studies of ramucirumab.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2020-0199