A robust enzyme-linked immunosorbent assay to measure serum ramucirumab concentrations
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Published on: September 10, 2018
Céline Desvignes1,2, David Ternant1,2,3, Thierry Lecomte4,5
1CHRU de Tours, Plateforme Recherche, Centre Pilote de Suivi Biologique des Traitements par Anticorps (CePiBAc), Tours, France.
Abstract:
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.
