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Development and validation of an ELISA to study panitumumab pharmacokinetics
Céline Desvignes1,2, Christophe Passot1,2, David Ternant1,2
1Université François Rabelais de Tours, CNRS UMR 7292 GICC, Tours, France.
Aim:
Panitumumab is a monoclonal antibody directed against EGFR that is approved for the treatment of metastatic colorectal cancer. To investigate its pharmacokinetics and concentration-response relationship, a validated assay is required.
Results:
An ELISA assay was developed and validated according to international recommendations. Six calibrators (ranging from 0.1 to 20 mg/l) plus one anchor point (50 mg/l) and three quality controls (0.45, 2 and 8 mg/l) were defined. The limit of detection, lower limit of quantification and upper limit of quantification were 0.033, 0.112 and 10 mg/l, respectively.
Conclusion:
This method is validated and can be used to study pharmacokinetics of panitumumab or to perform therapeutic drug monitoring.
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