Development and validation of an ELISA to study panitumumab pharmacokinetics.

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 (50mg/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 10mg/l, respectively. Conclusion: This method is validated and can be used to study pharmacokinetics of panitumumab or to perform therapeutic drug monitoring.