Development and validation of an ELISA to study panitumumab pharmacokinetics

Bioanalysis. 2018 Feb;10(4):205-214. doi: 10.4155/bio-2016-0292. Epub 2018 Jan 18.


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.

Keywords: ELISA; monoclonal antibody; panitumumab; pharmacokinetics; therapeutic drug monitoring.

Publication types

  • Validation Study

MeSH terms

  • Antibodies, Monoclonal / blood
  • Antibodies, Monoclonal / pharmacokinetics*
  • Antibodies, Monoclonal / therapeutic use
  • Antineoplastic Agents / blood
  • Antineoplastic Agents / pharmacokinetics*
  • Antineoplastic Agents / therapeutic use
  • Colorectal Neoplasms / drug therapy
  • Cross Reactions
  • Dose-Response Relationship, Drug
  • Drug Monitoring
  • Enzyme-Linked Immunosorbent Assay*
  • ErbB Receptors / antagonists & inhibitors
  • ErbB Receptors / immunology
  • Female
  • Humans
  • Limit of Detection
  • Male
  • Panitumumab


  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • Panitumumab
  • ErbB Receptors