Development and validation of an ELISA to study panitumumab pharmacokinetics. (February 2018)

• Record Type: Journal Article
• Authors: Desvignes, Céline; Passot, Christophe; Ternant, David; Caulet, Morgane; Guérineau, Caroline; Lecomte, Thierry; Paintaud, Gilles
• Is Part Of: Bioanalysis. Volume 10:Number 4(2018)
• Page Start: 205
• Page End: 214
• Publication Date: 2018-02
• Subjects: ELISA -- monoclonal antibody -- panitumumab -- pharmacokinetics -- therapeutic drug monitoring; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2016-0292
• Languages: English
• ISSNs: 1757-6180

Abstract

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.