Improving the sensitivity and specificity of a bioanalytical assay for the measurement of certolizumab pegol. (August 2017)

• Record Type: Journal Article
• Authors: Smeraglia, John; Silva, John-Paul; Jones, Kieran
• Is Part Of: Bioanalysis. Volume 9:Number 16(2017)
• Page Start: 1217
• Page End: 1226
• Publication Date: 2017-08
• Subjects: certolizumab pegol -- electrochemiluminescence -- ELISA -- immunoassay -- placental transfer -- validation; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2017-0124
• Languages: English
• ISSNs: 1757-6180

Abstract

Aim: In order to evaluate placental transfer of certolizumab pegol (CZP), a more sensitive and selective bioanalytical assay was required to accurately measure low CZP concentrations in infant and umbilical cord blood.Results & methodology: A new electrochemiluminescence immunoassay was developed to measure CZP levels in human plasma. Validation experiments demonstrated improved selectivity (no matrix interference observed) and a detection range of 0.032–5.0 μg/ml. Accuracy and precision met acceptance criteria (mean total error ≤20.8%). Dilution linearity and sample stability were acceptable and sufficient to support the method.Conclusion: The electrochemiluminescence immunoassay was validated for measuring low CZP concentrations in human plasma. The method demonstrated a more than tenfold increase in sensitivity compared with previous assays, and improved selectivity for intact CZP.