John Smeraglia1, John-Paul Silva2, Kieran Jones3. 1. UCB Pharma, Department of Bioanalytical Sciences, Braine-L'Alleud, Belgium. 2. UCB Pharma, Antibody Discovery Department, Slough, UK. 3. UCB Pharma, Department of Bioanalytical Sciences, Slough, UK.
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.
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.
Authors: Megan Eb Clowse; Frauke Förger; Caroline Hwang; John Thorp; Radboud Jem Dolhain; Astrid van Tubergen; Laura Shaughnessy; Jeff Simpson; Marie Teil; Nathalie Toublanc; Maggie Wang; Thomas W Hale Journal: Ann Rheum Dis Date: 2017-08-16 Impact factor: 19.103
Authors: Xavier Mariette; Frauke Förger; Bincy Abraham; Ann D Flynn; Anna Moltó; René-Marc Flipo; Astrid van Tubergen; Laura Shaughnessy; Jeff Simpson; Marie Teil; Eric Helmer; Maggie Wang; Eliza F Chakravarty Journal: Ann Rheum Dis Date: 2017-10-13 Impact factor: 19.103