The drug Certolizumab pegol (trade name Cimzia®) is a tumor necrosis factor alpha (TNFα) blocker and binds to human TNFα with a KD of 90pM. Certolizumab pegol is a recombinant, humanized antibody Fab' fragment, with specificity for TNFα, conjugated to an approximately 40kDa polyethylene glycol (PEG). The Fab' fragment is manufactured in E. coli and is subsequently subjected to purification and conjugation to PEG2MAL40K, to generate Certolizumab pegol. The ImmunoGuide Antibody to Certolizumab pegol ELISA kit has been designed for the measurement of free antibodies against this drug. It does not detect such antibodies which already are bound to the drug.

This ImmunoGuide anti-drug antibody(ies) (ADA) kit is a bridging type ELISA for the determination of free antibodies against the drug Certolizumab pegol in serum and plasma samples. During the first incubation period, ADA in serum or plasma samples are captured by the drug coated on the microtiter wells. After washing away the unbound components from samples, a biotinylated drug conjugate is added and then incubated. ADA, if present in sample, will make a bridge, with its identical Fab arms, between the drug coated on the well and the other drug molecule labelled with biotin. Following incubation, wells are washed, and the horseradish peroxidase (HRP)-conjugated streptavidin is added and binds to the biotinylated Certolizumab pegol. Following incubation, wells are washed, and the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen-substrate. Finally, the reaction is terminated with stop solution. The positive reaction is expected to be related to the presence of ADA in the sample.

Anti-Certolizumab pegol (Cimzia®) ELISA

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