Evaluation of a biosensor immunoassay for simultaneous characterization of isotype and binding region of human anti-tocilizumab antibodies with control by surrogate standards

Surface plasmon resonance-based methodology for anti-adalimumab antibody identification and kinetic characterization

“…Surface plasmon resonance (SPR)-based optical biosensors have been successfully employed in the evaluation of both the binding and the affinity and/or kinetics of a large number of biomolecular interactions, including those of anti-drug antibodies [23][24][25]. SPR-based optical biosensors detect in real-time mass changes on the chip surface, registering the interaction between the immobilized ligand and the analyte flowing in solution.…”

Cross-reactive and pre-existing antibodies to therapeutic antibodies—Effects on treatment and immunogenicity

“…50 Similarly, pre-dose samples that tested positive for antibodies to tocilizumab were re-tested for antibodies to both Fab and Fc fragments to distinguish specific antibodies from RF. 52,55 Furthermore, traces of aggregates in the drug conjugates used for detection were found to be a major contributor to signals from RF, and removal by size-exclusion chromatography was found to substantially reduce these signals. 51 RF is sometimes removed from serum samples using IgG-coated latex beads.…”

“…Several approaches have been described to circumvent the detection of RF in immunogenicity assays. [50][51][52][53][54] For instance, the use of F(ab')2 fragments of the therapeutic antibody instead of the intact IgG molecules for detection of ADA can effectively eliminate the detection of RF. 50,53,54 However, one should take care not to detect anti-hinge antibodies when using this approach (see below).…”

Tocilizumab: A new anti-rheumatic drug

“…Tocilizumab is administered by intravenous infusions at 8 mg/kg monthly. It is available in preparations with strength of 20 mg/ml (Stubenrauch et al, 2009). …”