A new approach for pharmacokinetics of single-dose cetuximab in rhesus monkeys by surface plasmon resonance biosensor

Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models

“…In single injection of Erbitux, the pharmacokinetics was similar to the present study, which was also applied as a biosimilar on monkeys 7 . In the dosages ranging from 7.5 to 75 mg/kg in rhesus monkeys studies, Erbitux injection did not cause severe side-effects 7,8 . As reported by researches on Erbitux or its biosimilars, they reported that Erbitux did not cause vital organs pathological alterations, except rarely reported heart associated heart failure and increased heart beating rate 9 .…”

Development of a Gold Nanoparticle–Functionalized Surface Plasmon Resonance Assay for the Sensitive Detection of Monoclonal Antibodies and Its Application in Pharmacokinetics

“…Depending on the SPR system, the sensitivity and curve dynamic range reached can be lower than those of microplate-based ELISA methods. In previous works, we proved that the LLOQ of the NP-free SPR-based assay was only 0.05 mg/ml (Che et al, 2009). Improvement of the SPR sensitivity and curve dynamic range can be accomplished by different strategies.…”

“…The established method was validated for a calibration curve, sensitivity, matrix effects, precision, accuracy, and stability, according to the Food and Drug Administration guidelines for bioanalytical method validation. The calibration curve for C225 ranging from 0.0125 to 3.2 mg/ml in 20% monkey serum was generated by plotting the Biacore response of the analyte versus the nominal concentration and fitted by a four-parameter sigmoidal model, as described in our previous work (Che et al, 2009). C225 at concentrations of 0.025, 0.4, and 1.6 mg/ml were set as the low, middle, and high quality control (QC) samples, respectively.…”

“…Biomolecular interaction analysis from Biacore using the optical SPR phenomenon can measure biomolecules in real time without requiring labeling or pretreatment (Fee, 2013;Olaru et al, 2015). Our group first reported a method for the quantification of C255 (cetuximab), a mAb (IgG1) directed at the extracellular domain of the receptor and further pharmacokinetic analysis of monkey serum using the Biacore system (Che et al, 2009). Although automated and accurate analysis was achieved, the relatively low detection sensitivity remained a major disadvantage of the method.…”

“…We elucidated the preclinical pharmacokinetic parameters of cetuximab (C225) in rhesus monkeys after intravenous infusion for the first time using a SPR biosensor-based method (Che et al, 2009). However, the lower limit of quantification (LLOQ) of the method was 0.05 mg/ml.…”