Pharmacokinetic Analysis of the mIgG1 anti-ICOS Antibody
For pharmacokinetic analysis of the mIgG1 anti-ICOS antibody (7E.17G9) in EMT6 tumor-bearing mice, serum was collected at 1-hour postdose and both predose and 1-hour postdose at 72 and 144 hours for characterization of antibody presence. Briefly, biotinylated mouse ICOS protein was utilized as the capture reagent and anti-mouse IgG as the detection antibody. Approximately 3 μL of mouse serum was diluted 1/10 with Rexxip A buffer (Gyros Protein Technologies AB) and captured using plate-bound mouse ICOS. The lower limit of quantification was 100 ng/mL, and the higher limit of quantification was 10,000 ng/mL. Quality control samples were stored with study samples and analyzed with each batch of samples against separately prepared calibration standards. At least four of six quality control results and at least 50% of the results from each quality control concentration were required to not deviate from the nominal concentration by more than 25%.