Fully validated LCMS bioanalysis of Bevacizumab in human plasma using nano-surface and molecular-orientation limited (nSMOL) proteolysis

Drug Metabolism and Pharmacokinetics
Noriko IwamotoTakashi Shimada

Abstract

The chemistry of nano-surface and molecular-orientation limited (nSMOL) proteolysis is the Fab-selective limited proteolysis by making use the difference of protease nanoparticle diameter (200 nm) and antibody resin pore diameter (100 nm). In this report, we have demonstrated that the full validation for Bevacizumab bioanalysis in human plasma using nSMOL. The immunoglobulin fraction was collected by Protein A resin from plasma, then nSMOL reaction was performed using the FG nanoparticle-immobilized trypsin under the nondenaturing physiological condition at 50 °C for 6 h. After removal of resin and nanoparticles, the signature peptide of Bevacizumab complementarity-determining region (CDR) and internal standard P14R were simultaneously quantified by LCMS multiple reaction monitoring (MRM). This nSMOL method quantification of Bevacizumab showed sensitivity of 0.146 μg/ml and linearity of 0.146-300 μg/ml. The intra- and inter-assay precision of lower limit of quantification (LLOQ), low quality control (LQC), middle quality control (MQC), and high quality control (HQC) was 7.94-15.2% and 14.6%, 7.15-13.5% and 11.7%, 2.63-6.47% and 5.83%, and 3.09-4.35% and 4.45%, respectively. These results indicate that nSMOL is also significant ...Continue Reading

Citations

Jan 4, 2020·Analytical and Bioanalytical Chemistry·Linlin KongFei Yu
Oct 1, 2017·Analytical and Bioanalytical Chemistry·Huai-Hsuan ChiuChing-Hua Kuo
Mar 3, 2019·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Tomohiro YamadaKenichiro Todoroki
Jan 2, 2021·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Mayu OhuchiAkinobu Hamada
Jan 29, 2021·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Catherine E DelGuidiceMatthew S Halquist
Jul 27, 2021·Drug Metabolism Reviews·Aarzoo ThakurChukwunonso K Nwabufo

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