LC-MS/MS Bioanalysis of Trastuzumab Using Fab-Selective Proteolysis ‘nSMOL’

by | Pharmaceutical

Shimadzu has produced an application note demonstrating how the LC-MS/MS bioanalysis of antibody drugs has been significantly simplified by this unique nSMOL technology. In this application, the analysis of Trastuzumab is discussed. 

Shimadzu_MIC_trastuzumab_analysis.pngIntroduction
One of the greatest benefits of antibody drugs is the safety as this same molecule constitutes our natural defence system against antigens. However, this benefit turns into a barrier to efficient bioanalysis; methodology is needed to selectively detect administered antibody without interference from host-derived antibodies. Although LC-MS/MS is expected to be the alternative to the conventional ELISA technique for its robustness and ease of method development, strong ionization suppression exerted by high-abundance peptides derived from the constant (Fc) region limits the sensitivity of low-abundance peptides in the variable (Fab) region.

analysis-of-trastuzumab.pngWhat is nSMOL technology?
Nano-surface and molecular orientation limited proteolysis (nSMOL™) is Shimadzu’s proprietary, innovative technology that enables selective proteolysis of the Fab region of antibodies. Peptide sample prepared by the nSMOL kit has a substantially lower complexity near-zero interference from host antibodies, thus enabling LC-MS/MS sensitivity to reach down to the level required for pre-clinical and clinical studies. This application news reports the fully-validated LC-MS/MS method developed for Trastuzumab determination in plasma.

By downloading this application note you will learn:

  • how LC-MS/MS bioanalysis of antibody drugs can be significantly simplified by this unique nSMOL technology

Published  Aug 31, 2017

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