Bioclinical Analysis

Solutions for LC/MS Bioanalysis of Antibody Drugs

Separation Science, in collaboration with Shimadzu, offers a series of application notes providing solutions for LC/MS bioanalysis of antibody drugs. Click on the buttons below to download your personal copies.

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nSMOL (nano-Surface and Molecular Orientation Limited proteolysis) is Shimadzu’s proprietary, innovative technique that enables selective proteolysis of the Fab region of monoclonal antibodies. The nSMOL Antibody BA Kit is a ready-to-use reagent kit that dramatically improves the productivity and robustness of LC/MS mAb bioanalysis.

This technique facilitates method development independent of the variety of antibody drugs and achieves a paradigm shift in the bioanalysis of antibody drugs. Furthermore, this is the only method with respect to antibody drugs that has fulfilled the criteria of "Guideline on Bioanalytical Method Validation in Pharmaceutical Development" for low MW drug compounds issued by the Japanese Ministry of Health, Labour and Welfare. Shimadzu also offers optimization methods and protocols, and nSMOL can be applied to clinical research at various institutions.

LCMS Bioanalysis of Antibody Drugs Using Fab-Selective Proteolysis nSMOL - Trastuzumab Analysis

nSMOL_App1This application describes the quantitation of the monoclonal antibody Trastuzumab in blood plasma using nSMOL. The nSMOL assay succeeded in shortening the analysis time by significantly decreasing the noise matrix.

Learning outcome:
Learn how the nSMOL reagent kit in combination with the Shimadzu LCMS-8050/8060 can overcome the disadvantages of other antibody assay methods (e.g. ELIZA), providing a rapid, selective quantitation method.

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LCMS Bioanalysis of Antibody Drugs Using Fab-Selective Proteolysis nSMOL- Part 2 - Bevacizumab Analysis
nSMOL_App2This application describes a method for quantitation of the monoclonal antibody Bevacizumab in blood plasma, in a method similar to the above.

Learning Outcome:
Learn how the nSMOL method allows precise selection of quantitation peptides that reflect the structural characteristics of antibodies.

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LCMS Bioanalysis of Antibody Drugs Using Fab-Selective Proteolysis nSMOL - Part 3 - Nivolumab Analysis
nSMOL_App3This application describes a method for quantitation of the monoclonal antibody Nivolumab in blood plasma, in a method similar to the above.

Learning Outcome:
Learn how Shimadzu’s nSMOL method greatly facilitates the development of assay methods by utilizing Fv-selective reactions.

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LCMS Bioanalysis of Antibody Drugs Using FabSelective Proteolysis nSMOL - Part 4 - Multiplex Analysis
nSMOL_App4In this application, nSMOL was used for simultaneous quantitation of three antibodies in one blood sample. The precision and accuracy of the quantitative values fulfilled the FDA’s validation criteria.

Learning outcome:
Understand how nSMOL supports multiplex analysis and can quantify many antibodies in a single analysis.

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Don't miss out on the latest COVID-19, nitrosamine analysis or oligonucleotide drug analysis applications. Click below for PDFs.

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Click here to access the COVID-19 app notes >>

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Click here to access the nitrosamine analysis app notes >>

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Click here to access the oligonucleotide drug analysis app notes >>

 

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