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Liquid chromatography-tandem mass spectrometry method for detection of toripalimab drug concentration in human plasma based on characteristic peptides

A technology of toripalimab and tandem mass spectrometry, applied in the field of determination of the drug concentration of toripalimab, can solve the problems of high sample dilution, long antigen or antibody cycle, and susceptibility to matrix interference, etc.

Active Publication Date: 2022-07-26
PEKING UNION MEDICAL COLLEGE HOSPITAL CHINESE ACAD OF MEDICAL SCI +1
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

However, the ECLIA method has certain limitations, such as a long cycle to obtain specific antigens or antibodies, high sample dilution factor, narrow linear range (generally less than two orders of magnitude), poor precision, susceptible to matrix interference, and crossover. reaction etc.

Method used

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  • Liquid chromatography-tandem mass spectrometry method for detection of toripalimab drug concentration in human plasma based on characteristic peptides
  • Liquid chromatography-tandem mass spectrometry method for detection of toripalimab drug concentration in human plasma based on characteristic peptides
  • Liquid chromatography-tandem mass spectrometry method for detection of toripalimab drug concentration in human plasma based on characteristic peptides

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Embodiment Construction

[0028] 1 Overview

[0029] In order to establish a method for determining the concentration of toripalimab by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS), the inventors first studied toripalimab. The complex components of biological samples may seriously interfere with the accurate quantification of mAbs in the samples to be tested, and it is particularly important to obtain characteristic peptides that can represent the mAbs to be tested. The selected peptides need to have stability (eg, avoid peptides that are prone to modification), specificity, and reduce interference from sample components. The inventors screened various peptide fragments after enzymatic hydrolysis of toripalimab, obtained the characteristic peptide fragment ASGYTFTDYEMHWVR, and then synthesized the extended isotope internal standard CKASGYTFTDYEMHWVR* based on the characteristic peptide fragment. Plasma samples were denatured, reduced, alkylated, enzymatically hydrolyze...

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Abstract

This paper relates to a liquid chromatography-tandem mass spectrometry method for the detection of toripalimab drug concentrations in human plasma based on characteristic peptides. Provided herein is a method for the determination of toripalimab concentration by ultra-performance liquid chromatography tandem mass spectrometry (UPLC‑MS / MS), wherein the method uses ASGYTFTDYEMHWVR as the characteristic peptide for the determination. The method of the invention is simple and fast, has short development period and good repeatability.

Description

technical field [0001] The present invention relates to methods for detecting drug concentrations. Specifically, the present invention relates to a method for determining the drug concentration of Toripalimab by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS). Background technique [0002] introduction [0003] Programmed cell death protein-1 (PD-1) and its ligand (programmed cell death protein ligand-1, PD-L1) are a pair of immune co-stimulatory molecules, PD-1 is mainly expressed in On the surface of activated T cells, tumor cells express their ligand PD-L1 and bind to PD-1 to inhibit the activation of T cells, inhibit the body's anti-tumor immune response, and achieve immune escape [1]. Monoclonal antibody drugs targeting PD-1 / PD-L1 can block the combination of PD-L1 and PD-1, thereby enhancing the anti-tumor activity of immune cells and promoting the immune clearance of tumor cells. It has shown good clinical efficacy response and surviva...

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/72G01N33/68
CPCG01N30/02G01N30/06G01N30/72G01N33/6848G01N2030/067
Inventor 韩晓红石远凯刘书霞
Owner PEKING UNION MEDICAL COLLEGE HOSPITAL CHINESE ACAD OF MEDICAL SCI
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