Method for identifying and quantifying polysaccharides in complex carbohydrate compositions.

The LC-MS system directly analyzes glycoproteins to quantify polysaccharides without sample preparation, addressing the inefficiencies of current methods and enabling rapid, cost-effective, and accurate analysis of glycoprotein-based drugs.

JP2026086395APending Publication Date: 2026-05-26JANSSEN PHARMACEUTICALS INC
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Patent Information

Application Number
JP2025280376
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-01-28
Filing Date
2025-12-24
Publication Date
2026-05-26

AI Technical Summary

Technical Problem

Current methods for analyzing complex carbohydrate compositions, particularly glycoproteins, are time-intensive and costly due to the need for multiple assays and sample preparation, which complicates the analysis and delays the release of glycoprotein-based drugs, and lack the ability to provide absolute quantification and simultaneous analysis of multiple release criteria.

Method used

An LC-MS system is used to analyze glycoproteins in their natural state without enzymatic release, enabling direct identification and absolute quantification of polysaccharides through in-source fragmentation and calibration curves, allowing for the integration of multiple release criteria into a single assay.

Benefits of technology

This method significantly reduces analysis time and cost by eliminating sample preparation steps, providing accurate and rapid quantification of polysaccharides, thereby enhancing the throughput and quality control of glycoprotein-based drugs.

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Abstract

There is a need for analytical methods to identify and quantify complex carbohydrate compositions, particularly methods using liquid chromatography-mass spectrometry ("LC-MS systems") to analyze the polysaccharide components of glycoproteins in samples. For example, there is a demand for the use of LC-MS systems in process control during the production of complex carbohydrates. [Solution] A method for analyzing the polysaccharide components of a glycoprotein in a sample, comprising: identification of the polysaccharide components; and absolute quantification of the polysaccharide components, the method comprising: (a) establishing a calibration curve for the polysaccharide components using an LC-MS system; (b) measuring the sample using the same LC-MS system; and (c) comparing the results of (a) and (b) thereby analyzing and comparing the polysaccharide components in the sample, wherein the glycoprotein is in its natural state.
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