Fc-Binding Protein Antibody Separation for Sugar Chain Detection

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Solution Overview

Problem

Existing methods for analyzing antibody sugar chain structures are complex and cannot distinguish minute structural changes, limiting their ability to detect diseases and aging progression effectively.

Innovation Solution

A method using an Fc-binding protein to separate antibodies based on sugar chain structure differences, involving adsorption on an immobilized carrier and elution with an eluent, to obtain a separation pattern for disease detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If LC-MS analysis including cleavage of sugar chains is performed, then sugar chain structures can be analyzed, but the operations become extremely complicated and require an enormous period of time

Engineering Contradiction:
Improvesugar chain structure analysisVSAvoidoperation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts and utilizes the Fc region of antibodies as a specific target for separation, focusing only on the relevant portion (Fc region with sugar chains) rather than analyzing the entire antibody molecule. This extraction approach simplifies the analysis by concentrating on the critical sugar chain structures that differ between disease states, thereby reducing operational complexity while maintaining measurement precision.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an Fc-binding protein as an intermediary substance that selectively binds to the Fc region of antibodies. This intermediary enables the separation and detection of sugar chain structures through affinity chromatography, transforming the complex direct analysis into a simpler indirect process where the Fc-binding protein mediates the interaction between the antibody Fc region and the detection system.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If chromatography analysis is performed to separate antibodies by molecular weight or charge, then separation can be achieved, but minute structural changes such as sugar chain structure changes cannot be distinguished

Engineering Contradiction:
Improveseparation capabilityVSAvoidstructural change detection
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies local quality by focusing the separation mechanism specifically on the Fc region of antibodies, where sugar chain structures are located. The Fc-binding protein is designed to interact selectively with this specific local region, enabling detection of minute structural changes in sugar chains without being distracted by variations in the rest of the antibody molecule. This localized approach enhances measurement precision for structural changes.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent utilizes parameter changes by employing an Fc-binding protein with specific binding affinity characteristics. The separation is based on changes in binding parameters (affinity, binding strength) rather than physical parameters like molecular weight or charge. This parameter-based separation enables detection of subtle structural changes in sugar chains that alter binding affinity, thereby improving measurement precision for structural analysis.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If existing chromatography methods are used, then antibody separation can be performed, but the methods cannot distinguish minute structural changes and thus provide limited results for disease detection

Engineering Contradiction:
Improveseparation method availabilityVSAvoiddisease detection accuracy
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent introduces an Fc-binding protein as an intermediary that enables reliable detection of disease states through antibody sugar chain analysis. This intermediary substance provides a specific and sensitive mechanism for detecting minute structural changes that are characteristic of disease states, thereby improving reliability for disease detection while maintaining ease of manufacture through a well-defined chromatographic approach.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces conventional mechanical chromatography separation methods (based on molecular weight or charge) with a biochemical interaction-based separation system using Fc-binding protein affinity. This substitution enables the detection of minute structural changes in sugar chains that are invisible to conventional methods, thereby improving reliability for disease detection while keeping the system manufacturable through standard biochemical techniques.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables the detection of diseases and aging progression by analyzing the separation pattern of antibodies, providing a simpler and more effective method for disease diagnosis.

Implementation Method 1

adding a solution containing an antibody obtained from the subject to a column filled with an insoluble carrier on which an Fc-binding protein is immobilized, to allow the antibody(ies) to be adsorbed on the carrier

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

eluting the antibody(ies) adsorbed on the carrier using an eluent, to obtain the data

Methodology Applied
Scientific EffectElution: Desorption

Data Source

PatentUS12372517B2Method for separating antibody, and method for testing on disease
Publication Date: 2025.07.29 TOSOH CORP
  • US12372517B2 patent drawing
  • US12372517B2 patent drawing
  • US12372517B2 patent drawing

AI summary

An object of the present invention is to provide a method for detecting the presence or absence of a disease, the risk of developing a disease, the degree of progression of a disease and/or the degree of progression of aging, in a subject. The present invention achieves the above described object by a method including the following steps (a) to (c): (a) adding a solution containing an antibody obtained from a subject to a column filled with an insoluble carrier on which an Fc-binding protein is immobilized, to allow the antibody to be adsorbed on the carrier; (b) eluting the antibody adsorbed on the carrier using an eluent, to obtain data of a separation pattern of the antibody; and (c) detecting the presence or absence of a disease, the risk of developing a disease, the degree of progression of a disease and/or the degree of progression of aging, in the subject, using the data as an indicator.