In Vitro Antigen Immunogenicity Assessment via Neutralization Titer

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Solution Overview

Problem

Current methods for determining the immunogenicity of antigens are limited, as they primarily assess antibody binding without confirming the induction of neutralizing antibodies, and require animal testing, which is complex and raises ethical concerns.

Innovation Solution

A procedure for in vitro determination of antigen immunogenicity, involving the selection of molecules through adsorption with a molecular mix containing specific antibodies, followed by a neutralization test to assess immunogenicity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If animal testing is used to determine immunogenicity, then reliable results on protective immune response can be obtained, but the testing becomes complex and time-consuming

Engineering Contradiction:
Improveimmunogenicity determination accuracyVSAvoidtesting complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent creates an in vitro copy of the in vivo immune response by using recombinant antibodies that specifically bind to neutralizing epitopes. Instead of relying on complex animal models, the method copies the essential protective immune mechanism (neutralizing antibody formation) in a simplified cellular system, thereby maintaining reliability while reducing complexity

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent introduces neutralizing epitopes and recombinant antibodies as intermediaries between the antigen and the immune response assessment. These intermediaries allow direct measurement of protective immunity in vitro without needing complex animal models, resolving the contradiction between reliability and complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If animal testing is used to determine immunogenicity, then protective immune response can be assessed, but ethical concerns arise and usage is restricted

Engineering Contradiction:
Improveimmunogenicity determination accuracyVSAvoidethical concerns
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the biological mechanical system of animal testing with a biochemical system using recombinant antibodies and epitope binding assays. This substitution eliminates ethical concerns about animal usage while maintaining the ability to assess protective immune responses through direct measurement of neutralizing antibody binding

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

3Productivity

If only antibody binding capacity is assessed, then epitope mapping can be performed, but no statement can be made about induction of protective neutralizing antibodies

Engineering Contradiction:
Improveepitope mapping efficiencyVSAvoidimmunogenicity assessment accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies local quality by specifically targeting neutralizing epitopes with recombinant antibodies rather than assessing all epitopes equally. This focused approach on the functionally critical neutralizing epitopes provides precise measurement of immunogenicity while maintaining efficient epitope mapping of the most relevant regions

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent creates a specific copy of the protective immune mechanism by using recombinant antibodies that mimic neutralizing antibodies. This allows direct assessment of whether an antigen induces protective immunity, going beyond simple binding capacity to measure actual immunogenicity with high precision

Inventive Principle:
Principle #26Copying

4Device complexity

If in vitro methods are used to determine immunogenicity, then animal testing can be eliminated, but reliable assessment of protective immune response becomes difficult

Engineering Contradiction:
Improvetesting complexityVSAvoidimmunogenicity determination accuracy
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent successfully copies the essential protective immune response mechanism in vitro by using recombinant antibodies that bind to neutralizing epitopes. This copying approach allows reliable assessment of immunogenicity in a simplified in vitro system, eliminating the need for complex animal models while maintaining measurement accuracy

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent uses neutralizing epitopes and recombinant antibodies as intermediaries to bridge the gap between simple in vitro binding assays and complex in vivo immune responses. These intermediaries enable reliable immunogenicity assessment in vitro by directly measuring the capacity to induce protective neutralizing antibodies

Inventive Principle:
Principle #24Intermediary (Mediator)

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

This method allows for the in vitro assessment of antigen immunogenicity, eliminating the need for animal testing and providing a reliable measure of the ability to induce neutralizing antibodies.

Implementation Method 1

selecting at least one first molecule by incubating the test antigen with a molecule mixture containing the at least one first molecule and at least one second molecule to enable adsorption of the at least one first molecule or the at least one second molecule onto the test antigen

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentEP4549940A1Method for determining the immunogenicity of an antigen
Publication Date: 2025.05.07 UNIVERSITÄT LEIPZIG KÖRPERSCHAFT DES ÖFFENTLICHEN RECHTS
  • EP4549940A1 patent drawingFigure 1
  • EP4549940A1 patent drawingFigure 2
  • EP4549940A1 patent drawing

AI summary

The invention relates to a method for the in vitro determination of the immunogenicity of a first antigen, referred to as the test antigen, wherein the method comprises: (a) selecting at least one first molecule by incubating the test antigen with a mixture of molecules containing the at least one first molecule and at least one second molecule to enable the adsorption of the at least one first molecule or the at least one second molecule to the test antigen; (b) performing a neutralization test using a second antigen, referred to as the target antigen, and using the at least one first molecule selected in step (a) to obtain a neutralization titer; and (c) determining the immunogenicity of the test antigen using the neutralization titer obtained in step (b).