Biotin-Specific Monoclonal Antibody for Free Biotin Assay Interference

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Solution Overview

Problem

Existing monoclonal antibodies either bind to both free biotin and biotinylated molecules or only to biotinylated molecules, lacking specificity for free biotin and high affinity differential binding.

Innovation Solution

Development of a monoclonal antibody that specifically binds to biotin via its valeric acid moiety, avoiding interaction with the heterocyclic structure, and exhibits a higher affinity for free biotin compared to biotinylated forms by a factor of at least 50 to 100,000.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing monoclonal antibodies are used to bind biotin, then they can bind to biotinylated molecules, but they also bind to free biotin causing interference in assays

Engineering Contradiction:
Improveassay accuracyVSAvoidinterference from free biotin
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent segments the biotin binding capability by creating distinct antibody populations: one that binds only biotinylated molecules (via the heterocyclic ring) and another that binds only free biotin (via the valeric acid side chain). This segmentation allows selective use of the appropriate antibody depending on assay requirements, eliminating cross-interference

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a blocking agent (such as free biotin, avidin, or streptavidin) as an intermediary to prevent unwanted interactions. The blocking agent selectively binds to free biotin in the sample, preventing it from interfering with the detection of biotinylated analytes, thereby improving assay reliability

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If monoclonal antibodies target the heterocyclic structure of biotin, then they bind to biotinylated molecules, but they lose specificity for free biotin

Engineering Contradiction:
Improvebinding specificityVSAvoidbinding range
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent applies local quality by directing antibody specificity to different local regions of the biotin molecule. Antibodies are engineered to recognize either the heterocyclic ring region (for biotinylated molecule detection) or the valeric acid side chain region (for free biotin detection), allowing each antibody to excel at its designated target with high precision

Inventive Principle:
Principle #3Local quality

3Measurement precision

If high affinity binding to biotin is achieved, then detection sensitivity improves, but cross-reactivity with biotinylated molecules increases

Engineering Contradiction:
Improvedetection sensitivityVSAvoidcross-reactivity
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent inverts the conventional approach by developing antibodies with high affinity for free biotin (rather than biotinylated molecules). This inverted strategy allows the use of such antibodies in assay blocks where free biotin needs to be sequestered, turning what was previously a source of interference into a useful blocking mechanism

Inventive Principle:
Principle #13The other way round (Inversion)

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

The antibody effectively reduces interference from high biotin levels in assays by selectively binding free biotin, minimizing cross-reactivity with biotinylated molecules and enhancing assay accuracy.

Implementation Method 1

a monoclonal antibody which specifically binds biotin, wherein it does not bind a biotin moiety on a biotinylated molecule

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

wherein a (strept)avidin/biotin pair is used to bind a biotinylated analyte specific binding agent to a (strept)avidin coated solid phase

Methodology Applied
Scientific EffectAvidin-biotin binding:

Data Source

PatentEP3562841B1Novel biotin-specific monoclonal antibody and use thereof
Publication Date: 2026.03.25 F HOFFMANN LA ROCHE & CO AG
  • EP3562841B1 patent drawingFigure 1A~1B
  • EP3562841B1 patent drawingFigure 2
  • EP3562841B1 patent drawingFigure 2B

AI summary

The present invention relates to a monoclonal antibody capable of binding to biotin. In one embodiment the monoclonal antibody according to the invention also does not bind to a biotin moiety on a biotinylated molecule, wherein the biotin moiety is attached to the molecule via the carbon atom of the carboxyl function of the valeric acid moiety of biotin. Also disclosed is a method for generation of an antibody as disclosed herein. The monoclonal antibody according to the invention is of specific use in a method for measuring an analyte in a sample, wherein a (strept)avidin/biotin pair is used to bind a biotinylated analyte specific binding agent to a (strept)avidin coated solid phase.