Monodisperse Polyol Linkers for Uniform Analyte Detection

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Solution Overview

Problem

Existing polymer-based linkers, such as PEG, exhibit polydispersity and solubility issues, complicating the analysis and uniformity of conjugates used in analyte detection assays.

Innovation Solution

Development of monodisperse linker molecules with polyols that enhance hydrophilicity and stability, forming complexes with analyte-specific binding agents and label compounds to improve signal-to-noise ratio in analyte detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If PEG-based linkers are used for conjugation, then hydrophilicity is improved, but polydispersity increases and solubility becomes insufficient

Engineering Contradiction:
ImprovehydrophilicityVSAvoidpolydispersity
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The patent changes the chemical structure parameters of the linker by replacing PEG-based polymers with defined polyol-based small molecules. This structural parameter change eliminates polydispersity while maintaining hydrophilicity through multiple hydroxyl groups, directly resolving the contradiction between hydrophilicity and manufacturing precision

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses homogenous polyol-based linkers with uniform molecular weight and structure instead of polydisperse PEG polymers. This homogeneity ensures consistent conjugate properties and eliminates the solubility issues associated with mixed molecular weights, resolving the contradiction between hydrophilicity and manufacturing precision

Inventive Principle:
Principle #33Homogeneity

2Object-affected harmful factors

If PEG-based linkers are used for conjugation, then hydrophilicity is improved, but conjugate solubility becomes insufficient

Engineering Contradiction:
ImprovehydrophilicityVSAvoidconjugate solubility
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent changes the molecular weight parameter to a single uniform value rather than a distribution, and modifies the chemical structure to include multiple hydroxyl groups. This parameter change enhances water solubility through increased hydrogen bonding capability while eliminating the solubility problems caused by polydispersity, resolving the contradiction between hydrophilicity and conjugate solubility

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If polysaccharides are used as linkers, then hydrophilicity is improved, but structural uniformity decreases due to complexity

Engineering Contradiction:
ImprovehydrophilicityVSAvoidstructural uniformity
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The patent extracts the essential hydrophilic functionality (multiple hydroxyl groups) from complex polysaccharide structures and implements it in simplified polyol-based linkers. This extraction maintains the hydrophilicity benefit while eliminating the structural complexity and variability inherent in polysaccharides, resolving the contradiction between hydrophilicity and structural uniformity

Inventive Principle:
Principle #2Taking out (Extraction)

4Ease of manufacture

If polydisperse linkers are used, then ease of manufacture is improved, but analysis complexity increases

Engineering Contradiction:
Improveease of manufactureVSAvoidanalysis complexity
Core Design Contradiction:
Ease of manufactureVSDifficulty of detecting and measuring

Solution Approach 1:

The patent changes the molecular weight parameter from a distribution to a single uniform value, and changes the chemical structure to a well-defined polyol-based small molecule. This parameter change simplifies analytical characterization while maintaining ease of manufacture through available synthetic methods, resolving the contradiction between ease of manufacture and analysis complexity

Inventive Principle:
Principle #35Parameter changes

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 use of monodisperse polyol linkers results in stable complexes with improved signal-to-noise ratio and simplified product purification, enhancing the reproducibility and uniformity of analyte detection assays.

Implementation Method 1

the label compound is capable of producing a detectable signal, preferably a chemiluminescence based signal, more preferably an electrochemiluminescence based signal

Methodology Applied
Scientific EffectChemiluminescence: Chemiluminescence

Implementation Method 2

the label compound is capable of producing a detectable signal, preferably a chemiluminescence based signal, more preferably an electrochemiluminescence based signal

Methodology Applied
Scientific EffectElectrochemiluminescence: Electrochemiluminescence

Implementation Method 3

certain linker molecules with polyols not only offer superior hydrophilicity over PEG-containing derivatives

Methodology Applied
Scientific EffectHydrophilicity: Hydrophile

Data Source

PatentUS20250237656A1Method for detecting an analyte of interest in a sample
Publication Date: 2025.07.24 ROCHE DIAGNOSTICS OPERATIONS INC
  • US20250237656A1 patent drawing
  • US20250237656A1 patent drawing
  • US20250237656A1 patent drawing

AI summary

The present invention relates to a method for determining at least one analyte of interest and the use thereof. The present invention further relates to a kit, a complex, a method to synthesize a complex, a monomer and the use thereof for detecting the analyte of interest in the sample.