Peanut Allergen Release Profiling by Digestion and Mass Spectrometry

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Solution Overview

Problem

Current methods lack the sensitivity and accuracy to determine the release profiles and allergenic signatures of peanut allergens in therapeutic compositions, particularly at low concentrations, which is crucial for quality control and predicting in vivo effects.

Innovation Solution

A highly sensitive method involving allergen digestion, fragmentation, and mass spectrometry to identify peanut allergen digest products, allowing for the determination of allergen signatures and release profiles using techniques like LC-MS-MS and nanoLC-MS-MS, with the use of internal standards and signature standards for comparison.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional detection methods are used, then the measurement process is simple, but the sensitivity and accuracy are insufficient to detect low concentrations of peanut allergens

Engineering Contradiction:

Improvesensitivity and accuracy of allergen detectionVSAvoidcomplexity of detection method

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The detection method is segmented into multiple stages: (1) digestion of peanut allergens into smaller peptides, (2) separation of digest products, and (3) detection by mass spectrometry. This segmentation allows the complex detection task to be broken down into manageable steps, each optimized for specific purposes, thereby achieving high sensitivity and accuracy while managing overall system complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Preliminary digestion and separation steps are performed before mass spectrometry detection to concentrate and prepare the allergen peptides. This preliminary action enhances the sensitivity of the final detection step by pre-concentrating the target analytes and removing interfering substances, allowing detection of very low allergen concentrations.

Inventive Principle:

Principle #10Preliminary action

2Measurement precision

If mass spectrometry methods are used to detect low concentration allergens, then measurement precision is improved, but the difficulty of detection and measurement increases

Engineering Contradiction:

Improvedetection precision of low concentration allergensVSAvoiddifficulty of allergen signature determination

Core Design Contradiction:

Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

Digestion enzymes and separation media act as intermediaries between the complex peanut allergen mixture and the mass spectrometry detector. These intermediaries simplify the sample matrix, concentrate target peptides, and remove interfering substances, thereby reducing the difficulty of detection while maintaining high measurement precision for low concentration allergens.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The mechanical and chemical complexity of direct allergen detection is replaced by substituting with a standardized mass spectrometry-based analytical system. This substitution transforms the detection difficulty into a routine analytical procedure with well-established protocols, reducing operational difficulty while achieving high precision.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If detailed allergen profiling is performed, then batch-to-batch consistency is ensured, but the time and resources required increase

Engineering Contradiction:

Improvebatch-to-batch consistency of therapeutic compositionsVSAvoidtime required for allergen characterization

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The method monitors changes in specific parameters (peptide mass spectra, relative abundances of characteristic peptides) that serve as fingerprints for allergen composition. By focusing on these key parameters rather than complete characterization, the method ensures batch-to-batch consistency while reducing the time and resources required compared to comprehensive allergen profiling.

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

Provides qualitative and quantitative information on peanut allergens, ensuring batch-to-batch consistency and accurate prediction of in vivo release profiles, even at very low concentrations.

Implementation Method 1

The methods include the step of digesting peanut allergens present in a composition (e.g., medium or other sample) from the composition to generate allergen digest products

Methodology Applied

Scientific EffectEnzymatic hydrolysis: Hydrolysis

Implementation Method 2

detecting and identifying the allergen digest products by mass spectrometry

Methodology Applied

Scientific EffectMass spectrometry:

Data Source

PatentUS20260036591A1Methods for characterizing compositions comprising peanut antigens

Publication Date: 2026.02.05 SANOFI SA(FR)

AI summary

Methods for determining an in vitro release profile of peanut allergens in a sample are provided. Methods for determining one or more signatures of peanut allergens in a sample are provided.