Nucleic Acid Labeling for mRNA Vaccine Composition Evaluation
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Solution Overview
Problem
Current methods for evaluating the deterioration of mRNA vaccines, such as fluorescence fingerprint technology, face challenges in detecting the state of degradation due to the need for specific labeling substances and the complexity of distinguishing between multiple fluorescent dyes, especially when dealing with mixed analytes and structural changes.
Innovation Solution
A composition evaluation method using a labeling substance with a nucleic acid structure that nonspecifically interacts with multiple types of objects, allowing for the acquisition of a fluorescence fingerprint to assess the state of the composition without separating the objects, and employing machine learning to create a state estimation model for accurate evaluation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If specific labeling substances are used for each object type in fluorescence fingerprint technology, then the detection specificity is improved, but the device complexity and preparation cost increase significantly
Solution Approach 1:
The patent applies universality by using a single type of labeling substance (nucleic acid-based fluorescent label) that can interact with multiple different object types (intact mRNA, degraded mRNA, lipids, proteins) through common nucleic acid interactions. This eliminates the need to prepare different specific labeling substances for each target, reducing preparation complexity while maintaining detection capability across multiple analytes
Solution Approach 2:
The patent changes the detection parameter from requiring specific molecular recognition (specific labeling) to detecting general nucleic acid interactions through fluorescence intensity patterns. By analyzing the overall fluorescence fingerprint pattern rather than specific individual signals, the method achieves detection of multiple object types using a single labeling substance type
2Adaptability or versatility
If multiple fluorescent dyes are used to detect different components, then the detection coverage is improved, but the measurement precision deteriorates due to wavelength overlap
Solution Approach 1:
The patent merges the detection of multiple different object types (mRNA, degraded products, lipids, proteins) into a single unified fluorescence fingerprint measurement using one type of labeling substance. Instead of combining multiple fluorescent dyes with overlapping wavelengths, the method combines multiple detection targets into a single measurement approach, analyzing their collective interaction pattern with the nucleic acid-based label
Solution Approach 2:
The patent extracts the essential detection information by focusing on the fluorescence intensity pattern as a whole rather than trying to distinguish individual component signals. By taking out the specific wavelength differentiation requirement and relying on the overall fingerprint pattern analysis, the method avoids the signal overlap problem while maintaining comprehensive detection coverage
3Measurement precision
If RNA purification is performed before measurement, then the measurement accuracy is improved, but the reliability deteriorates due to degradation during handling
Solution Approach 1:
The patent applies preliminary action by performing the labeling step immediately upon sample acquisition, before any purification or handling that could cause degradation. The nucleic acid-based fluorescent label binds to the mRNA and degraded products in situ, capturing the deterioration state at the moment of sampling without requiring subsequent purification steps that expose the sample to degradation risks
Solution Approach 2:
The method enables self-service detection where the labeling substance directly interacts with the sample components (intact and degraded mRNA, lipids, proteins) in their native state within the formulation. The system does not require external purification or complex sample preparation, allowing the sample to be evaluated in situ, thereby maintaining sample stability and reliability
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 simple and accurate evaluation of the state of compositions containing multiple objects, reducing the need for multiple labeling substances and allowing detection of unexpected structural changes, thereby facilitating the assessment of mRNA vaccine deterioration.
Implementation Method 1
a labeling substance having an interaction portion and a fluorescence-emitting portion
Data Source
AI summary
An object of the present invention is to provide a composition evaluation method capable of grasping the state of a composition by a simple method without separating an object. A composition evaluation method that solves the above object includes the steps of: mixing a composition containing one or more types of objects and a labeling substance having an interaction portion and a fluorescence-emitting portion to prepare a mixture; acquiring a fluorescence fingerprint for the mixture; and evaluating a state of the composition based on the fluorescence fingerprint, wherein the interaction portion has a nucleic acid structure capable of interacting with each of a plurality of types of the objects and/or a nucleic acid structure capable of interacting with a plurality of positions of each of one or more types of the objects.