Polymer-Stabilized Dry Nucleic Acid Amplification Compositions

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Solution Overview

Problem

Existing dry compositions for nucleic acid amplification suffer from insufficient storage stability due to reagent aggregation, structural changes, and adsorption to container surfaces, even when dried using conventional methods.

Innovation Solution

Incorporating a polymer with constitutional units derived from specific monomers, such as 2-(meth)acryloyloxyethyl phosphorylcholine, into the dry composition to enhance storage stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If conventional drying methods (freeze-drying, air-drying, evaporation drying) are used to dry nucleic acid amplification reagents, then the immediate stability of the composition is improved, but the storage stability decreases due to aggregation, structural changes, and adsorption to container surfaces

Engineering Contradiction:

Improveimmediate stabilityVSAvoidstorage stability

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The patent introduces a polymer as an intermediary substance that mediates between the nucleic acid amplification reagents and the container surface. This polymer prevents direct contact between the reagents and container, thereby preventing adsorption and structural changes during storage, while also providing immediate stability through protective interactions.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the chemical and physical parameters of the composition by adding a polymer with specific properties (molecular weight, composition, concentration). This parameter change fundamentally alters the behavior of the reagents during storage, preventing aggregation and degradation while maintaining activity.

Inventive Principle:

Principle #35Parameter changes

2Duration of action of stationary object

If nucleic acid amplification reagents are stored for a long period after drying, then the composition can be used later, but the activity of the reagents decreases due to aggregation, structural changes, and adsorption to container surfaces

Engineering Contradiction:

Improvestorage durationVSAvoidreagent activity

Core Design Contradiction:

Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent applies beforehand cushioning by incorporating a polymer into the composition before drying and storage. This polymer creates a protective environment that cushions the reagents against harmful effects such as aggregation, structural changes, and adsorption to container surfaces during long-term storage, thereby maintaining reagent activity.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The polymer acts as an intermediary that protects the reagents during extended storage periods, preventing direct interaction with the container surface and reducing aggregation and structural changes that would otherwise occur over time.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentEP4621069A1Dry composition for nucleic acid amplification uses, and nucleic acid amplification method using same

Publication Date: 2025.09.24 NOF CORP

Figure 1

AI summary

The present invention provides a dry composition for nucleic acid amplification, containing a polymer containing a constitutional unit derived from a monomer represented by the following formula (1): (definitions of symbols in the formula are as described in the specification).