Tissue Factor Stabilization via Surfactant-Nickel Complex

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Solution Overview

Problem

Natural and recombinant tissue factors used in clotting time measurements suffer from poor stability due to impurities and protein denaturation, leading to reduced biological activity over time, and existing stabilization methods can affect clotting time measurements or require costly purification processes.

Innovation Solution

The use of nonionic surfactants such as polyoxyethylene octyl phenyl ether and nickel ions in combination with tissue factors to form a complex, which stabilizes the tissue factor and maintains its biological activity during storage, either at room temperature or in frozen conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If natural tissue factor is extracted from animal brain, then the tissue factor can be obtained as a clotting reagent material, but it contains impurities such as blood components, lipoproteins and plasma proteins that cause poor stability and precipitate formation during long-term storage

Engineering Contradiction:
Improvetissue factor quantityVSAvoidstorage stability
Core Design Contradiction:
Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent extracts only the necessary tissue factor component from animal brain while removing impurities such as blood components, lipoproteins and plasma proteins through purification processes. This extraction approach obtains sufficient tissue factor quantity while eliminating the sources of instability that cause precipitate formation during storage.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a composite reagent system combining purified tissue factor with stabilizing agents and buffers. This composite formulation maintains tissue factor stability during long-term storage by integrating multiple components that work together to prevent degradation and precipitate formation, resolving the contradiction between obtaining sufficient tissue factor and maintaining storage stability.

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If stabilizers such as BSA are added to improve tissue factor stability, then storage stability is improved, but the stabilizer may affect clotting time measurements

Engineering Contradiction:
Improvestorage stabilityVSAvoidclotting time measurement accuracy
Core Design Contradiction:
Stability of the object's compositionVSMeasurement precision

Solution Approach 1:

The patent introduces inert buffers and stabilizing agents that act as intermediaries between the tissue factor and the measurement system. These intermediaries protect the tissue factor during storage without interfering with the clotting time measurement process, thereby maintaining both storage stability and measurement precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent optimizes the concentration and type of stabilizing agents to achieve the minimum effective amount that maintains storage stability without reaching thresholds that would interfere with clotting time measurements. By carefully controlling these parameters, both stability and measurement accuracy are preserved.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If partial purification is performed by antibody column chromatography or gel filtration chromatography, then stability is improved, but time and costs are required for preparing a large amount of tissue factor

Engineering Contradiction:
Improvestorage stabilityVSAvoidpreparation time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The patent performs preliminary purification steps during the tissue factor extraction process itself, removing major impurities before storage and use. This preliminary action reduces the need for time-consuming additional purification steps later, achieving both improved stability and reduced preparation time.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent extracts and removes impurities such as blood components, lipoproteins and plasma proteins during the initial preparation phase through efficient purification methods. This extraction approach achieves sufficient purification for stability improvement without requiring extensive additional purification steps that would consume excessive time and resources.

Inventive Principle:
Principle #2Taking out (Extraction)

4Quantity of substance

If genetic recombinant tissue factor is used, then purity is improved, but the solution may be liable to denature the protein and reduce biological activity depending on storage conditions

Engineering Contradiction:
Improvetissue factor purityVSAvoidbiological activity stability
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent formulates genetic recombinant tissue factor into a composite system containing stabilizing agents, buffers, and protective components. This composite formulation protects the pure recombinant protein from denaturation during storage, maintaining both the high purity achieved through recombinant production and the biological activity reliability needed for consistent measurement results.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent optimizes storage conditions and formulation parameters such as pH, ionic strength, and stabilizer concentration to prevent protein denaturation of genetic recombinant tissue factor. By carefully controlling these parameters, the patent maintains both the high purity of recombinant tissue factor and its biological activity stability across various storage conditions.

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 combination of nonionic surfactants and nickel ions effectively maintains the biological activity of tissue factors for a longer period, improving storage stability without affecting clotting time measurements, even in frozen storage, and enhancing the reagent's stability and usability for clinical applications.

Implementation Method 1

The use of nonionic surfactants such as polyoxyethylene octyl phenyl ether and nickel ions in combination with tissue factors to form a complex, which stabilizes the tissue factor

Methodology Applied
Scientific EffectComplex formation:

Implementation Method 2

nonionic surfactants such as polyoxyethylene octyl phenyl ether and nickel ions in combination with tissue factors to form a complex

Methodology Applied
Scientific EffectSurfactant stabilization: Surfactant

Implementation Method 3

The addition of a chelating agent such as EDTA to a solution containing a protein such as an enzyme is known to remove the influence of a heavy metal

Methodology Applied
Scientific EffectChelation:

Implementation Method 4

The peroxidation, oxidation and denaturation of a protein by the catalytic action of a heavy metal ion can be prevented by the chelating agent

Methodology Applied
Scientific EffectHeavy metal inhibition:

Data Source

PatentEP1975622B1Method for stabilizing tissue factor
Publication Date: 2011.06.01 SYSMEX CORP
  • EP1975622B1 patent drawingFigure 1
  • EP1975622B1 patent drawingFigure 2
  • EP1975622B1 patent drawingFigure 3

AI summary

The present invention provides a reagent for measuring clotting time comprising a nonionic surfactant, a nickel ion and a tissue factor. A method for stabilizing a tissue factor, and use of a nonionic surfactant and a nickel salt for stabilizing a tissue factor are also disclosed.