Leucine-Rich α2 Glycoprotein Composition for Alkaline pH Stability

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Solution Overview

Problem

Leucine-rich α2 glycoprotein (LRG) stability is compromised at pH levels below 7, leading to decomposition and loss over time, necessitating a solution for improved preservation.

Innovation Solution

A composition with a pH range of 7.8 to 9.0 and salt concentration of 300 mM to 600 mM, preferably using sodium salts, enhances LRG stability, allowing for accurate quantitative measurement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If LRG is stored in a solution with pH less than 7, then the solution is stable and easy to prepare, but LRG is gradually decomposed and lost over time

Engineering Contradiction:
ImproveLRG stabilityVSAvoidLRG loss
Core Design Contradiction:
Stability of the object's compositionVSLoss of substance

Solution Approach 1:

The patent applies parameter changes by adjusting the pH of the storage solution from acidic (pH < 7) to alkaline (pH 7.8-9.0). This fundamental parameter change transforms the storage conditions to prevent LRG decomposition while maintaining solution stability. The specific pH range of 7.8-9.0 was determined to be optimal for preserving LRG integrity over extended storage periods.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If the pH is adjusted to maintain LRG stability, then LRG decomposition is prevented, but the composition becomes more complex

Engineering Contradiction:
ImproveLRG stabilityVSAvoidcomposition complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

Rather than adding complex stabilizing agents or multiple components, the invention simplifies the approach by changing the fundamental pH parameter to the alkaline range (7.8-9.0). This single parameter adjustment maintains LRG stability without requiring complex formulation strategies, buffer systems, or additional stabilizing compounds.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If salt concentration is increased to 300-600 mM, then LRG stability is improved, but the solution becomes more concentrated and complex

Engineering Contradiction:
ImproveLRG stabilityVSAvoidsalt concentration
Core Design Contradiction:
Stability of the object's compositionVSQuantity of substance

Solution Approach 1:

The invention changes the salt concentration parameter to a specific high range (300-600 mM), which creates a physiological or near-physiological environment that stabilizes LRG. This parameter adjustment provides stability enhancement without requiring organic solvents, complex buffer systems, or multiple additives.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3865503B1Leucine rich alpha-2 glycoprotein composition
Publication Date: 2026.01.28 SEKISUI MEDICAL CO LTD
  • EP3865503B1 patent drawingFigure 1~2
  • EP3865503B1 patent drawingFigure 3

AI summary

An object is to provide a leucine-rich α2 glycoprotein composition comprising leucine-rich α2 glycoprotein and having excellent preservation stability. The object can be achieved by a leucine-rich α2 glycoprotein composition comprising leucine-rich α2 glycoprotein and having a pH of 7. 0 to 9.3.