Glucose Polymer Purification via Activated Carbon and TLR Assays

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Solution Overview

Problem

Current methods for producing glucose polymers used in peritoneal dialysis are inadequate in ensuring complete removal of microbial contaminants and pro-inflammatory substances, leading to risks of peritonitis and inflammatory reactions in patients.

Innovation Solution

A process involving multiple purification steps including activated carbon treatment, filtration, and heat treatment, combined with in vitro inflammatory response tests using cell lines expressing Toll-Like Receptors (TLR) and NOD receptors to detect and quantify pro-inflammatory molecules, ensuring the effectiveness of decontamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional purification methods are used for glucose polymers, then production cost and process simplicity are maintained, but microbial contaminants and pro-inflammatory substances are not completely removed

Engineering Contradiction:
Improveremoval of microbial contaminantsVSAvoidpurification process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The purification process is divided into multiple sequential steps: activated carbon treatment to remove microbial contaminants, followed by filtration to remove particulates, and heat treatment to eliminate endotoxins. Each step targets specific contaminants, achieving comprehensive purification through segmented processing rather than a single complex method.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Activated carbon serves as an intermediary substance that adsorbs microbial contaminants and pro-inflammatory molecules from the glucose polymer solution. The carbon acts as a mediator between the contaminants and the purification system, enabling removal without direct contact with harsh chemicals or complex equipment.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If multiple purification steps are implemented, then removal of pro-inflammatory molecules is improved, but production time and process complexity increase

Engineering Contradiction:
Improveremoval of pro-inflammatory moleculesVSAvoidproduction time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

Activated carbon treatment is performed as a preliminary step before filtration and heat treatment. This preliminary action removes a significant portion of pro-inflammatory molecules early in the process, reducing the burden on subsequent steps and enabling faster overall processing while maintaining high removal efficiency.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The heat treatment step uses optimized temperature and time parameters to rapidly denature and remove endotoxins and other pro-inflammatory molecules. By adjusting thermal parameters to optimal values, the process achieves effective purification in a shortened time frame rather than requiring prolonged treatment.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If advanced detection methods using TLR cell lines are used, then detection precision of pro-inflammatory molecules is improved, but measurement complexity and cost increase

Engineering Contradiction:
Improvedetection of pro-inflammatory moleculesVSAvoiddetection system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The detection method extracts and measures specific pro-inflammatory molecules (endotoxins, PGNs, beta-glucans) from the complex glucose polymer matrix using TLR cell lines. The assay isolates the detection of these specific molecules from other components, achieving high precision by focusing measurement on target contaminants rather than analyzing the entire mixture.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

TLR cell lines serve as biological copies or models of the human immune system's pattern recognition receptors. These cell lines replicate the function of human TLRs in a controlled in vitro system, enabling precise detection of pro-inflammatory molecules without requiring complex human tissue samples or sophisticated imaging equipment.

Inventive Principle:
Principle #26Copying

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 process effectively reduces pro-inflammatory molecules to safe levels, enhancing the safety and quality of glucose polymers for therapeutic applications by identifying and removing contaminants, thereby minimizing the risk of inflammatory episodes.

Implementation Method 1

The process involves multiple purification steps including activated carbon treatment

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

The process involves multiple purification steps including activated carbon treatment, filtration, and heat treatment

Methodology Applied
Scientific EffectHeat treatment: Heat Treatment

Data Source

PatentEP2856154B1Methods for decontaminating circuits for producing glucose polymers and hydrolysates of glucose polymers
Publication Date: 2018.03.14 ROQUETTE FRERES SA
  • EP2856154B1 patent drawingFigure 1~3
  • EP2856154B1 patent drawingFigure 4~5
  • EP2856154B1 patent drawingFigure 6

AI summary

The present invention concerns a method for determining the impact of a production step or a purification step on the presence or nature of pro-inflammatory contaminating molecules in glucose polymers or the hydrolysates of same by using an in vitro test of inflammatory response using cell lines. It further concerns an optimised method of producing or purifying glucose polymers or the hydrolysates of same comprising an analysis of the pro-inflammatory contaminating molecules in glucose polymers or the hydrolysates of same and the selection of production or purification steps optimised with respect to the presence and nature of the pro-inflammatory contaminating molecules.