Filtration Membrane Cross-Section Staining for Protein Aggregate Clogging

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Existing methods fail to determine the cause of membrane clogging during filtration of protein-containing solutions, which can be due to protein aggregates, leading to potential side effects and regulatory challenges.

Innovation Solution

A method involving passing a protein-containing solution through a filtration membrane, obtaining a cross-section, and treating it with a stain specific to protein aggregates to confirm their presence, allowing identification of aggregate-induced clogging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional evaluation methods (BCA, Bradford, Lowry) are used to determine protein concentration, then the evaluation can be performed with standard reagents, but the methods require multiple steps including reagent addition, incubation, and colorimetric measurement which increases evaluation time and complexity

Engineering Contradiction:
Improveprotein concentration measurement accuracyVSAvoidevaluation time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces conventional colorimetric measurement methods with surface plasmon resonance (SPR) technology. Instead of using chemical reagents and visual/color-based detection, the system uses optical resonance principles to directly detect protein concentration changes, eliminating the need for multiple incubation steps and manual measurement operations.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent extracts and isolates the essential measurement function from the complex conventional workflow. By using SPR technology, the system directly measures protein concentration without requiring the intermediate steps of reagent addition, incubation, and color development, thereby reducing evaluation time while maintaining accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

2Measurement precision

If conventional evaluation methods are used, then standard reagents can be utilized, but the methods involve multiple operational steps including reagent addition, mixing, and incubation which increases device complexity and operational difficulty

Engineering Contradiction:
Improveprotein concentration measurement accuracyVSAvoidevaluation operation simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent replaces manual mechanical operations (reagent addition, mixing, incubation) with an automated optical measurement system. The SPR instrument automatically detects protein concentration changes through optical resonance, eliminating the need for manual intervention in multiple steps and simplifying the overall operation.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system performs self-measurement through automated optical detection. The SPR instrument automatically detects protein concentration without requiring manual reagent addition or incubation steps, making the evaluation process simpler and more user-friendly while maintaining measurement precision.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If conventional colorimetric methods are used, then standard laboratory equipment can be utilized, but the methods require multiple incubation steps and reagent handling which increases the risk of contamination and measurement errors

Engineering Contradiction:
Improveprotein concentration measurement accuracyVSAvoidmeasurement reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent replaces contamination-prone manual reagent handling with an automated optical measurement system. The SPR technology detects protein concentration through optical resonance without requiring open reagent handling or multiple incubation steps, thereby reducing contamination risk and measurement errors.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent extracts the measurement function from the complex multi-step workflow that introduces errors. By using direct optical detection, the system eliminates the need for reagent addition and incubation steps where contamination and errors can occur, improving measurement reliability.

Inventive Principle:
Principle #2Taking out (Extraction)

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 determination of whether membrane clogging is caused by aggregates, facilitating targeted preventive measures to overcome clogging effectively.

Implementation Method 1

a refractometer to measure a refractive index of the solution

Methodology Applied
Scientific EffectRefraction: Refraction

Data Source

PatentEP4173696B1Evaluation method for protein-containing solution
Publication Date: 2026.05.20 ASAHI KASEI LIFE SCIENCE CORPORATION
  • EP4173696B1 patent drawingFigure 1~4
  • EP4173696B1 patent drawingFigure 5~7
  • EP4173696B1 patent drawingFigure 8~10

AI summary

The purpose of the present invention is to provide a method for evaluating the clogging of a filtration membrane with a protein-containing solution, including the steps of: a) passing a protein-containing solution through a filtration membrane, b) after the step a), obtaining a filtration membrane cross-section from the filtration membrane, c) treating the protein-containing solution before the step a), the filtration membrane before the step b), or the filtration membrane cross-section after the step b) with at least one stain specific to a protein aggregate, and d) confirming the presence of the protein aggregate in the filtration membrane cross-section.