Protein-Containing Solution Filtration for Aggregate Clogging Detection
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Solution Overview
Problem
Existing methods fail to accurately determine the cause of membrane clogging during filtration of protein-containing solutions, particularly due to protein aggregates, which can lead to incomplete purification and potential side effects in biopharmaceuticals.
Innovation Solution
A method involving passing a protein-containing solution through a filtration membrane, obtaining a cross-section of the membrane, and treating it with a stain specific to protein aggregates to confirm their presence, allowing identification of aggregate-induced clogging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If membrane separation is used to separate impurities by size, then purification efficiency is improved, but membrane clogging occurs reducing flux
Solution Approach 1:
The patent applies preliminary action by introducing an aggregate removing membrane upstream of the virus removing membrane to remove protein aggregates before they reach the virus removing membrane. This preventive measure stops aggregates from causing complete blocking in the virus removing membrane, thereby maintaining flux while preserving purification efficiency.
2Object-affected harmful factors
If protein aggregates are present in the solution, then complete blocking of the membrane occurs, but detecting and confirming aggregate presence is difficult
Solution Approach 1:
The patent employs color changes by using a fluorescence stain that binds to protein aggregates, causing them to emit fluorescence. This allows visual detection and confirmation of aggregate presence in the membrane cross-section, transforming the invisible aggregate blocking problem into a detectable fluorescence signal.
Solution Approach 2:
The patent uses a fluorescence stain as an intermediary substance that mediates between the aggregate and the detection system. The stain binds to aggregates and transfers their presence into a detectable fluorescence signal, enabling identification of aggregate-induced clogging without directly observing the aggregates themselves.
3Object-affected harmful factors
If aggregates are removed using an aggregate removing membrane, then complete blocking is prevented, but standard blocking and cake filtration may still occur
Solution Approach 1:
The patent applies feedback by using the fluorescence stain to detect aggregate presence in the membrane cross-section. This detection information provides feedback on whether aggregates are present and causing clogging, allowing operators to adjust filtration conditions or add aggregate removal steps as needed, thereby adapting to different clogging scenarios.
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 maintain membrane efficiency and ensure product safety.
Implementation Method 1
treating the filtration membrane cross-section after the step b) with at least one stain specific to an aggregate of the protein
Implementation Method 2
passing a protein-containing solution through a filtration membrane
Data Source
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, andd) confirming the presence of the protein aggregate in the filtration membrane cross-section.