Prefiltration with Hydrophobic Resin for Virus Removal Membrane Clogging
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Solution Overview
Problem
Current methods for filtering high-concentration protein solutions are inefficient due to clogging issues with virus removal membranes, especially at concentrations above 20 mg/mL, and fail to effectively remove multimers and viruses in the final purification step of pharmaceutical manufacturing, leading to contamination risks.
Innovation Solution
A method involving a prefiltration step with a hydrophobic resin filter having a pore size of 0.08 µm to 0.25 µm, followed by a virus removal step using a synthetic polymer membrane, to filter protein-containing liquids with high protein concentrations and remove multimers and viruses, ensuring high efficiency and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a virus removal membrane is used to filter high-concentration protein solutions, then virus removal capability is improved, but membrane clogging occurs and filtration efficiency deteriorates
Solution Approach 1:
The filtration process is divided into two distinct stages: a prefiltration stage using a hydrophobic resin filter to remove multimers and particulate matter, followed by a virus removal stage using a synthetic polymer membrane. This segmentation prevents the virus removal membrane from clogging while maintaining its virus removal capability.
Solution Approach 2:
The prefiltration step is performed before the virus removal step to remove multimers and particulate substances that would otherwise cause clogging. This preliminary action protects the virus removal membrane and ensures sustained filtration efficiency throughout the process.
2Reliability
If a hydrophobic resin filter is used for prefiltration, then multimer removal capability is improved, but protein adsorption increases
Solution Approach 1:
The hydrophobic resin filter is designed with specific pore sizes (0.08 µm to 0.25 µm) that provide localized removal capability for multimers and particulate matter while allowing monomeric proteins to pass through. The pore size distribution creates different filtration zones that selectively remove impurities without adsorbing valuable proteins.
3Reliability
If the pore size of the prefilter is reduced to improve multimer removal, then removal efficiency is improved, but filtration resistance increases and protein flow decreases
Solution Approach 1:
The prefilter is designed with an optimized pore size range (0.08 µm to 0.25 µm) that balances multimer removal efficiency with protein flow rate. This parameter optimization ensures effective multimer removal while maintaining adequate filtration throughput for high-concentration protein solutions.
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
This approach allows for efficient filtration of high-concentration protein solutions, effectively removing multimers and viruses, thereby enhancing the safety and efficiency of pharmaceutical manufacturing by preventing contamination and maintaining membrane integrity.
Implementation Method 1
a prefiltration step of filtering the protein-containing liquid by a prefilter having a pore size of 0.08 μm to 0.25 μm and comprising a hydrophobic resin
Implementation Method 2
filtering the protein-containing liquid by a prefilter having a pore size of 0.08 μm to 0.25 μm
Implementation Method 3
a virus removal step of filtering the prefiltered liquid by a virus removal membrane
Data Source
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AI summary
A method for filtering a protein-containing liquid containing protein at a concentration of 20 mg/mL or more and 100 mg/mL or less, the method including a prefiltration step of filtering the protein-containing liquid by a prefilter having a pore size of 0.08 µm to 0.25 µm and including a hydrophobic resin, and a virus removal step of filtering the protein-containing liquid by a virus removal membrane including a synthetic polymer, after the prefiltration step, wherein the protein-containing liquid before conducting the prefiltration step includes 0.25 g or more of a trimer or higher multimer of the proteins having an average diameter of less than 100 nm, per 1 m2 of the virus removal membrane.