Anionic Grafted Nonwoven Filters for Low-Pressure MAb Purification
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Solution Overview
Problem
Current chromatographic methods for purifying biomolecules, such as monoclonal antibodies, face limitations in throughput and efficiency due to diffusion and binding issues, requiring high pressure drops and struggling with the removal of biocontaminants like host cell proteins and viruses, which leads to the need for improved filtration technologies.
Innovation Solution
A functionalized nonwoven substrate with average fiber sizes of 0.7 to 15 microns and a void volume of 50 to 95% is developed, featuring a polymer with anionic monomer units grafted onto its surface, allowing for effective separation and purification of biomolecules by ionizing radiation and subsequent graft-polymerization, enhancing affinity for biocontaminant removal and operating at lower pressure drops.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional column chromatography techniques are used for purification, then separation and purification of biomolecules can be achieved, but throughput is low and bottlenecking issues occur in downstream purification
Solution Approach 1:
The patent employs a nonwoven porous support material with controlled pore size and distribution, allowing biomolecules to access binding sites throughout the three-dimensional structure. This porous architecture enables simultaneous binding of multiple molecules, dramatically increasing throughput compared to conventional column chromatography while maintaining separation efficiency.
Solution Approach 2:
The invention transitions from traditional one-dimensional column flow to a three-dimensional nonwoven matrix structure. This dimensional change allows fluid to penetrate throughout the material volume, creating numerous parallel binding pathways that eliminate bottlenecking and significantly enhance productivity in downstream purification processes.
2Productivity
If larger column diameters are used to increase throughput, then more material can be processed, but packing difficulties and channeling problems increase
Solution Approach 1:
The nonwoven porous support material is provided as a pre-formed three-dimensional matrix that requires no packing operation. The material's inherent porosity and structural integrity allow it to be directly installed in large-diameter vessels, eliminating all packing-related difficulties including channeling, while maintaining uniform flow distribution throughout the entire cross-section.
3Reliability
If absorption operation is conducted until predetermined loading is reached, then product loss and contaminant breakthrough are prevented, but dynamic capacity is significantly less than overall capacity
Solution Approach 1:
The nonwoven porous support material is pre-functionalized with binding moieties throughout its three-dimensional structure before use. This preliminary action ensures that binding sites are uniformly distributed and accessible from the outset, allowing the material to operate at or near its overall capacity while maintaining reliable product recovery, as the entire matrix volume is actively engaged in binding from the beginning of the process.
4Quantity of substance
If Protein A resin is used for capture, then monoclonal antibodies can be bound, but trace impurities bind and require additional polishing steps
Solution Approach 1:
The patent applies specific functional groups or moieties to localized regions or specific fiber surfaces within the nonwoven matrix, creating zones with tailored binding characteristics. This local quality control allows selective binding of target antibodies while excluding certain impurities, reducing or eliminating the need for additional polishing steps and simplifying the overall process.
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 functionalized substrate significantly improves the separation and purification efficiency of biomolecules by enabling high-throughput filtration with reduced pressure drops, effectively removing biocontaminants and maintaining filterability even when triggered by contaminants, thus addressing the limitations of conventional chromatography.
Implementation Method 1
exposing the nonwoven substrate to ionizing radiation in an inert atmosphere, and subsequently imbibing the exposed substrate with a solution comprising grafting anionic monomers to graft polymerize said monomers to the surface of the nonwoven substrate
Implementation Method 2
graft polymerize said monomers to the surface of the nonwoven substrate
Implementation Method 3
The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples
Implementation Method 4
chromatographic separation and purification operations can be performed on biological product mixtures, based on the interchange of a solute between a moving phase, which can be a gas or liquid, and a stationary phase
Data Source
AI summary
A grafted nonwoven substrate is disclosed having average fiber sizes of 0.7 to 15 microns, and a void volume of 50 to 95%, and a polymer comprising anionic monomer units grafted to the surface of the nonwoven substrate. The article may be used as a filter element to purify or separate target materials, such as monoclonal antibodies (MAb), from a fluid mixture.