Polymer-Coated Filter for Protein Separation

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Solution Overview

Problem

Current membrane-based technologies for the separation and purification of monomeric proteins, particularly monomeric monoclonal antibodies, suffer from low biomaterial binding capacities, limiting their use in large-scale purifications and requiring complex processes.

Innovation Solution

A process utilizing a filter element with a porous substrate coated with a polymer that includes a hydrocarbon backbone and pendant groups with acidic groups linked by a spacer group of at least 6 catenated atoms, effectively separating aggregated proteins from monomeric proteins by binding the former while allowing the latter to pass through.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If membrane-based technologies are used for separation and purification of monomeric proteins, then the process is simplified and becomes more cost-effective, but the biomaterial binding capacity is low which limits use in large-scale purifications

Engineering Contradiction:

Improveprocess simplicity and cost-effectivenessVSAvoidbiomaterial binding capacity

Core Design Contradiction:

Ease of manufactureVSQuantity of substance

Solution Approach 1:

The patent merges the advantages of membrane-based technologies (process simplicity, cost-effectiveness) with the high binding capacity of functionalized materials by coating the membrane with polymers containing acidic groups and extended spacer groups, creating a hybrid system that achieves both ease of manufacture and high biomaterial binding capacity

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The invention uses composite materials consisting of a membrane substrate combined with polymer coatings that have extended spacer groups (at least 6 catenated atoms) linking acidic groups to the hydrocarbon backbone. This composite structure provides both the mechanical advantages of membranes and the high binding capacity of functionalized materials

Inventive Principle:

Principle #40Composite materials

2Device complexity

If functionalized membranes are used for separation, then the process is simplified compared to porous beaded chromatography resins, but the biomaterial binding capacity remains low

Engineering Contradiction:

Improveprocess complexityVSAvoidbiomaterial binding capacity

Core Design Contradiction:

Device complexityVSQuantity of substance

Solution Approach 1:

The patent changes the chemical parameters of the membrane surface by introducing polymers with extended spacer groups (at least 6 catenated atoms) that link acidic groups to the hydrocarbon backbone. This parameter change increases the biomaterial binding capacity while maintaining the simplicity of the membrane-based approach

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The extended spacer group acts as an intermediary between the hydrocarbon backbone and the acidic group, providing a longer chain (at least 6 catenated atoms) that enhances the binding capacity for biomaterials while maintaining the overall simplicity of the membrane structure

Inventive Principle:

Principle #24Intermediary (Mediator)

3Quantity of substance

If porous beaded chromatography resins are used for capture-and-elute purification, then high biomaterial binding capacity is achieved, but the process becomes more complex and requires elution steps and buffer exchanges

Engineering Contradiction:

Improvebiomaterial binding capacityVSAvoidprocess complexity

Core Design Contradiction:

Quantity of substanceVSDevice complexity

Solution Approach 1:

Instead of using a complex porous beaded resin system that requires capture and elution steps, the patent inverts the approach by using a membrane with extended spacer groups that enables direct separation with high binding capacity, eliminating the need for complex elution procedures and buffer exchanges

Inventive Principle:

Principle #13The other way round (Inversion)

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 enhances protein binding capacities and simplifies the purification process, enabling efficient recovery of monomeric proteins with high purity and reduced processing time, while avoiding the need for elution steps and buffer exchanges.

Implementation Method 1

a polymer that includes a hydrocarbon backbone and a plurality of pendant groups attached to the hydrocarbon backbone, wherein each of a first plurality of pendant groups includes: (1) at least one acidic group or salt thereof

Methodology Applied

Scientific EffectElectrostatic interaction: Electrostatics

Data Source

PatentEP3510041B1Processes for separating aggregated proteins from monomeric proteins in a biological solution

Publication Date: 2023.05.31 SOLVENTUM INTELLECTUAL PROPERTIES CO

AI summary

A process for separating aggregated proteins from monomeric proteins in a biological solution, the process including: providing at least one filter element having a contacting surface, wherein the filter element comprises filter media comprising: a porous substrate; and disposed on the porous substrate, a polymer comprising a hydrocarbon backbone and a plurality of pendant groups attached to the hydrocarbon backbone, wherein each of a first plurality of pendant groups comprises: (1) at least one acidic group or salt thereof; and (2) a spacer group that directly links the at least one acidic group or salt thereof to the hydrocarbon backbone by a chain of at least 6 catenated atoms; and allowing an initial biological solution to contact the contacting surface of the filter element under conditions effective to separate the aggregated proteins from the monomeric proteins such that a final biological solution includes purified monomeric proteins.