Polyamide Depth Filter for Biopolymer Aggregate Removal

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Solution Overview

Problem

Current methods for removing biopolymer aggregates and viruses from fluids, such as protein solutions, face challenges including blockage of filtration membranes, sensitivity to pH and conductivity, and the need for complex charged or surface-modified membranes, which are costly and can release particles into the filtrate.

Innovation Solution

A method involving filtration through a porous polyamide-comprising shaped body to selectively remove biopolymer aggregates, followed by filtration through a virus-retentive membrane with a molecular weight cut-off of 100 to 1000 kD, achieving significant virus depletion without membrane blockage and particle release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If size-exclusion filtration is used to remove biopolymer aggregates, then aggregate removal is achieved, but the filtration membrane becomes blocked

Engineering Contradiction:
Improveaggregate removal efficiencyVSAvoidfiltration flow capacity
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The invention divides the filtration process into two sequential stages: first using a depth filter to remove aggregates, then using a virus filter for virus removal. This segmentation prevents aggregates from blocking the virus filter pores, maintaining both aggregate removal efficiency and virus filter productivity throughout the process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The depth filter performs preliminary removal of biopolymer aggregates before the fluid reaches the virus filter. This preliminary action prevents aggregates from accumulating and blocking the virus filter pores, ensuring sustained filtration capacity and eliminating the need for frequent filter replacement.

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If charged or surface-modified membranes are used to remove aggregates, then selective affinity binding is improved, but the membranes become sensitive to pH and conductivity changes

Engineering Contradiction:
Improveselective aggregate removalVSAvoidpH and conductivity range
Core Design Contradiction:
Manufacturing precisionVSAdaptability or versatility

Solution Approach 1:

The depth filter uses a homogeneous porous structure without charged or surface-modified regions, creating uniform flow paths that are insensitive to pH and conductivity variations. This homogeneous design allows the system to maintain consistent aggregate removal performance across a wide range of solution conditions.

Inventive Principle:
Principle #33Homogeneity

Solution Approach 2:

The invention uses a disposable depth filter with a simple porous structure that does not require complex charged or surface-modified materials. This approach eliminates sensitivity to pH and conductivity while providing effective aggregate removal, making the system more versatile for different application conditions.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Productivity

If kieselguhr-containing depth filters are used for aggregate removal, then filtration capacity is increased, but particles are released into the filtrate

Engineering Contradiction:
Improvefiltration capacityVSAvoidparticle release into filtrate
Core Design Contradiction:
ProductivityVSLoss of substance

Solution Approach 1:

The invention uses a depth filter made from porous polyamide material with controlled pore structure that provides high filtration capacity through physical entanglement and size exclusion. The porous structure traps aggregates effectively while the polyamide material itself does not release particles into the filtrate, unlike kieselguhr-containing filters.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The filter combines porous polyamide material with a structure designed for high capacity aggregate retention. This composite approach achieves both high filtration capacity and low particle release by using a material composition that is both effective at trapping aggregates and inert to prevent leaching into the filtrate.

Inventive Principle:
Principle #40Composite materials

4Manufacturing precision

If parvovirus filters are used for virus removal, then virus depletion is achieved, but the filters are highly sensitive to blockage due to small size differences between proteins and viruses

Engineering Contradiction:
Improvevirus retention efficiencyVSAvoidfiltration capacity
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The filtration system is segmented into two specialized filters: a depth filter for aggregate removal and a virus filter for virus retention. By separating these functions, the virus filter operates on pre-cleaned fluid with minimal aggregate content, preventing blockage while maintaining high virus retention efficiency.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The depth filter performs preliminary removal of aggregates that would otherwise block the virus filter. This preliminary cleaning action protects the virus filter from blockage, allowing it to maintain high filtration capacity while achieving the required virus depletion through its specialized pore structure.

Inventive Principle:
Principle #10Preliminary action

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 method effectively reduces virus content by at least 99.9% while maintaining high filtration capacity across a wide pH range, avoiding the use of complex membranes and minimizing particle release, thus being more cost-effective and efficient than existing techniques.

Implementation Method 1

filtering the fluid containing the biopolymer aggregates and viruses through a porous, polyamide-comprising shaped body, the internal and external surfaces of which have the same chemical and physical properties as the shaped-body matrix which is enclosed by the surfaces, wherein the biopolymer aggregates are selectively depleted from the fluid by adsorption

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

filtering the fluid from step (a) through at least one membrane having a molecular weight cut-off of from 100 to 1000 kD, wherein the content of viruses in the fluid is reduced by at least 99.9% with respect to the content of viruses prior to carrying out step (a)

Methodology Applied
Scientific EffectSize-exclusion filtration: Filter (physical)

Data Source

PatentUS10987629B2Method for removing biopolymer aggregates and viruses from a fluid
Publication Date: 2021.04.27 SARTORIUS STEDIM BIOTECH GMBH
  • US10987629B2 patent drawing
  • US10987629B2 patent drawing
  • US10987629B2 patent drawing

AI summary

The present invention relates to a method for removing biopolymer aggregates and viruses from a fluid. In a first step, the biopolymer aggregates are selectively removed by filtration through a porous, polyamide-comprising shaped body having a native surface. In a second step, the biopolymer aggregate-free fluid is filtered through at least one suitable virus-retentive membrane.