Porous adsorbent material, separation column using same for purifying biopharmaceutical, and method of manufacturing biopharmaceutical

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Solution Overview

Problem

Existing protein adsorption materials face challenges in maintaining high separation selectivity and preventing clogging during biopharmaceutical manufacturing, as proteins not intended for adsorption can adhere to the material surface, reducing the adsorption capacity of target proteins.

Innovation Solution

A porous adsorption material with a controlled thickness of a nonionic polymer layer on its surface, specifically between 1.5 μm and 5 μm, inhibits non-target protein attachment while allowing target protein adsorption, thereby enhancing separation selectivity and preventing material clogging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a protein adsorption material is used to adsorb target proteins, then adsorption capacity is improved, but non-target proteins also adsorb on the material surface causing clogging and reducing separation selectivity

Engineering Contradiction:
Improveadsorption capacityVSAvoidclogging and reduced separation selectivity
Core Design Contradiction:
Quantity of substanceVSObject-generated harmful factors

Solution Approach 1:

The invention applies different properties to different regions of the adsorption material. The inner surface of the hollow fiber is provided with a hydrophilic polymer layer to prevent non-target protein adsorption, while the outer surface maintains adsorption capability for target proteins. This local differentiation allows the material to simultaneously achieve high adsorption capacity and prevent clogging.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

A hydrophilic polymer layer is introduced as an intermediary substance between the adsorption material surface and the proteins in the solution. This polymer layer selectively interacts with non-target proteins to prevent their adsorption on the material surface, while allowing target proteins to be adsorbed by the underlying adsorption material.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If the surface of the adsorption material is chemically modified to improve adsorption selectivity, then separation performance is improved, but the material complexity and manufacturing difficulty increase

Engineering Contradiction:
Improveseparation selectivityVSAvoidmaterial structure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The invention utilizes the porous structure of the hollow fiber adsorption material to its advantage. The hydrophilic polymer layer is formed on the inner surface of the porous hollow fiber, allowing the porous structure to be maintained while adding the selective prevention function. The polymer layer fills or lines the pores internally, providing separation selectivity without requiring complex external modifications.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The invention creates a composite structure by combining the hollow fiber adsorption material with a hydrophilic polymer layer. This composite material integrates the adsorption capability of the hollow fiber with the anti-fouling properties of the hydrophilic polymer, achieving both high separation selectivity and simplified manufacturing compared to fully chemically modified surfaces.

Inventive Principle:
Principle #40Composite materials

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 material effectively adsorbs and removes impurities from biopharmaceutical solutions with high separation selectivity, maintaining the adsorption performance and preventing clogging, thus improving the efficiency of biopharmaceutical purification processes.

Implementation Method 1

a porous adsorption material having a layer containing a nonionic polymer on at least one surface of the porous adsorption material

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS20240173692A1Porous adsorbent material, separation column using same for purifying biopharmaceutical, and method of manufacturing biopharmaceutical
Publication Date: 2024.05.30 TORAY INDUSTRIES INC

AI summary

A porous adsorption material is used to adsorb and remove an impurity from a solution containing a raw biopharmaceutical compound while suppressing clogging and is high in separation selectivity. The porous adsorption material used to adsorb and remove an impurity from a solution containing a raw biopharmaceutical compound includes a layer containing a nonionic polymer on at least one surface of the porous adsorption material.