Affinity Chromatography Carrier with Carboxy Groups for Antibody Purification
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Solution Overview
Problem
Current affinity chromatography carriers, such as those with cation exchange and affinity ligands, face challenges in achieving high purification purity and antibody adsorption capacity, particularly in reducing non-specific adsorption and improving the removal of host cell proteins from antibody drugs.
Innovation Solution
An affinity chromatography carrier is developed with a substrate of crosslinked cellulose, agarose, or acrylate-based polymers, coated with hydrophilic polysaccharides like dextran, and incorporating a carboxy group with an ion exchange capacity of 15-60 mmol/L-gel, along with an antibody-binding protein like protein A, to enhance antibody adsorption and purification purity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a cation exchange chromatography carrier with affinity ligands is used, then antibody adsorption capacity is improved, but purification purity deteriorates due to non-specific adsorption
Solution Approach 1:
The patent applies local quality by creating distinct functional zones on the carrier surface: hydrophilic polymer regions that reduce non-specific adsorption and cation exchange groups that provide selective binding. The hydrophilic polymer is grafted specifically at the surface region to minimize non-specific interactions, while cation exchange groups are distributed to provide selective antibody binding, thereby resolving the contradiction between adsorption capacity and purification purity.
Solution Approach 2:
The patent employs composite materials by combining hydrophilic polymers (such as polyethylene glycol or polyvinyl alcohol) with cation exchange functional groups on the carrier surface. This composite structure integrates the non-specific adsorption-reducing properties of hydrophilic polymers with the selective binding capabilities of cation exchange groups, simultaneously achieving high antibody adsorption capacity and high purification purity.
2Manufacturing precision
If the ion exchange capacity is increased to improve purification purity, then non-specific adsorption is reduced, but antibody adsorption capacity deteriorates
Solution Approach 1:
The patent applies parameter changes by optimizing the ion exchange capacity within a specific range of 10-50 mmol/L-gel and controlling the hydrophilic polymer grafting density. By precisely adjusting these parameters, the patent achieves a balance where sufficient cation exchange capacity reduces non-specific adsorption while maintaining adequate antibody adsorption capacity through optimized functional group distribution and hydrophilic polymer content.
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 carrier effectively reduces non-specific adsorption, improves purification purity, and maintains high antibody adsorption capacity, leading to enhanced productivity and quality in antibody drug production by specifically binding antibodies while minimizing host cell protein contamination.
Implementation Method 1
a carboxy group is introduced into the affinity chromatography carrier, and the amount of the carboxy group introduced is 15 mmol/L-gel to 60 mmol/L-gel in terms of ion exchange capacity
Implementation Method 2
an affinity ligand is at least one selected from the group consisting of an antibody-binding protein and an antibody-binding polypeptide
Data Source
AI summary
Provided is an affinity chromatography carrier having an excellent purification purity, including a substrate, a hydrophilic polymer, and an affinity ligand, in which the substrate is constituted of at least one selected from the group consisting of a polysaccharide, an acrylate-based polymer, a methacrylate-based polymer and a styrene-based polymer, the hydrophilic polymer is at least one selected from the group consisting of hydrophilic polysaccharides, the affinity ligand is at least one selected from the group consisting of an antibody-binding protein and an antibody-binding polypeptide, a carboxy group is introduced into the affinity chromatography carrier, and the amount of the carboxy group introduced is 15 mmol/L-gel to 60 mmol/L-gel in terms of ion exchange capacity.