Dual-Functional Antibody Purification Carrier
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Solution Overview
Problem
Current methods for purifying antibodies are inefficient in removing aggregates and impurities, requiring multiple chromatography steps and adjustments in pH and ionic strength, which complicates the process and reduces yield.
Innovation Solution
A novel method involving a carrier with both affinity ligands and cation exchange groups is used for simultaneous affinity chromatography and cation exchange chromatography, allowing for the purification of antibodies at acidic pH, thereby improving the separation of monomers and reducing the burden on subsequent impurity removal steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If multiple chromatography steps are used for antibody purification, then the purity of the final product is improved, but the process complexity and time consumption increase
Solution Approach 1:
The patent combines affinity chromatography and cation exchange chromatography into a single integrated chromatography step using a dual-functional carrier. The carrier contains both affinity ligands (such as protein A, G, or L) and cation exchange groups, allowing simultaneous capture of antibodies through affinity binding and separation from aggregates/impurities through cation exchange interactions, thereby reducing multiple steps into one while maintaining high purity
Solution Approach 2:
The patent develops a universal dual-functional carrier that can perform both affinity chromatography and cation exchange chromatography functions simultaneously. This multi-functional carrier eliminates the need for separate columns and multiple purification steps, simplifying the overall process while achieving the same or better purification results
2Manufacturing precision
If pH adjustments are made between chromatography steps, then the separation efficiency is improved, but the process time and operational complexity increase
Solution Approach 1:
The patent merges affinity chromatography and cation exchange chromatography into a single step that operates effectively at acidic pH (pH 3.0-5.0). The dual-functional carrier allows both affinity binding and cation exchange separation to occur simultaneously under the same pH conditions, eliminating the need for pH adjustments between steps while maintaining high separation efficiency for monomers from aggregates
3Manufacturing precision
If multiple chromatography steps are used for aggregate removal, then the aggregate removal efficiency is improved, but the productivity decreases
Solution Approach 1:
The patent combines aggregate removal and antibody purification into a single chromatography step using the dual-functional carrier. The cation exchange groups on the carrier interact with positively charged aggregates at acidic pH, while the affinity ligands specifically bind monomeric antibodies, achieving both aggregate removal and purification simultaneously, thereby doubling productivity compared to sequential steps
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 enhances the purity and selectivity of antibody purification, reducing the complexity and cost of the process by integrating two chromatography steps into one, improving the recovery and purity of monomeric antibodies.
Implementation Method 1
a carrier having an affinity ligand for specifically purifying the target molecule (for example, an antibody or a substance derived from an antibody)
Implementation Method 2
a carrier having a cation exchange group at the same time, and the purifications of the affinity chromatography and the cation exchange chromatography are performed at one chromatography step
Data Source
AI summary
The first embodiment of the present invention is a method for purifying an antibody or a substance derive from an antibody, wherein a carrier 1 having an affinity ligand with affinity for the antibody or the substance derived from the antibody and a carrier 2 having a cation exchange group are used to prepare an integrated column 1 connecting a column containing the carrier 1 and a column containing the carrier 2 or a column 2 having the mixture of the carrier 1 and carrier 2, the antibody or the substance derived from the antibody is applied to the column 1 or the column 2, and then the adsorbed antibody or substance derived from the antibody is eluted from the column 1 or the column 2. The second embodiment of the present invention is a method for using a carrier having a cation exchange group, wherein a solution containing an antibody or a substance derived from an antibody is applied to a carrier having a cation exchange group having a carboxyl group-containing ligand and pKa of 4.0 or more, and the antibody or the substance derived from the antibody is eluted by an acidic buffer having pH of 4.0 or less.