Mutant Protein L Antibody Purification Mild Acid Dissociation

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Solution Overview

Problem

Conventional affinity supports have insufficient purification efficiency for antibodies under mild acidic conditions, and there is a need for an immunoglobulin binding protein with enhanced antibody dissociation rates under these conditions.

Innovation Solution

A mutant immunoglobulin binding protein derived from protein L, with specific amino acid sequence mutations, is used as an affinity ligand, providing high binding activity and efficient antibody dissociation under mild acidic conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If conventional affinity supports are used for antibody purification, then the binding capacity is maintained, but the purification efficiency under mild acidic conditions is insufficient

Engineering Contradiction:
Improvepurification efficiencyVSAvoidantibody dissociation rate
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent applies parameter changes by modifying the amino acid sequence of protein L at specific positions (16, 18, 20, 26, 28, 30, 32, 34, 35, 38, 42, 54, 57, 70) to alter the dissociation behavior of antibodies under acidic conditions. These sequence modifications change the chemical properties of the binding interface, enabling enhanced dissociation rates at mild acidic pH while preserving binding capacity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention applies local quality by making site-specific mutations at particular amino acid positions within the protein L sequence rather than uniform modifications throughout the entire protein. This targeted approach allows optimization of dissociation behavior at the binding interface while maintaining the overall structural integrity and binding capacity of the protein.

Inventive Principle:
Principle #3Local quality

2Reliability

If strongly acidic conditions are used for elution, then the dissociation of antibody from ligand is improved, but the antibody may be damaged by denaturation

Engineering Contradiction:
Improveantibody dissociation rateVSAvoidantibody denaturation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The mutated protein L exhibits parameter changes in its dissociation behavior, achieving high dissociation rates at mild acidic conditions (pH 3.0-4.5) compared to conventional protein L that requires strongly acidic conditions. This shift in dissociation pH profile allows elution without exposing antibodies to denaturing strongly acidic environments.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention converts the normally harmful effect of acidic conditions into a beneficial feature by engineering the protein L mutant to have enhanced dissociation at mild acidic pH. What would normally be a compromise between dissociation efficiency and antibody stability becomes an advantage, where mild acidity simultaneously achieves both effective dissociation and antibody protection.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Object-affected harmful factors

If mild acidic conditions are used for elution, then the antibody damage is reduced, but the purification efficiency is lowered due to difficult dissociation

Engineering Contradiction:
Improveantibody denaturationVSAvoidpurification efficiency
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The amino acid sequence modifications in protein L mutant fundamentally change the pH-dependent dissociation profile, transforming mild acidic conditions from a state of poor dissociation into one of optimal dissociation. This parameter change enables simultaneous achievement of high purification efficiency and antibody protection under the same mild acidic conditions.

Inventive Principle:
Principle #35Parameter changes

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 mutant immunoglobulin binding protein exhibits enhanced antibody dissociation rates and binding activity, improving the efficiency of antibody purification under mild acidic conditions, reducing the risk of antibody denaturation.

Implementation Method 1

the mutant has immunoglobulin κ chain binding activity

Methodology Applied
Scientific EffectProtein-protein binding: Adsorption

Data Source

PatentUS11884705B2Immunoglobulin binding protein, and affinity support using same
Publication Date: 2024.01.30 MERCK PATENT GMBH

AI summary

Provided are a protein L-derived immunoglobulin binding protein having an increased antibody dissociation rate under acidic conditions, and an affinity support using the same. Disclosed are an immunoglobulin binding protein comprising at least one mutant of an immunoglobulin binding domain, and an affinity support comprising a solid-phase support having the immunoglobulin binding protein bound thereto. A mutant of the immunoglobulin binding domain consists of an amino acid sequence having an identity of at least 85% with the sequence set forth in any one of SEQ ID NO:1 to SEQ ID NO:9 and a predetermined mutation, and the mutant has immunoglobulin κ chain binding activity.