IgG Fc Binding Polypeptide Stability Optimization

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current IgG Fc affinity ligands, such as Protein A and its variants, face limitations in stoichiometry and stability under acidic and alkaline conditions, necessitating the development of improved polypeptides for efficient antibody and Fc fusion protein purification in chromatography processes.

Innovation Solution

A novel IgG Fc-binding polypeptide with a specific amino acid sequence, designed to form a single three-helical bundle domain, is developed, offering enhanced binding capacity and stability through strategic amino acid substitutions and spacer sequences, allowing for optimized binding and cleavage properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If Protein A or its variants are used as affinity ligands for IgG Fc purification, then binding capacity is achieved, but stability under acidic and alkaline conditions deteriorates

Engineering Contradiction:
Improvestability under acidic and alkaline conditionsVSAvoidbinding capacity
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The invention divides the Protein A structure into five separate IgG Fc-binding domains (A, B, C, D, E) that can be independently expressed and combined. This segmentation allows optimization of each domain for specific conditions (acid/alkaline stability) while maintaining overall binding capacity through modular assembly into multimers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention creates composite affinity ligands by combining multiple different Protein A domains (e.g., A2B2C2D2E2) into single multimeric structures. This composite approach enables the ligand to exhibit both high binding capacity (through multiple domains) and improved stability (through strategic domain selection and arrangement).

Inventive Principle:
Principle #40Composite materials

2Productivity

If multiple IgG Fc-binding domains are combined in a single ligand, then binding capacity increases, but structural complexity increases

Engineering Contradiction:
Improvebinding capacityVSAvoidstructural complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention creates universal building blocks (the five Protein A domains) that can be independently expressed, stored, and recombined in various ratios (e.g., A2B2C2D2E2) to create different ligand variants. This modular universality simplifies production while enabling flexible optimization of binding capacity and stability profiles.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The invention systematically varies the composition parameters of the multimers (different ratios and combinations of domains A-E) to optimize performance. For example, certain domain combinations are selected for acid stability while others optimize for alkaline stability, allowing parameter tuning without increasing fundamental structural complexity.

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 polypeptide achieves improved binding affinity and stability under various pH conditions, enabling efficient separation and purification of IgG Fc-containing molecules with high specificity and stability, suitable for industrial-scale chromatography applications.

Implementation Method 1

the native affinity of Protein A for the Fc portion of IgG

Methodology Applied
Scientific EffectAffinity binding: Adsorption

Implementation Method 2

The amino acid sequence DP is susceptible to acid catalyzed hydrolysis, so the DP sequence may be used as a cleavage site for separation of subunits in the multimer from each other

Methodology Applied
Scientific EffectAcid-catalyzed hydrolysis: Hydrolysis

Data Source

PatentEP2977088B1Immunoglobulin g fc region binding polypeptide
Publication Date: 2017.08.02 GE HEALTHCARE BIOPROCESS R&D
  • EP2977088B1 patent drawingFigure 1
  • EP2977088B1 patent drawingFigure 2
  • EP2977088B1 patent drawingFigure 3

AI summary

An immunoglobulin G Fc region binding polypeptide is provided, consisting of an amino acid sequence selected from i) and an amino acid sequence which has at least 95 % identity thereto. Also provided are methods for producing the polypeptide, compositions comprising the polypeptide, polynucleoties encoding the polypeptide, multimers of the polypeptide, and methods of using the polypeptide.