Split Intein Affinity Resin for Rapid Tagless Protein Purification

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Solution Overview

Problem

Current protein purification methods using affinity tags face challenges such as inefficient cleavage kinetics, premature cleavage, and ligand leakage during resin reuse, which affect the yield and purity of target proteins, especially in large-scale processes and repeated usage of chromatography resins.

Innovation Solution

Development of an affinity chromatography resin with immobilized N-terminal split intein fragments, which allows for higher ligand densities and multiple reuses even after harsh cleaning procedures, using specific sequences and methods for expression, solubilization, refolding, and covalent attachment to agarose beads, enabling efficient and stable protein purification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If intein-based affinity tag systems are used for purification, then tag removal can be achieved without chemical agents or proteases, but cleavage kinetics are slow requiring 16 hours or more of incubation

Engineering Contradiction:
Improvetag removal processVSAvoidcleavage speed
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The intein is divided into two separate fragments: an N-terminal fragment immobilized on the resin and a C-terminal fragment fused to the target protein. This segmentation enables the cleavage reaction to occur on the resin surface, dramatically improving cleavage kinetics from 16+ hours to minutes or hours, while still achieving complete tag removal without chemical agents or proteases

Inventive Principle:
Principle #1Segmentation

2Productivity

If affinity tag systems are used for protein purification, then rapid purification can be achieved, but additional steps are required to remove the affinity tag

Engineering Contradiction:
Improvepurification speedVSAvoidpurification steps
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system merges affinity purification and tag removal into a single integrated process. The N-terminal intein fragment on the resin provides affinity binding, while the same resin facilitates self-cleavage of the C-terminal intein fragment from the target protein. This eliminates the need for separate purification and tag removal steps, reducing overall process complexity

Inventive Principle:
Principle #5Merging (Combining)

3Duration of action of stationary object

If resin is reused after harsh cleaning procedures, then resin durability is improved, but ligand leakage occurs affecting purification quality

Engineering Contradiction:
Improveresin reuse capabilityVSAvoidbinding activity stability
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The N-terminal intein fragment is covalently immobilized on the resin surface before use, creating a stable anchor that prevents ligand leakage during harsh cleaning procedures. This preliminary covalent attachment ensures the ligand remains firmly bound to the resin even after repeated exposure to strong cleaning agents, maintaining binding activity and purification quality across multiple reuse cycles

Inventive Principle:
Principle #10Preliminary action

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 resin supports efficient and predictable purification of tag-less target proteins with improved yield and resin durability, reducing the need for additional steps and chemical agents, and maintaining binding activity and self-cleavage functionality for repeated use.

Implementation Method 1

immobilizing said protein as ligands on a chromatography resin

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Implementation Method 2

solubilizing said inclusion bodies and releasing expressed protein

Methodology Applied
Scientific EffectSolubilization: Solvation

Implementation Method 3

refolding said protein

Methodology Applied
Scientific EffectProtein refolding:

Implementation Method 4

purification of tag-less target proteins

Methodology Applied
Scientific EffectAffinity chromatography: Chromatography

Data Source

PatentEP3541508B1Production method for affinity chromatography resin
Publication Date: 2023.07.12 CYTIVA BIOPROCESS R&D AB
  • EP3541508B1 patent drawingFigure 1
  • EP3541508B1 patent drawingFigure 2
  • EP3541508B1 patent drawingFigure 3

AI summary

The present invention relates to the field of chromatography and more specifically to producing protein affinity chromatography resins comprising affinity ligands based on a N-terminal fragment of a split intein, such as DnaE from Nostoc punctiforme, as well as methods for using the same. The N-terminal fragments are produced in inclusion bodies in bacterial cells.