Antithrombin Purification via Mixed Mode Chromatography

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Solution Overview

Problem

Current protein purification methods in the biopharmaceutical industry face challenges in achieving high purity and efficiency, particularly in industrial-scale production, due to the complexity of protein compositions and the need for costly ligands and extensive pretreatment processes, which can damage protein quality and require lengthy manipulation times.

Innovation Solution

A method involving the use of mixed mode chromatography carriers with ion exchange and hydrophobic interaction groups, such as Capto adhere or Capto MMC, for direct protein recovery and purification, utilizing buffers with amino acids to separate and elute proteins while maintaining desired sialic acid binding ratios and reducing impurities like neuraminidase and aggregates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If affinity chromatography using a ligand specific to the objective protein is used, then purification effectiveness is improved, but cost increases and stable supply becomes difficult

Engineering Contradiction:
Improvepurification effectivenessVSAvoidcost and supply stability
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The patent uses Protein A as a substitute ligand that binds to antibodies rather than using a ligand specific to each objective protein. This copying approach allows the same carrier system to be used for different antibody purification needs, reducing cost and improving supply stability while maintaining purification effectiveness

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent creates a universal purification system where Protein A-conjugated carriers can purify different antibody types through a single mechanism. This multi-functional approach eliminates the need for protein-specific ligands, achieving both cost reduction and consistent supply across different production scenarios

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

2Device complexity

If simple chromatography without affinity chromatography is used, then cost and complexity are reduced, but pretreatment time increases and protein quality may deteriorate

Engineering Contradiction:
Improvechromatography system complexityVSAvoidpretreatment time
Core Design Contradiction:
Device complexityVSLoss of time

Solution Approach 1:

The patent performs concentration and buffer exchange as preliminary actions before chromatography, ensuring the culture supernatant is properly prepared. This preliminary treatment prevents protein deterioration during the process while enabling direct loading onto the chromatography column, reducing overall pretreatment time

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent maintains continuous useful action by optimizing the workflow from concentration through buffer exchange to chromatography loading, minimizing idle time and ensuring protein quality is maintained throughout the process without unnecessary interruptions

Inventive Principle:
Principle #20Continuity of useful action

3Manufacturing precision

If multiple chromatography steps are combined to achieve high purity, then purification quality is improved, but processing time and complexity increase

Engineering Contradiction:
Improvepurification qualityVSAvoidprocessing efficiency
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent combines concentration, buffer exchange, and chromatography purification into an integrated workflow where pretreatment and purification are merged into a continuous process. This merging achieves high purification quality while minimizing total processing time by eliminating separate handling steps

Inventive Principle:
Principle #5Merging (Combining)

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 approach enables rapid and efficient purification of proteins like Antithrombin and Erythropoietin with high sialic acid binding ratios and low aggregate content, improving yield and quality, and reducing pretreatment time and potential protein damage.

Implementation Method 1

adsorbing the Antithrombin onto the anion exchange carrier

Methodology Applied
Scientific EffectIon exchange: Ion Exchange

Implementation Method 2

washing with a buffer containing glycine to wash and remove impurities

Methodology Applied
Scientific EffectChromatography: Chromatography

Implementation Method 3

eluting the Antithrombin adsorbed onto the anion exchange carrier by increasing the salt concentration or conductivity of the buffer, or by varying pH of the buffer

Methodology Applied
Scientific EffectIon exchange: Ion Exchange

Data Source

PatentEP2727930B1Method for purifying antithrombin
Publication Date: 2019.12.25 KYOWA HAKKO KIRIN CO LTD
  • EP2727930B1 patent drawingFigure 1
  • EP2727930B1 patent drawingFigure 2
  • EP2727930B1 patent drawingFigure 3~4

AI summary

The present invention relates to protein purification. More particularly, a method for directly recovering an objective protein from a protein composition and purifying a protein with a desired quality in a rapid and efficient manner is provided. Further, a rapid purification method capable of efficiently removing impurities included in the protein composition is provided. Therefore, compared to the conventional purification methods, quality and yield of the protein can be remarkably improved.