FGF21 Protein Heat-Elasticity Purification Method

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Solution Overview

Problem

Current methods for producing and purifying FGF21 protein face challenges in maintaining its structural integrity and physiological activity at elevated temperatures, where most proteins denature and precipitate.

Innovation Solution

A method involving culturing a transformant to produce FGF21 and heating it to 40° C or higher, leveraging the protein's heat stability and heat-elasticity to prevent denaturation and precipitation, allowing for efficient production and purification by simplifying the protein production process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional protein production methods are used, then production process is simple, but FGF21 denatures and loses structural integrity at elevated temperatures

Engineering Contradiction:
Improvestructural integrity of FGF21VSAvoidproduction process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the temperature parameter from conventional low temperature to elevated temperature (40°C or higher) to exploit the heat-elasticity of FGF21. This parameter change allows the protein to maintain structural integrity while enabling simplified production processes through heat-induced purification.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the potential harm of heat (which typically causes protein denaturation) into a benefit by utilizing the unique heat-elasticity of FGF21. The protein's ability to undergo reversible structural changes at elevated temperatures is harnessed to achieve both structural stability and process simplification.

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

2Productivity

If FGF21 is heated to high temperature, then production efficiency is improved, but most proteins denature and precipitate

Engineering Contradiction:
Improveproduction efficiencyVSAvoidprotein stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent changes the temperature parameter to elevated levels (40°C or higher) and leverages the specific thermal response of FGF21. This parameter change enables improved production efficiency through heat-induced solubility changes while maintaining protein stability due to the protein's inherent heat-elasticity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent utilizes the self-service property of FGF21's heat-elasticity, where the protein automatically maintains its structural integrity and solubility at elevated temperatures without requiring external stabilizing agents or complex process controls. The protein's inherent property serves the dual purpose of stability and process simplification.

Inventive Principle:
Principle #25Self-service

3Ease of manufacture

If conventional purification methods are used, then purification process is thorough, but production cost is high and process is complex

Engineering Contradiction:
Improvepurification process simplicityVSAvoidprotein loss during purification
Core Design Contradiction:
Ease of manufactureVSLoss of substance

Solution Approach 1:

The patent extracts and utilizes the heat-elasticity property of FGF21 to simplify the purification process. By heating the protein solution, the method selectively enhances the solubility and stability of FGF21 while causing impurities to precipitate or aggregate, thereby extracting the target protein from the mixture with minimal loss.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the temperature parameter to enable a simplified purification process. Elevated temperature (40°C or higher) induces selective solubility changes that allow for easier separation of FGF21 from impurities, reducing the need for complex chromatographic steps and minimizing protein loss.

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 method ensures that FGF21 maintains its original structure and physiological activity even after heat treatment, enhancing production efficiency and reducing costs by utilizing its unique heat stability and elasticity.

Implementation Method 1

the FGF21 protein is not denatured even when a temperature higher than the general protein denaturation temperature is applied

Methodology Applied
Scientific EffectHeat-elasticity:

Implementation Method 2

it is confirmed that the FGF21 protein is not denatured even when a temperature higher than the general protein denaturation temperature is applied

Methodology Applied
Scientific EffectThermal stability:

Data Source

PatentUS20240271174A1FGF21 production method using thermoelasticity of FGF21
Publication Date: 2024.08.15 TODD PHARM CO LTD
  • US20240271174A1 patent drawing
  • US20240271174A1 patent drawing
  • US20240271174A1 patent drawing

AI summary

The present application relates to a method of producing or purifying an FGF21 protein by using the heat-elasticity of FGF21.The method of producing or purifying the FGF21 protein according to an embodiment of the present application utilizes the heat stability and heat-elasticity of the FGF21 protein that is not denatured or precipitated even upon heat treatment and returns to the original structure when re-cooled after heat treatment, resulting in advantages of improving efficiency by simplifying a protein production process.