Recombinant FSH Purification via Chromatography Sequence
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for purifying recombinant follicle stimulating hormone (FSH) often rely on reverse phase chromatography and immunoaffinity chromatography, which are costly and inefficient, and there is a need for methods that avoid these steps while achieving high purity and specific activity.
Innovation Solution
A method involving anion exchange chromatography, hydrophobic interaction chromatography, and dye affinity chromatography, performed in various orders, without using weak anion exchange or reverse phase chromatography, to achieve high yield and purity of recombinant FSH, potentially incorporating additional steps like cation exchange or size exclusion chromatography and ultrafiltration/nanofiltration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If reverse phase chromatography is used for FSH purification, then high purity is achieved, but production cost increases and process efficiency decreases
Solution Approach 1:
The patent changes the chromatographic parameters by replacing reverse phase chromatography with hydrophobic interaction chromatography operating at different pH and ionic strength conditions, achieving comparable purity with improved process efficiency and reduced costs
Solution Approach 2:
The patent extracts and eliminates the problematic reverse phase chromatography step from the purification sequence, replacing it with alternative chromatographic methods that achieve the same purification goal without the associated cost and efficiency penalties
2Manufacturing precision
If immunoaffinity chromatography is used for FSH purification, then high specific activity is achieved, but production cost increases
Solution Approach 1:
The patent replaces expensive immunoaffinity chromatography media with more economical chromatographic media that can be used multiple times, achieving comparable specific activity at reduced production cost
Solution Approach 2:
The patent modifies the purification approach by using chromatographic conditions (pH, ionic strength, temperature) that optimize binding and elution of FSH without requiring expensive immunoaffinity reagents, thereby reducing production costs while maintaining specific activity
3Manufacturing precision
If multiple chromatography steps are used for FSH purification, then high purity is achieved, but process complexity increases
Solution Approach 1:
The patent combines multiple purification functions into a streamlined chromatographic sequence using three well-established chromatographic methods that work synergistically, reducing overall process complexity compared to using more specialized or numerous purification steps
Solution Approach 2:
The patent employs chromatographic media and conditions that serve multiple purification functions simultaneously, allowing a single chromatography step to achieve both purification and concentration, thereby reducing the total number of steps required
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 method results in high-purity recombinant FSH with a high specific activity, avoiding costly steps and ensuring efficient purification processes, suitable for fertility treatments with improved patient convenience and compliance.
Implementation Method 1
subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography
Implementation Method 2
to a hydrophobic interaction chromatography
Implementation Method 3
to a dye affinity chromatography
Data Source
AI summary
The present invention relates to a method for purifying a recombinant follicle stimulating hormone (FSH) or recombinant FSH variant. The method comprises the steps of subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography, to a hydrophobic interaction chromatography, and to a dye affinity chromatography, wherein these chromatographies may be performed in any order, and wherein the method neither comprises a weak anion exchange chromatography nor a reverse phase chromatography. The method of purification results in a high yield of recombinant FSH having a desired degree of purity. The obtained FSH is especially useful for the prophylaxis and treatment of disorders and medical indications where FSH preparations are considered as useful remedies.