Allergen Extract Purification by pH Shift and Size-Based Removal
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Solution Overview
Problem
Existing methods for producing allergen extracts for immunotherapy are inadequate in ensuring the safe and effective removal of low molecular weight proteins and toxic components, posing risks of allergic reactions and anaphylaxis.
Innovation Solution
A process involving basification of native allergen extracts to remove molecules below 3.5 kDa, followed by adjusting pH to neutrality, and optionally polymerizing with an aldehyde to eliminate molecules below 100 kDa, resulting in a depigmented and purified allergen extract.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If native allergen extract is used for immunotherapy, then immunogenicity is maintained, but allergenicity and risk of anaphylaxis remain high
Solution Approach 1:
The patent applies extraction by removing low molecular weight proteins (below 3.5 kDa) and toxic components from the native allergen extract through basification and filtration. This separates the harmful low molecular weight components from the beneficial immunogenic allergens, reducing anaphylaxis risk while maintaining immunotherapy efficacy.
Solution Approach 2:
The patent changes the pH parameter by basifying the allergen extract to remove acidic low molecular weight proteins, then adjusts back to neutral pH. This parameter change selectively removes harmful components while preserving the immunogenicity of larger allergen proteins.
2Reliability
If low molecular weight components are removed from allergen extract, then safety is improved, but protein content decreases
Solution Approach 1:
By changing the pH to basic conditions, the patent selectively precipitates or removes only low molecular weight proteins below 3.5 kDa while preserving larger immunogenic allergen proteins. After removal, the pH is adjusted back to neutral, recovering the protein content while maintaining safety improvements.
3Reliability
If allergen extract is purified to remove toxic components, then safety is enhanced, but biological potency is reduced
Solution Approach 1:
The patent selectively extracts and removes only the harmful low molecular weight toxic components below 3.5 kDa through basification and filtration, while preserving the larger biologically active allergen proteins that provide immunogenicity and therapeutic benefit.
Solution Approach 2:
The patent applies different treatment qualities to different molecular size components: low molecular weight proteins below 3.5 kDa are removed for safety, while larger immunogenic allergens are preserved for therapeutic efficacy, achieving local quality differentiation in the purification process.
4Manufacturing precision
If base treatment is applied to remove pigments and low molecular weight proteins, then purity is improved, but manufacturing complexity increases
Solution Approach 1:
The patent uses a simple pH parameter change to basic conditions to simultaneously achieve multiple purification goals: removing pigments, low molecular weight proteins, and toxic components in a single treatment step, followed by pH adjustment to neutral, simplifying the overall manufacturing process.
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 process increases protein and major allergen content while reducing biological potency and allergenicity, enhancing safety and efficacy for immunotherapy.
Implementation Method 1
disrupting the electrostatic, hydrophobic or other physical forces under such conditions as to detach non-allergenic compounds from the allergenically active proteins
Implementation Method 2
disrupting the electrostatic, hydrophobic or other physical forces under such conditions as to detach non-allergenic compounds from the allergenically active proteins
Implementation Method 3
chemically modifying native allergen extracts with aldehyde, mainly formaldehyde and glutaraldehyde, to produce allergoids
Data Source
AI summary
The invention relates to processes for producing semi-purified and purified allergen extracts and pharmaceutical compositions and vaccines for use in the diagnosis and treatment of allergy. In one aspect of the invention, a process for producing a depigmented allergen extract is provided, the process comprising: a) basifying a native allergen extract; and b) removing molecules having a molecular size of less than 3.5 kDa; and c) adjusting the pH to neutrality; thereby to produce a depigmented allergen extract.