Allergen Extract Purification via Segmented Liquid Extraction
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Solution Overview
Problem
Current methods for producing allergen extracts for immunotherapy do not adequately remove contaminating low molecular weight proteins and toxic components, posing safety and efficacy concerns for allergy treatment.
Innovation Solution
A process involving liquid extraction, separation, low molecular fraction removal, and optional acidification and polymerization steps to produce a purified allergen extract with reduced IgE binding capacity while maintaining immunogenicity, specifically targeting allergens from sources like peanuts, pollen, and cat dander.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If current methods are used to produce allergen extracts, then production is simpler and faster, but contaminating low molecular weight proteins and toxic components are not adequately removed
Solution Approach 1:
The production process is divided into multiple sequential purification stages: liquid extraction to remove lipids, separation to isolate source material residue, low molecular fraction removal to eliminate small proteins and toxins, optional acidification to remove pigments, and polymerization to reduce allergenicity. Each stage targets specific contaminants, progressively purifying the extract while maintaining manageable process complexity through modular design.
Solution Approach 2:
The method systematically extracts and removes unwanted components at different stages: lipids are extracted in the liquid extraction step, low molecular weight proteins and toxic components are removed in the low molecular fraction removal step, and pigments are extracted during acidification. This staged extraction approach achieves high purification without requiring all steps to be simultaneously complex.
2Reliability
If allergen extracts are highly purified to remove contaminants, then safety and efficacy improve, but production time and processing steps increase
Solution Approach 1:
The liquid extraction step is performed first to remove lipids and other non-polar contaminants before subsequent purification steps. This preliminary removal of bulk contaminants reduces the burden on later stages, allowing faster processing while maintaining high final purity. The staged approach prevents contamination carryover that would require longer remediation steps.
Solution Approach 2:
The method employs parameter changes at each stage to optimize purification efficiency: temperature and solvent selection in liquid extraction, molecular weight cutoff in low molecular fraction removal, pH adjustment during acidification, and crosslinking conditions in polymerization. These parameter optimizations enable each step to work more efficiently, reducing overall production time while achieving high reliability.
3Object-affected harmful factors
If low molecular weight proteins are removed to reduce toxicity, then safety improves, but some allergenic components may be lost
Solution Approach 1:
The method replaces simple molecular weight-based filtration with a more sophisticated low molecular fraction removal step that uses selective binding agents or chromatographic methods. This substitution allows differentiation between harmful low molecular weight proteins and beneficial allergenic components based on their specific chemical properties rather than just size, removing toxins while preserving allergens.
Solution Approach 2:
The polymerization step uses crosslinking agents as intermediaries to modify allergen proteins. These agents selectively react with specific functional groups on allergen molecules, creating polymers that maintain immunogenicity while reducing allergenicity. The intermediary enables transformation of the allergen structure to achieve safety without complete removal of allergenic components.
4Object-affected harmful factors
If polymerization is performed to reduce allergenicity, then safety improves, but additional processing steps are required
Solution Approach 1:
The polymerization step is merged with the final concentration and formulation stages. The crosslinking reaction is performed in the same equipment used for final product preparation, and the polymerized product is directly formulated into the final extract without requiring separate handling steps. This merging reduces the effective number of processing steps while achieving reduced allergenicity.
Solution Approach 2:
The polymerization process uses carefully controlled parameter changes (crosslinking agent concentration, temperature, time, pH) to optimize the reaction efficiency. By tuning these parameters, the process achieves complete allergenicity reduction in a single step rather than requiring multiple sequential treatments, effectively reducing the processing complexity.
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 results in a highly purified allergen extract with reduced allergic side effects and retained immunogenicity, enhancing the safety and efficacy of allergen vaccines and immunotherapy treatments.
Implementation Method 1
contacting a source material comprising an allergen with a liquid extraction agent to produce a mixture containing lipids dissolved in liquid phase and a solid phase consisting of source material residue
Implementation Method 2
subjecting the mixture to a first separation step to isolate the source material residue
Implementation Method 3
contacting the source material residue with an allergen extract agent to produce a mixture of allergens dissolved in liquid phase, and a solid phase consisting of non-allergenic residue
Implementation Method 4
subjecting the mixture to a second separation step to isolate the allergens dissolved in liquid phase
Implementation Method 5
subjecting the crude allergen extract to a low molecular fraction removal step to remove molecules having a molecular size of less than 3.5 kDa
Implementation Method 6
acidifying the native allergen extract, removing molecules having a molecular size of less than 3.5 kDa, and neutralising the pH to produce a depigmented allergen extract
Implementation Method 7
The process may further comprise a polymerisation step, comprising h) contacting a native allergen extract or a depigmented allergen extract with an aldehyde
Data Source
AI summary
The present invention discloses processes for producing native, depigmented and polymerised allergen extracts. The invention further discloses extracts produced via the processes, and pharmaceutical and vaccine compositions comprising the extracts, for diagnosis and treatment of allergy.