Allergenic Extract Purification via Cross-Flow Microfiltration
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Solution Overview
Problem
Current methods for preparing allergenic extracts face inefficiencies in removing low molecular weight components, alter the natural structure of allergens, and result in precipitation issues, making them unsuitable for immunotherapy and diagnostic purposes.
Innovation Solution
A process involving cross flow microfiltration, ultrafiltration, and diafiltration to concentrate and purify allergenic extracts without pH adjustment or conductivity testing, eliminating the need for additives and reducing precipitation, thereby producing stable and highly concentrated extracts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If dead end filtration with progressively smaller pore size membranes is used to separate solids from liquids, then clarification and filtration are achieved, but product loss occurs at each stage and multiple clarification steps are required
Solution Approach 1:
The filtration process is segmented into two distinct stages: cross-flow microfiltration for initial clarification removing large particulates, followed by ultrafiltration for fine separation of allergen proteins. This segmentation allows each stage to operate at optimal pore sizes without requiring progressive filtration through multiple decreasing pore sizes, thereby reducing cumulative product loss while achieving the desired clarification quality.
Solution Approach 2:
A cross-flow microfiltration membrane serves as an intermediary stage between crude extraction and ultrafiltration. This intermediary step removes bulk particulates and debris before the ultrafiltration step, preventing clogging and reducing the need for multiple ultrafiltration passes, thus minimizing allergen extract loss while maintaining high clarification standards.
2Manufacturing precision
If multiple clarification and filtration steps are carried out to achieve desired solution clarity, then particulate-free solution is obtained, but time and energy consumption increase
Solution Approach 1:
The clarification process is divided into two specialized stages: cross-flow microfiltration for rapid removal of large particulates and ultrafiltration for fine protein separation. This segmentation allows each stage to be optimized for its specific function, reducing the total number of steps compared to sequential filtration through multiple decreasing pore sizes, thereby decreasing processing time while maintaining high solution clarity.
Solution Approach 2:
The cross-flow microfiltration operates continuously to remove particulates before ultrafiltration, preventing clogging and maintaining steady-state operation. This continuous action eliminates the need for repeated filtration cycles and intermediate processing steps, reducing overall processing time while achieving the desired clarity through coordinated continuous operation of both filtration stages.
3Manufacturing precision
If dead end filtration is used for separation, then solids are removed from liquids, but filter blockage occurs due to high solid to liquid ratio
Solution Approach 1:
Instead of using dead-end filtration where feed is pressed directly against the membrane (causing rapid clogging), the invention uses cross-flow filtration where feed flows parallel to the membrane surface. This inverts the filtration approach, allowing continuous removal of particulates without blockage, ensuring operational continuity while maintaining high separation efficiency for allergen proteins.
Solution Approach 2:
Cross-flow microfiltration acts as an intermediary that handles the high solid-to-liquid ratio feed stream, removing bulk particulates through shear flow that prevents clogging. This intermediary step protects the subsequent ultrafiltration stage from blockage, ensuring operational continuity while maintaining efficient separation of allergen proteins through the coordinated two-stage 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
This process efficiently recovers allergenic extracts with reduced or eliminated precipitation, maintaining the natural form of allergens and achieving high concentrations suitable for therapeutic and diagnostic use.
Implementation Method 1
separating a solid phase from a liquid phase by cross flow microfiltration to remove particulates greater than 0.2 μm-0.8 μm in size
Implementation Method 2
concentrating the crude extract using ultrafiltration to extract and to partially remove low molecular weight molecules (e.g., of less than 5 kDa)
Implementation Method 3
subjecting the concentrated extract to continuous diafiltration to remove remaining lower molecular weight molecules from the concentrated extract
Implementation Method 4
lyophilizing the ultrafiltered and diafiltered extract to obtain the allergenic intermediate
Data Source
AI summary
Disclosed herein are methods for the preparation of allergenic extracts. In one embodiment, the methods are carried out without having to adjust the pH of the extraction phase. The methods provide efficient recovery of allergenic extract from allergenic source material.