Allergenic Extract Ultrafiltration to Prevent Viral Filter Clogging
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Solution Overview
Problem
Existing methods for producing allergenic extracts for immunotherapy are inadequate in removing viral and mycoplasmic contaminants, leading to potential infections and immunological interference, and suffer from clogging issues during viral filtration, which compromises yield and standardization.
Innovation Solution
A process involving a viral ultrafiltration step using a filter assembly with a pre-filter and main filter to remove viruses and mycoplasmas while preserving allergenic proteins, ensuring a purified extract free of contaminants and maintaining protein content, with standardized production times.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If viral filtration is implemented to remove viruses and mycoplasmas, then product safety is improved, but filter clogging occurs reducing productivity
Solution Approach 1:
The filtration system is segmented into multiple stages: a pre-filtration step using filters with larger pore sizes (0.2-0.5 μm) to remove larger viral particles and mycoplasmas, followed by a main filtration step using ultrafiltration membranes with smaller pore sizes (1-10 kDa molecular weight cutoff) to remove smaller viral particles. This segmentation prevents clogging of the main filter while ensuring comprehensive viral removal, thus maintaining both product safety and filtration efficiency
Solution Approach 2:
The pre-filtration step is performed before the main ultrafiltration step to remove larger contaminants that would otherwise clog the ultrafiltration membranes. This preliminary action protects the main filter system, extends membrane life, and maintains high filtration efficiency throughout the process while ensuring thorough viral and mycoplasmic removal
2Manufacturing precision
If stringent viral removal methods are used, then product purity is improved, but allergenic protein yield is reduced
Solution Approach 1:
The ultrafiltration process parameters are optimized by selecting appropriate molecular weight cutoff values (1-10 kDa) that create a size-based separation threshold. This parameter selection allows the process to retain larger allergenic proteins (typically >10 kDa) in the retentate while removing smaller viral particles and mycoplasmas in the permeate, thus achieving high product purity without significant loss of allergenic protein yield
3Device complexity
If conventional filtration is used to maintain simple process, then device complexity is reduced, but viral removal effectiveness is insufficient
Solution Approach 1:
Ultrafiltration membranes serve as an intermediary technology that bridges conventional filtration and advanced viral removal methods. These membranes can be integrated into existing filtration infrastructure with minimal modifications, maintaining process simplicity while providing enhanced viral removal effectiveness through their selective pore structure and size-based separation mechanism
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 achieves purified allergenic extracts free of viruses and mycoplasmas, ensuring safety and stability, while avoiding clogging and maintaining yield, and is standardized across different batches and protein species.
Implementation Method 1
a viral ultrafiltration step, said ultrafiltration being functional to obtain a finished product substantially free of viruses and/or mycoplasmas
Implementation Method 2
a filter assembly comprising a pre-filter, upstream of the main filter
Data Source
AI summary
Process for producing a finished product containing or consisting of a purified allergenic extract, the process comprising the steps of: (A) providing a crude allergenic extract, the crude allergenic extract being obtained by isolation from a biological sample; (B) optionally, cleaning the crude extract, to obtain a clean crude extract, the cleaning step comprising the sub-steps of (B1) filtering the crude extract to remove the microbial load native to the biological sample; (C) optionally, purifying the crude extract or the clean crude extract, to obtain a purified extract, the purification step comprising the sub-steps of (C1) filtering the crude extract or the clean crude extract to remove impurities having a molecular weight ≤5,000 Da; the process being characterized in that it comprises a viral ultrafiltration step functional to obtain a finished product substantially free of virus and/or mycoplasma, which contains or consists of a purified extract of the allergen.The patent application also concerns products for medical use or for diagnostic use, comprising one or more allergen extracts substantially free of viruses and/or mycoplasmas native to the starting biological sample or from any external contamination.