Prefilter System for Biological Purification
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Solution Overview
Problem
Current purification systems for biological streams face significant challenges with non-specific binding (NSB) species, which compete with desired proteins for binding sites and irreversibly bind to affinity materials, reducing yields and capacity, especially in affinity chromatography and ultrafiltration systems.
Innovation Solution
A prefilter system utilizing hydrophobic, lipophilic, and charged entities such as activated carbon, ion exchange beads, and particles like silica or silicates is introduced to remove NSB species before they reach the purification systems, thereby reducing competition for binding sites and fouling of ultrafiltration membranes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If affinity chromatography and ultrafiltration systems are used to purify biological streams, then desired proteins can be captured from liquid streams, but non-specific binding species compete for binding sites and clog ultrafilters, reducing yields and capacity
Solution Approach 1:
The patent applies preliminary action by introducing a prefilter system before the main affinity chromatography and ultrafiltration systems. This prefilter removes non-specific binding species (NSB) from the liquid stream upstream, preventing them from reaching and interfering with the downstream purification systems. The prefilter performs the removal action in advance, so when the cleaned stream enters the affinity column or ultrafilter, NSB species are already eliminated, thus maintaining high yields and capacity without compromising the desired protein capture efficiency
2Object-affected harmful factors
If affinity media is washed with various buffers and chemical washes to remove NSB species, then some NSB may be removed, but the affinity ligand Protein A is susceptible to denaturing under these conditions, reducing overall capacity
Solution Approach 1:
The patent applies segmentation by dividing the purification system into distinct functional segments: a prefilter system for NSB removal, followed by the affinity chromatography system, and then ultrafiltration. This segmentation allows the NSB removal function to be performed separately by the prefilter using gentle methods (hydrophobic, lipophilic, or charged entities) that do not denature Protein A, while the affinity media can then operate at full capacity without needing aggressive washing that would damage the ligand
Solution Approach 2:
The prefilter acts as an intermediary component between the crude lysate and the affinity chromatography system. It mediates the removal of NSB species through its specialized media (hydrophobic entities, lipophilic entities, activated carbon, charged entities, or particles like silica and controlled pore glass) before the stream enters the affinity column, thereby protecting the Protein A ligand from exposure to harsh cleaning conditions while still achieving effective NSB removal
3Object-affected harmful factors
If ultrafilters are cleaned with caustic solutions to remove NSB species, then membranes become free of NSB, but this does not extend filter life and fouling still occurs during filtration
Solution Approach 1:
The prefilter performs preliminary removal of NSB species from the liquid stream before it reaches the ultrafilter. By eliminating NSB upstream through its specialized media (hydrophobic, lipophilic, charged entities, or particles), the prefilter prevents fouling from occurring in the first place during ultrafiltration operations, thereby extending filter life without requiring frequent caustic cleaning cycles
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 prefilter system enhances the yield and capacity of affinity chromatography media, extends the lifetime of ultrafiltration systems, and reduces fouling by effectively removing NSB species, leading to higher overall capacity and longer system lifespan.
Implementation Method 1
Suitable agents include but are not limited to hydrophobic entities; lipophilic entities; activated carbon; charged cation or anion entities such as ion exchange beads or powders; ligands; particles such as fumed silica, controlled pore glass or derivitized version of each; silica or silicates
Data Source
AI summary
The present invention is to a prefilter for purification systems such as affinity chromatography columns and ultrafiltration systems. The prefilter, positioned upstream of the system inlet, reduces the presence of non-specific binding (NSB) species that enter the system, thereby extending the yield, capacity and lifetime of the system. Suitable agents include but are not limited to hydrophobic entities; lipophilic entities; activated carbon; charged cation or anion entities; ligands; particles such as fumed silica, glass, controlled pore glass or derivitized version of each; silica or silicates; and combinations thereof. The material(s) can be incorporated into a variety of media such as fibers, beads, membranes and the like and then incorporated into a variety of device designs including lenticular pads, depth filters, bead containing columns, spiral wound devices, TFF devices and the like.