Biomaterial Purification Using Cationic Complexes and Staple Fiber Filtration
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Solution Overview
Problem
Existing methods for purifying biomaterials, such as proteins and antibodies, face challenges with high levels of process-related impurities like host cell proteins and DNA, which can lead to fouling of downstream processes and require higher pressure drops, making current recovery and purification methods inefficient and time-consuming.
Innovation Solution
A method involving the use of a cationic polymer to form a bio-polymer complex with near-neutral and negatively charged impurities, followed by separation through a vessel filled with loosely packed staple fibers, allowing for efficient recovery of the target biomolecule.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If high-density cell cultures are used to increase antibody titers, then productivity is improved, but the level of process-related impurities increases, leading to fouling of downstream filtration processes
Solution Approach 1:
The patent applies preliminary action by performing a pre-filtration step using a depth filter before the main membrane filtration process. This preliminary filtration removes larger particles and reduces the load on subsequent filtration stages, preventing fouling while maintaining high productivity from high-density cell cultures
Solution Approach 2:
The patent segments the filtration process into multiple stages: a depth filtration stage followed by a membrane filtration stage. This segmentation allows different filtration mechanisms to address different impurity sizes, effectively handling the high impurity levels from high-density cultures without compromising productivity
2Manufacturing precision
If conventional filtration processes are used to remove impurities, then purification is achieved, but pressure drops increase and process time is extended
Solution Approach 1:
The depth filter performs preliminary removal of larger particles and organic matter before the membrane filter processes the liquid. This pre-treatment reduces the burden on the membrane filter, decreasing pressure drops and process time while maintaining effective purification
Solution Approach 2:
The depth filter acts as an intermediary device that protects the membrane filter from direct contact with high-concentration impurities. By intercepting larger particles and reducing organic load beforehand, it extends the operational life of the membrane filter and reduces overall process time
3Manufacturing precision
If conventional filtration processes are used to remove impurities, then purification is achieved, but pressure drops increase
Solution Approach 1:
The filtration system is segmented into a depth filter stage and a membrane filter stage. The depth filter handles the bulk removal of particles and organics with lower resistance, while the membrane filter provides fine filtration. This segmentation distributes the pressure drop across stages, maintaining lower overall pressure drops while achieving effective purification
Solution Approach 2:
The depth filter performs preliminary removal of particles and organics before the membrane filter operates. This pre-treatment reduces the concentration of fouling agents reaching the membrane filter, thereby reducing pressure drops during the filtration process while maintaining purification effectiveness
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 approach effectively reduces the time and pressure required for purification, enabling more efficient separation of target biomolecules by forming a bio-polymer complex that can be easily filtered, thus overcoming the limitations of traditional methods.
Implementation Method 1
contacting a cationic polymer and the aqueous biological composition to form a mixture comprising a bio-polymer complex and the target molecule
Implementation Method 2
adding the mixture to a filtering volume of a vessel, wherein the vessel comprises loosely packed staple fibers; allowing the mixture to separate through the loosely packed staple fiber
Data Source
AI summary
Described herein is a method of purifying a target molecule from an aqueous biological composition, the method comprising: (a) contacting a cationic polymer and the aqueous biological composition to form a mixture comprising a bio-polymer complex and the target molecule in a liquid, wherein the bio-polymer complex has an average particle diameter of at least 45 micrometers, (b) adding the mixture to a filtering volume of a vessel, wherein the vessel comprises loosely packed staple fibers; (c) allowing the mixture to separate through the loosely packed staple fiber; and (d) collecting a filtrate comprising the target molecule.