Continuous Biological Molecule Purification Without Pool Tanks
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Solution Overview
Problem
Conventional purification processes for biological molecules, such as therapeutic proteins, are labor-intensive, time-consuming, and require large holding tanks, leading to high costs and limited manufacturing flexibility.
Innovation Solution
A continuous or semi-continuous process that integrates multiple purification steps, including bind and elute chromatography and flow-through purification, eliminating the need for large pool tanks and reducing the number of steps, with the use of stimulus-responsive polymers and in-line static mixers for virus inactivation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional batch purification processes are used with multiple separate steps and holding tanks, then product purity can be maintained, but purification time and manufacturing costs increase significantly
Solution Approach 1:
The patent combines multiple separate batch purification steps into a single continuous process where clarification, chromatography, and polishing steps are integrated and performed simultaneously in a unified system, eliminating the need for sequential processing and intermediate holding tanks
Solution Approach 2:
The patent implements continuous flow through the purification system where feedstock continuously enters the clarification step, flows through chromatography columns, and proceeds to polishing steps without batch interruptions, maintaining constant productive action throughout the process
2Ease of operation
If large pool tanks are used to store intermediate products between process steps, then solution conditions can be adjusted, but physical footprint and manufacturing flexibility are reduced
Solution Approach 1:
The patent extracts and eliminates the large pool tanks from the process system, replacing them with in-line adjustment mechanisms that modify solution conditions directly within the continuous flow path, removing the need for intermediate storage vessels
Solution Approach 2:
The patent transitions from spatial storage (pool tanks occupying physical space) to temporal control (in-line adjustment within the flow stream), changing the dimension in which solution condition management occurs from spatial to temporal
3Manufacturing precision
If multiple separate batch process steps are performed, then thorough purification can be achieved, but labor intensity and operational complexity increase
Solution Approach 1:
The patent merges multiple discrete unit operations into an integrated continuous system where clarification, chromatography, and polishing functions are combined in a unified process train, reducing the number of separate equipment items and operational interfaces
Solution Approach 2:
The continuous purification system performs multiple purification functions (clarification, chromatographic separation, polishing) within a single integrated process flow, making the system multi-functional and reducing overall process 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 significantly reduces purification time and costs while maintaining product yield, eliminating the need for large pool tanks and reducing the physical footprint, and achieving efficient impurity removal without sacrificing product purity.
Implementation Method 1
a purification step which employs an affinity ligand called Protein A, isolated from Staphylococcus aureus, and which binds the Fc-region of antibodies
Implementation Method 2
one or more downstream chromatography steps to separate the protein of interest from various impurities in the clarified cell culture feed
Implementation Method 3
a cell harvest step, which typically involves use of centrifugation to remove cell and cell debris from a cell culture broth
Implementation Method 4
followed by depth filtration
Data Source
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AI summary
The present invention relates to improved processes and systems for purification of biological molecules, where the processes can be performed in a continuous manner.