PASTA Assembly Resin Capture Bioreactor Purification
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Solution Overview
Problem
Current methods for manufacturing target biological products, such as antibodies and vaccines, require lengthy and costly processes, involving multiple steps from cell growth to separation and purification, which hinders quick production and deployment, especially in emergency situations like counter-terrorism and epidemic responses.
Innovation Solution
A method that integrates cell expression, separation, and purification within a bioreactor using a flexible porous tube assembly (PASTA) containing a resin to capture and elute target biological products, reducing the need for external chromatography columns and filtration steps, and allowing for resin recharging and reuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional multi-step separation and purification processes are used, then manufacturing precision and product purity are improved, but manufacturing time and process complexity increase significantly
Solution Approach 1:
The patent combines multiple separation and purification steps into a single integrated process. The PASTA assembly integrates cell separation, volume reduction, and target product purification into one device that performs all functions simultaneously, eliminating the need for sequential filtration, centrifugation, and chromatography steps.
Solution Approach 2:
The PASTA assembly is designed as a multi-functional device that performs multiple operations: it separates cells from culture medium, reduces volume through ultrafiltration, and purifies the target biological product through selective binding and elution. This single device replaces multiple specialized equipment.
2Manufacturing precision
If traditional chromatography columns with loaded resin are used, then purification effectiveness is improved, but device complexity and resin loss increase
Solution Approach 1:
The PASTA assembly merges the chromatography function with the ultrafiltration membrane structure. The resin is contained within the hollow fibers of the membrane assembly, combining separation and purification functions in one integrated structure rather than requiring a separate chromatography column.
Solution Approach 2:
The patent uses hollow fiber membranes as the structural basis for the chromatography function. These thin-walled flexible fibers contain the resin internally and allow selective passage of molecules, replacing rigid chromatography column structures with a more compact membrane-based system.
3Manufacturing precision
If multiple processing steps are performed externally, then separation and purification quality are improved, but capital investment and operational costs increase
Solution Approach 1:
The patent consolidates multiple external processing steps into a single in-bioreactor operation. The PASTA assembly performs cell removal, volume reduction, and product purification all within the bioreactor vessel, eliminating the need for separate equipment and reducing capital investment.
Solution Approach 2:
The system performs purification functions directly within the bioreactor where the product is produced, using the bioreactor itself as the processing vessel. This self-service approach eliminates the need for transferring materials between multiple external processing units.
4Manufacturing precision
If resin is loaded onto external chromatography columns, then target product capture is improved, but resin loss and waste generation increase
Solution Approach 1:
The hollow fiber membrane structure contains the resin internally within the fibers, preventing loss during handling and operation. The resin is confined within the flexible membrane structure rather than being loose in a column, eliminating spillage and handling losses.
Solution Approach 2:
The resin-containing PASTA assembly is integrated with the ultrafiltration membrane structure, combining the containment function with the separation function. This integration ensures the resin remains contained while performing its capture function, reducing waste.
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 significantly reduces manufacturing costs and time by eliminating several processing steps, enabling faster development and production of biological drugs, and allowing for continuous operation with minimal resin usage and reduced waste.
Implementation Method 1
adding a resin to the bioreactor to capture the target biological product
Implementation Method 2
various buffers used to elute a pure form of target biological product directly from the bioreactor
Implementation Method 3
The resin is contained in a flexible tube that can be removed from the bioreactor
Data Source
AI summary
An assembly capable of capturing and purifying expressed biological products during or at the end of a bioreaction cycle is disclosed wherein a binding resin is kept separated from the contents of the bioreactor allowing capturing, harvesting and purification of biological products in a bioreactor; the invention additionally provides means of removing undesirable metabolic products as well as provides for efficient loading of chromatography columns.