Automated Cell Processing System with Disposable Sterile Circuit
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Solution Overview
Problem
Current methods for processing biological fluids, such as blood or blood components, often rely on reusable apparatus and disposable fluid circuits, which can be complex and require substantial operator intervention, limiting efficiency and sterility in separating and preparing cellular products for target cell selection.
Innovation Solution
A system comprising a reusable separation apparatus controlled by a microprocessing unit, configured with a disposable sterile circuit featuring a porous membrane, automates the processing of biological fluids by removing platelets, resuspending, incubating with agents, and separating target cells from non-target cells, reducing operator involvement and enhancing sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a reusable processing apparatus with disposable fluid circuit is used, then sterility is improved, but device complexity increases
Solution Approach 1:
The system is divided into reusable processing apparatus and disposable fluid circuits, separating sterile single-use components from expensive reusable equipment. The disposable circuit includes pre-assembled containers and tubing that can be discarded after one use, eliminating sterilization requirements for the reusable apparatus.
Solution Approach 2:
Disposable fluid circuits are used instead of sterilizable reusable circuits. These inexpensive single-use circuits include pre-sterilized containers and tubing that are discarded after one use, ensuring sterility without requiring complex sterilization systems on the reusable apparatus.
2Productivity
If automated processing is implemented, then productivity is improved, but device complexity increases
Solution Approach 1:
The reusable processing apparatus is designed to perform multiple functions including washing, processing, incubating, and selecting biological cells. The system can handle different cellular products and process types using the same apparatus with disposable circuits, reducing overall system complexity while maintaining high productivity.
Solution Approach 2:
The system is designed to minimize operator intervention during the processing cycles. The automated apparatus performs operations autonomously, reducing labor requirements and increasing productivity without requiring overly complex manual control systems.
3Manufacturing precision
If multiple processing cycles are performed, then manufacturing precision is improved, but loss of time increases
Solution Approach 1:
The processing system performs multiple separation and washing cycles in continuous sequence without interruption. The disposable fluid circuit allows for uninterrupted processing through multiple cycles, maintaining high separation precision while minimizing idle time between operations.
Solution Approach 2:
The disposable fluid circuit is pre-assembled and pre-sterilized before use, with containers and tubing prepared in advance. This preliminary preparation eliminates setup time during processing and allows immediate initiation of multiple sequential cycles for high-precision separation.
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 system enables efficient, automated processing of biological fluids, improving the separation and preparation of cellular products for target cell selection while maintaining a sterile environment, thereby enhancing the efficiency and reliability of cellular product processing.
Implementation Method 1
a separator comprising a porous membrane and in communication with the cellular product
Data Source
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AI summary
A method for automated processing of a cellular product comprising target substrate cells, the method comprising providing a separation apparatus configured to associate with a disposable sterile circuit comprising a separator in communication with the cellular product. The apparatus and disposable sterile circuit are configured to remove platelets from the cellular product to form a platelet-depleted cellular product, resuspend the platelet-depleted cellular product in media to form a resuspended platelet-depleted cellular product, receive an agent having an association with the target substrate cells of the resuspended platelet-depleted cellular product, incubate the agent with the target substrate cells over a period sufficient for the agent to bind with and/or enter the target substrate cells to form a first mixture comprising agent-target substrate cell complexes, unbound/unassociated agent, and non-target substrate cells, and remove unbound/unassociated agent to form a second mixture comprising the agent-target substrate cell complexes and non-target substrate cells.