Biological Cell Suspension Processing With Automated Single-Circuit Draws
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Solution Overview
Problem
Existing biological cell suspension processing systems face challenges in handling large volumes efficiently, requiring multiple procedures and manual intervention, especially with cryopreserved products, and lack a unified fluid circuit for multiple containers.
Innovation Solution
A system with a reusable hardware unit and disposable fluid circuit that automates the processing of large volumes of biological cell suspensions, allowing one-time data entry for parameters and calculating draws and volumes, using a single fluid circuit for multiple containers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If multiple procedures using multiple fluid circuits are used to process large volumes of biological cell suspensions, then the target concentration of cells can be achieved, but the complexity of the system and manual intervention increases
Solution Approach 1:
The patent combines multiple fluid circuit operations into a single integrated fluid circuit. The system processes large volumes of biological cell suspensions from multiple source containers through one continuous fluid circuit, eliminating the need for multiple separate procedures and circuits while maintaining the ability to achieve target cell concentrations.
Solution Approach 2:
The single fluid circuit is designed to perform multiple functions: it can process cell suspensions from multiple different source containers, handle both cryopreserved and non-cryopreserved products, and achieve various target concentrations through automated control. This multi-functional design replaces the need for multiple specialized circuits.
2Manufacturing precision
If multiple procedures are used to process large volumes of biological cell suspensions, then the target concentration can be achieved, but the processing time increases due to multiple procedures and pooling steps
Solution Approach 1:
The system enables continuous processing of biological cell suspensions through a single uninterrupted fluid circuit. Cell suspensions from multiple source containers are processed sequentially without interruption, eliminating the time lost in stopping, pooling, and restarting between multiple procedures. The automated control ensures continuous operation from start to finish.
3Temperature
If separate disposable fluid circuits are used for each source container of cryopreserved products, then temperature control is maintained, but the number of data entry operations and manual steps increases
Solution Approach 1:
The system performs preliminary setup by allowing the operator to enter all processing parameters once at the beginning, including information about multiple source containers. The automated control system then uses this pre-entered data to manage the entire processing sequence, eliminating the need for repeated data entry for each container while maintaining proper temperature control throughout.
4Device complexity
If a single fluid circuit is used to process large volumes from multiple source containers, then the system complexity is reduced, but automated control of draw volumes and concentrations becomes necessary
Solution Approach 1:
The automated control system incorporates feedback mechanisms to monitor and adjust the processing in real-time. The controller receives information about the cell suspension properties, monitors the draw volumes from each source container, and automatically adjusts parameters to ensure the target concentration is achieved. This feedback loop enables the simplified single-circuit design to operate autonomously with high precision.
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
Enables efficient, automated processing of large volumes of biological cell suspensions with reduced manual intervention, ensuring consistent processing and temperature control for cryopreserved products.
Implementation Method 1
The separation device may be embodied by a spinning membrane separator
Data Source
AI summary
A system and method for processing a biological cell suspension from a source to provide a product in a retentate container comprises a disposable fluid circuit and a reusable hardware unit. The reusable hardware unit comprises a controller which stores processing parameters comprising an estimated volume of biological cell suspension in the source and a concentration of cells in the biological cell suspension. The controller calculates a number of draws of the biological cell suspension and a volume of each draw and calculates a pump speed based on a received processing parameter. The controller controls pumping of the processing solution into the disposable fluid circuit to prime the disposable fluid circuit. The controller directs the withdrawal of the biological cell suspension from the source in batches in accordance with the calculated number of draws and volume of each draw.