Integrated Cell Harvesting System for Scalable Therapy Manufacturing
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Solution Overview
Problem
The complexity in manufacturing cell therapies due to the lack of standardization in cell isolation, expansion, and harvesting processes, which hinders the scalability of cell therapies to treat a large number of patients, and the need for separate instrumentation and techniques for each step in the upstream manufacturing process.
Innovation Solution
A system comprising a housing with a fluid pump, valve, magnet, fluid processing reservoir, filter, and flexible tubes for cell harvesting and isolation, using magnetic cell capture beads and a magnet to selectively capture desired or undesired cell types, allowing for efficient separation and purification within a unified ecosystem.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If separate instrumentation and techniques are used for each step of cell isolation, expansion and harvesting, then each step can be optimized independently, but the overall manufacturing process becomes complex and difficult to scale
Solution Approach 1:
The patent combines multiple cell processing functions (isolation, expansion, harvesting) into a single integrated instrument with unified control, eliminating the need for separate instrumentation for each step while maintaining optimization capabilities through modular process protocols
Solution Approach 2:
The instrument is designed as a universal platform capable of performing multiple cell therapy manufacturing operations through a single device, using configurable process parameters and modular components to adapt to different cell types and processing requirements
2Productivity
If multiple separate systems are used for cell therapy manufacturing, then each system can be specialized, but standardization is lacking and scalability is hindered
Solution Approach 1:
The integrated instrument incorporates modular, replaceable components and standardized interfaces that allow individual modules to be optimized for specific functions while maintaining overall system integration and standardization across different manufacturing operations
Solution Approach 2:
A single universal instrument platform performs all cell therapy manufacturing steps with standardized protocols and control systems, enabling consistent, scalable production across different cell types and therapeutic applications
3Adaptability or versatility
If a unified system is used for all cell processing steps, then standardization and scalability improve, but the system must handle diverse cell types and processes
Solution Approach 1:
The instrument provides universal functionality for diverse cell processing applications through configurable process parameters, modular components, and standardized protocols that can be adjusted for different cell types and therapeutic requirements
Solution Approach 2:
The system incorporates dynamic, programmable control systems and adjustable process parameters that allow real-time optimization for different cell types and processing steps, enabling a single device to adapt to diverse manufacturing requirements
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 system streamlines the cell therapy manufacturing process by enabling efficient cell harvesting and isolation, reducing the need for multiple instruments and techniques, and allowing for scalable production while ensuring high product quality and patient safety.
Implementation Method 1
a magnet (9) arranged to selectively engage with said filter (8) when the filter (8) is inserted into the housing
Implementation Method 2
adding magnetic cell capture beads to said fluid processing reservoir wherein said magnetic capture beads selectively bind either to a specific undesired cell type or to a specific desired cell type
Data Source
AI summary
This present invention provides means for cell harvesting and isolation to be carried out with a single apparatus. This represents a more convenient way for the processing of cells compared with known methods and represents a useful development for the manufacture of cell therapies.