Modular Closed Cell Therapy Manufacturing With Interchangeable Modules
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Solution Overview
Problem
Current cell therapy manufacturing processes require multiple devices, leading to significant labor allocation, high infrastructure costs, and lack of modularity due to predefined systems that cannot easily accommodate device exchanges.
Innovation Solution
An automated, reconfigurable, and modular closed system for cell therapy manufacturing, featuring a master device with a controller, input and output devices, and removably coupled auxiliary devices for various processing steps, allowing for customizable and efficient cell processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple separate devices are used in the manufacturing process, then various cell therapy manufacturing steps can be performed, but significant labor allocation and high infrastructure costs are required
Solution Approach 1:
The patent combines multiple separate cell therapy manufacturing devices into a single integrated platform. The modular system allows different processing modules (enrichment, selection, activation, expansion, formulation) to be merged into one cohesive system that performs all necessary manufacturing steps, thereby reducing the number of separate devices and infrastructure requirements while maintaining full manufacturing capability
Solution Approach 2:
The integrated platform is designed with universal functionality to perform multiple cell therapy manufacturing steps through interchangeable modules. The system can adapt to different cell types and manufacturing protocols by configuring different module combinations, providing multi-functional capability that replaces multiple specialized devices
2Reliability
If predefined systems are used, then manufacturing processes can be supported, but the systems are not modularized and cannot easily accommodate device exchanges
Solution Approach 1:
The system is divided into independent, interchangeable modules that can be separately designed, manufactured, and exchanged. Each module performs a specific function (enrichment, selection, activation, expansion, formulation) and can be independently optimized or replaced without affecting the entire system, enabling both reliable process support and flexible adaptability
Solution Approach 2:
The system transitions from static predefined configurations to a dynamic modular architecture where modules can be easily added, removed, or exchanged based on manufacturing needs. This dynamic configuration allows the system to adapt to different cell therapy protocols and requirements while maintaining process reliability through standardized interfaces and control
3Object-affected harmful factors
If a closed system is used, then contamination risks are minimized, but the system requires automation to maintain efficiency
Solution Approach 1:
The system incorporates automated control mechanisms that enable self-monitoring and self-regulation of critical parameters (temperature, pressure, flow rates, cell counts). The automated system performs quality control, process monitoring, and parameter adjustment without human intervention, maintaining the closed environment's contamination barrier while ensuring operational efficiency and consistency
Data Source
AI summary
Embodiments of automated closed apparatus for cell therapy manufacturing are provided herein. In some embodiments, an automated closed apparatus for cell therapy manufacturing includes: a master device having a master controller for processing control programs for a variety of cell types; an input device fluidly coupled to the master device, wherein the input device is configured to feed an initial plurality of cells to the master device; one or more auxiliary devices each configured to perform one or more cell therapy manufacturing steps to the initial plurality of cells to form a final plurality of cells; and an output device coupled to the master device configured to collect the final plurality of cells from the master device.