Sterile Connection Interface with Integrated Sterilization Chamber
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Solution Overview
Problem
Current methods for producing therapeutic cells for adoptive cell therapy, such as CAR-T cell-based therapy, are time-consuming and expensive due to the complexity and cost of ex vivo enrichment, activation, and genetic modification processes.
Innovation Solution
The development of connection interfaces for sterile connection and liquid transfer that minimize cross-contamination and increase manufacturing efficiency by creating a sterilization chamber between connectors for fluid transfer, using a sterilization agent to ensure a sterile environment, and incorporating pumps and valves to facilitate efficient liquid transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ex vivo enrichment, activation, and genetic modification processes are used for producing therapeutic cells, then therapeutic cells can be produced for adoptive cell therapy, but the production process becomes time-consuming and expensive
Solution Approach 1:
The connection interface is divided into separate sterilizable components (first connector, second connector, housing) that can be independently sterilized and reassembled. This segmentation allows for rapid sterilization of individual parts rather than the entire manufacturing system, significantly reducing the time required while maintaining sterility requirements for therapeutic cell production.
Solution Approach 2:
The connectors and housing are pre-sterilized before assembly, allowing the sterilization process to be completed in advance rather than during the actual cell production process. This preliminary sterilization action enables faster production cycles while ensuring sterile conditions are maintained throughout the therapeutic cell manufacturing process.
2Productivity
If traditional connection methods are used for liquid transfer during cell manufacturing, then fluid transfer can be performed, but cross-contamination risk increases and manufacturing efficiency decreases
Solution Approach 1:
The sterile connection interface acts as an intermediary component between different liquid transfer pathways. The sterilizable housing and connectors create a controlled intermediate zone that prevents direct contact between potentially contaminated surfaces, thereby eliminating cross-contamination risk while enabling efficient liquid transfer during therapeutic cell manufacturing.
Solution Approach 2:
The sterilization chamber is extracted as a separate, removable component that can be independently sterilized. This extraction allows the critical sterilization function to be separated from the main manufacturing equipment, enabling rapid sterilization cycles and reducing the risk of cross-contamination between different production batches while maintaining high manufacturing efficiency.
3Reliability
If sterilization is performed frequently during manufacturing processes, then cross-contamination is prevented, but the process becomes more time-consuming and complex
Solution Approach 1:
The sterilization system is segmented into modular components (sterilizable housing, first connector, second connector) that can be sterilized independently. This segmentation simplifies the sterilization process by allowing each component to be treated separately with appropriate sterilization methods, reducing overall process complexity while maintaining reliable sterility throughout the therapeutic cell manufacturing process.
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 solution enables high-throughput production of therapeutic cells with reduced negative effects on cell growth, minimized risk of cross-contamination, and increased productivity by automating the sterile connection and liquid transfer process.
Implementation Method 1
activating a sterilization agent within the sterilization chamber to produce a sterile environment
Data Source
AI summary
The disclosure includes a system and method for making a sterile connection for transferring a liquid between two containers, including: (a) positioning a first connection surface and a second connection surface; (b) coupling the first connector and the second connector, wherein the coupling defines a sterilization chamber comprising a gap between the first connection surface and the second connection surface; (c) activating a sterilization agent within the sterilization chamber to produce a sterile environment (d) fluidically coupling the first container with the second container through the first connection surface and the second connection surface, (e) transferring a liquid between the first container and the second container.