Sterile Connector for Direct Cell Transfer
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Solution Overview
Problem
Current methods for preparing cells for administration in adoptive cell therapy are complex and time-consuming, requiring multiple centrifugation steps, sterile welding, and real-time sample counting, which can compromise cell viability and sterility.
Innovation Solution
A simplified method involving transferring cells and diluent into sterile receptacles, connecting them with a fluid dispensing connector, and mixing the contents to create a product-filled sterile receptacle, thereby reducing the number of manipulation steps and time to administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional cell preparation methods are used, then cell viability and sterility are maintained, but the process is complex and time-consuming with multiple centrifugation steps, sterile welding, and real-time sample counting
Solution Approach 1:
The patent combines multiple separate preparation steps into a single closed system operation. Cells are transferred directly from the cryovial into the administration bag through a sterile connector, eliminating the need for separate centrifugation, washing, and sterile welding steps that were previously required. This merging of operations maintains cell viability and sterility while dramatically simplifying the process.
Solution Approach 2:
The patent introduces a sterile connector as an intermediary component that enables direct transfer of cells from the cryovial to the administration bag without compromising sterility. This connector acts as a bridge that eliminates the need for sterile welding operations while maintaining the sterile barrier, thus reducing process complexity without sacrificing reliability.
2Reliability
If conventional cell preparation methods are used, then proper cell processing is achieved, but the time between beginning of cell manipulation and ultimate administration is extended
Solution Approach 1:
The sterile connector is pre-attached to the administration bag, creating a ready-to-use system that receives cells directly from the cryovial. This preliminary preparation eliminates the need for time-consuming sterile welding and multiple processing steps during the actual cell administration preparation, thereby reducing total preparation time while ensuring proper cell processing.
Solution Approach 2:
The patent enables continuous cell transfer from the cryovial through the sterile connector directly into the administration bag without interruption for centrifugation, washing, or sterile welding operations. This continuous process maintains cell viability and ensures proper processing while minimizing the time cells are outside optimal conditions, thus reducing preparation time.
3Reliability
If multiple centrifugation and sterile welding steps are performed, then cell preparation is thorough, but the number of manipulation steps increases
Solution Approach 1:
The patent merges centrifugation, washing, and sterile welding operations into a single closed-system transfer step. The sterile connector enables direct cell transfer from cryovial to administration bag, eliminating the need for separate manipulation steps while maintaining the quality outcomes previously achieved through multiple operations.
Solution Approach 2:
The patent extracts and removes the need for centrifugation and sterile welding steps from the cell preparation process. By using the sterile connector for direct transfer, these manipulation steps are completely eliminated, reducing the number of operations required while maintaining cell preparation quality through the closed-system approach.
Data Source
AI summary
The current disclosure describes simplified methods of preparing cells for patient infusion where the simplified methods result utilize less steps than conventional methods, decreasing required manipulation steps and reducing the time between beginning of cell manipulation for administration and ultimate administration to a patient. Methods of cryopreserving, thawing, and diluting cells and kits for practicing the methods are also provided herein.