Bioreactor Fluid Delivery Consumable for Sterile Dose Transfer
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Solution Overview
Problem
Existing cell and gene therapy manufacturing processes are complex and require improved equipment for efficient fluid transfer to bioreactors, which are sensitive to manipulations and affect scalability and reproducibility.
Innovation Solution
A fluid delivery consumable comprising a vial with an outlet, a plunger, and a connector that attaches to a bioreactor, allowing for controlled transfer of fluids such as magnetic bead or virus suspensions using a needle that pierces seals to maintain sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If manual or semi-automated steps with multiple devices are used for fluid transfer, then flexibility in handling different cell types and processes is maintained, but the complexity of the manufacturing process increases and reproducibility decreases
Solution Approach 1:
The patent combines multiple functions into a single integrated fluid delivery consumable. The consumable integrates the vial for holding fluid, the plunger for urging fluid toward the outlet, the seal for maintaining sterility, and the connector for attachment to the bioreactor. This merging of functions into one disposable unit simplifies the overall manufacturing process while maintaining adaptability for different cell types and processes.
Solution Approach 2:
The fluid delivery consumable is designed as a universal device that can be used across different cell and gene therapy manufacturing processes. The standardized connector interface allows attachment to various bioreactor types, while the consumable can handle different fluid types (cell suspensions, media, reagents). This multi-functionality reduces the need for process-specific customizations and improves reproducibility.
2Ease of manufacture
If multiple separate devices and connecting tubes are used for cell transfer, then ease of cleaning and sterilization between uses is improved, but the time required for setup and operation increases
Solution Approach 1:
The patent employs a disposable fluid delivery consumable that is used once and then discarded. This eliminates the need for cleaning and sterilization of the consumable components between uses. The connector and seal are designed to be disposed of after a single use, which removes time-consuming sterilization steps while maintaining sterility during the single use through the integrated seal design.
Solution Approach 2:
The consumable is pre-assembled with the connector and seal in place before use. The seal is already positioned to maintain sterility, and the connector is pre-configured for attachment to the bioreactor. This preliminary assembly eliminates setup time during the actual manufacturing process, as the consumable is ready for immediate use upon removal from packaging.
3Reliability
If a connector with hollow needle and seal is used to maintain sterility, then the reliability of sterile fluid delivery is improved, but the device complexity increases
Solution Approach 1:
The connector, hollow needle, and seal are merged into a single integrated consumable unit. The hollow needle is positioned within the seal, and both are attached to the vial as one assembly. This integration maintains sterility through the seal design while reducing the number of separate components that would need to be assembled and managed, thereby reducing operational complexity.
Solution Approach 2:
The connector assembly with hollow needle and seal is designed as a disposable component that is discarded after single use. This eliminates the need for complex sterilization and maintenance procedures that would be required for reusable connectors. The reliability of sterile delivery is achieved through the sealed design that prevents contamination during use, while the disposable nature simplifies the overall system by removing the need for complex sterilization infrastructure.
Data Source
AI summary
The present disclosure provides a fluid delivery consumable for delivering a fluid dose to a bioreactor. The fluid delivery consumable includes a vial for holding the fluid dose, a plunger, and a connector. The vial includes an outlet and an open end opposite to the outlet. The plunger is engaged with the open end and operable to urge the fluid dose toward the outlet. The connector is proximal to the outlet and attachable to the bioreactor. The connector is adapted to transfer the fluid dose from the vial to the bioreactor when the plunger is operated to urge the fluid dose out of the outlet of the vial.