Cellular Therapy Manufacturing State Machines for Interruption Recovery
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Solution Overview
Problem
Existing systems for manufacturing cellular therapies, such as CAR T-cell therapy, lack efficient methods to resume manufacturing processes after interruptions, leading to significant losses and inefficiencies.
Innovation Solution
A bioprocessing system that utilizes a state machine with a decision tree and sub-state machines, along with an external system for storing states and variables, allows for the resumption of manufacturing by determining the last executed sub-state machine and applying user inputs to resume the process, including recovery processes and safe mode maintenance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manufacturing processes are interrupted for any reason, then equipment utilization decreases and downtime increases, but existing systems lack efficient recovery methods leading to significant losses
Solution Approach 1:
The system performs preliminary actions by continuously saving the state of the manufacturing process at regular intervals and maintaining a decision tree with multiple branches that pre-plans recovery paths. When an interruption occurs, the system can immediately retrieve the last saved state and resume from that point without requiring manual intervention or restarting the entire process, thus minimizing downtime and maximizing equipment utilization.
Solution Approach 2:
The system implements feedback mechanisms by monitoring the manufacturing process state, detecting interruptions, and automatically triggering recovery procedures. The decision tree provides feedback loops that allow the system to adapt to different interruption scenarios and resume operations based on the actual state captured during the interruption, ensuring continuous productivity.
2Ease of manufacture
If manual resumption procedures are used after interruption, then process recovery is simple to implement, but manufacturing precision and consistency are compromised
Solution Approach 1:
The system performs self-service by automatically detecting interruptions, retrieving the last saved state from storage, and resuming the manufacturing process without requiring manual intervention. The decision tree automatically determines the correct recovery path based on the saved state, ensuring that process consistency and precision are maintained while eliminating the need for complex manual resumption procedures.
Solution Approach 2:
The system creates a copy of the manufacturing process state at regular intervals and stores it externally. When an interruption occurs, this state copy serves as a template for resumption, allowing the system to exactly replicate the state before interruption and maintain manufacturing precision without manual intervention.
3Device complexity
If the entire manufacturing process is restarted after interruption, then system complexity is reduced, but productivity and time loss increase significantly
Solution Approach 1:
The system segments the manufacturing process into discrete states and sub-states that can be independently saved and resumed. Instead of restarting the entire process, the system identifies the specific segment where the interruption occurred and resumes only from that point. This segmentation approach maintains relatively simple system architecture while dramatically improving productivity by avoiding unnecessary re-execution of completed process steps.
Data Source
AI summary
A method is provided for resuming a bioprocessing system that is configured to manufacture cells for a cellular therapy. The method, performed by one or more processors and using the bioprocessing system, comprises: executing one or more first sub-state machines, of a plurality of sub-state machines for manufacturing the cells; storing, in an external system, a plurality of states; based on detecting an event, pausing the manufacturing of the cells; based on receiving user input indicating to resume the manufacturing of the cells, retrieving a saved state from the external system; comparing the saved state with the state machine to determine a sub-state machine, from the one or more first sub-state machines, that was most recently executed by the bioprocessing system prior to pausing the manufacturing of the cells; and resuming the manufacturing of the cells based on the determined sub-state machine.