Patient-Specific Immunotherapy Tracking System for T Cell Chain of Custody
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Solution Overview
Problem
Current immunotherapy procedures lack a technical mechanism for automatic tracking of patient-specific biological samples, leading to delays and misidentification issues during the manufacturing process, which is critical for patients with life-threatening illnesses.
Innovation Solution
A method and system for performing patient-specific immunotherapy with chain-of-custody and chain-of-identity tracking, involving a computing device that generates a patient-specific identifier and records tracking events for each step of the process, from leukapheresis to infusion, ensuring continuous and automatic tracking of T cells through the manufacturing process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual tracking methods are used for biological samples, then device complexity is reduced, but reliability of sample identification deteriorates
Solution Approach 1:
The patent uses barcodes and RFID tags as digital copies/representations of biological sample identity information. These machine-readable identifiers serve as reliable, error-free copies of patient and sample data that can be automatically scanned and tracked throughout the immunotherapy process, eliminating manual transcription errors while maintaining manageable system complexity through standard tagging technologies.
2Productivity
If automated tracking systems are implemented, then productivity of immunotherapy process is improved, but device complexity increases
Solution Approach 1:
The patent replaces manual mechanical tracking processes with automated electronic identification systems. Barcode scanners and RFID readers automatically capture sample identity information without manual intervention, while software systems automatically update tracking logs and alert personnel to deviations. This substitution of mechanical/manual operations with electronic automation increases process speed and productivity while the modular software architecture keeps system complexity manageable.
3Loss of time
If continuous tracking is performed at each process step, then loss of time due to misidentification is reduced, but use of energy by the tracking system increases
Solution Approach 1:
The patent implements continuous tracking by automatically scanning barcodes or reading RFID tags at each critical process step (sample collection, processing, storage, and administration). This continuous automated identification ensures immediate detection of any misidentification or tracking deviations, preventing delays. The system uses energy efficiently by activating scanners only at designated checkpoints rather than continuous monitoring, and by using low-power RFID technology for passive identification.
Data Source
AI summary
Methods and apparatuses are described for performing a patient-specific immunotherapy procedure. A computing device receives a request to create transfected T cells for a patient. The computing device generates a patient-specific identifier associated with the cell order request. The computing device initiates a process to create transfected T cells for infusion into the patient's bloodstream, comprising: performing a leukapheresis procedure on a sample of the patient's blood to collect T cells from the sample, transferring the collected T cells to a container, labeling the container with the patient-specific identifier, transmitting the collected T cells to a manufacturing facility, creating transfected T cells from the collected T cells using a cell modification technique, receiving the transfected T cells from the manufacturing facility, and infusing the transfected T cells into the patient's bloodstream. The computing device records a tracking event for each step, including the patient-specific identifier, to generate a chain of custody of the patient's T cells.