Patient-Specific TIL Manufacturing for Adaptive Treatment Scheduling
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for manufacturing tumor infiltrating lymphocytes (TILs) for adoptive cell therapy face challenges in achieving reliable and efficient expansion, requiring large quantities of irradiated allogeneic cells and high doses of IL-2, and lack a robust process for scheduling treatment events based on dynamic cell expansion parameters.
Innovation Solution
A framework for coordinating TIL manufacturing that includes dynamic scheduling of patient treatment events and accurate tracking of biological material, using computing devices to manage cell expansion processes and ensure compliance with acceptance criteria, thereby optimizing logistics and patient safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If rapid expansion process (REP) is used to expand TILs, then expansion speed and efficiency are improved, but large quantities of irradiated allogeneic cells and high doses of IL-2 are required
Solution Approach 1:
The system dynamically adjusts expansion parameters including IL-2 dosing schedules and feeder cell ratios based on real-time monitoring of TIL proliferation rates and cell viability, allowing optimization of expansion efficiency while reducing total consumable requirements
Solution Approach 2:
Real-time monitoring of expansion parameters and cell characteristics provides feedback to adjust cultivation conditions, enabling precise control of expansion magnitude while minimizing excessive consumption of IL-2 and feeder cells
2Productivity
If large excess of irradiated allogeneic cells are used as feeder cells, then TIL expansion is supported, but process complexity and cost increase
Solution Approach 1:
The system optimizes the ratio of feeder cells to TILs and adjusts IL-2 dosing parameters to achieve effective expansion with reduced feeder cell requirements, simplifying the overall process while maintaining productivity
Solution Approach 2:
Instead of using large excess of all components, the system applies targeted optimization to critical parameters only, using sufficient but not excessive amounts of feeder cells combined with optimized IL-2 timing to achieve effective expansion with simplified logistics
3Loss of time
If dynamic scheduling of treatment events is implemented, then patient treatment timing is optimized, but system complexity increases
Solution Approach 1:
The system performs preliminary scheduling of treatment events based on projected expansion outcomes, allowing advance preparation of logistics and patient scheduling while maintaining flexibility to adjust based on actual expansion progress
Solution Approach 2:
The coordination system integrates multiple functions including expansion monitoring, treatment scheduling, logistics coordination, and compliance tracking into a single platform, managing complexity through functional integration rather than separate systems
4Reliability
If accurate tracking of biological material is maintained, then material integrity is ensured, but measurement and tracking difficulty increases
Solution Approach 1:
The system creates digital replicas and records of biological material characteristics and movement history, allowing accurate tracking and verification without requiring complex physical monitoring of each sample throughout the process
Data Source
AI summary
A method for coordinating the manufacturing of an expanded cell therapy product for a patient may include receiving a cell order request to expand the cell therapy product for the patient; generating a patient-specific identifier or cell order identifier associated with the cell order request; and initiating a process to expand the cell therapy product from at least some of a solid tumor obtained from the patient. If acceptance parameters for the expansion cell therapy product do not meet certain acceptance criteria at a second time point subsequent to a first time point in the expansion process, it is determined whether re-performing the expansion of the cell therapy product using the cell expansion technique is possible from the first time point based on the acceptance parameters at the second time point. If such re-performing the expansion is possible, patient treatment events that use the expanded cell therapy product are rescheduled.