Semi-Automatic Aseptic Kit for TIL Isolation and Cryopreservation
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Solution Overview
Problem
Current methods for isolating tumor-infiltrating lymphocytes (TILs) from tumors are labor-intensive, require strict aseptic conditions, and often result in cell damage due to oxygen deficiency and improper processing, leading to suboptimal viability and diversity of the final cellular product.
Innovation Solution
A semi-automatic aseptic tissue processing method using a single-use aseptic kit with interconnected modules for disaggregation, enrichment, and stabilization, which minimizes contamination and operator exposure, allowing for efficient processing and cryopreservation of TILs with reduced cell damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual isolation methods are used for TILs, then processing flexibility is maintained, but labor intensity increases and processing time extends
Solution Approach 1:
The system is divided into separate functional modules: a disaggregation module for tissue breakdown, an enrichment module for TIL isolation, and a stabilization module for cell preservation. Each module performs a specific function in the TIL processing workflow, enabling automated operation while maintaining modularity and ease of implementation.
2Reliability
If traditional processing methods are used, then equipment simplicity is maintained, but contamination risk increases and aseptic conditions become difficult to maintain
Solution Approach 1:
The system extracts and isolates the TIL processing workflow into a closed automated system that operates independently from the external environment. The automated modules handle tissue disaggregation, enrichment, and stabilization within a controlled environment, eliminating the need for manual intervention and thereby maintaining strict aseptic conditions while reducing contamination risk.
3Manufacturing precision
If prolonged processing is performed, then complete TIL isolation is achieved, but cell viability decreases due to oxygen deficiency and damage
Solution Approach 1:
The system performs preliminary stabilization of the isolated TILs immediately after enrichment by transferring them to a stabilization module containing preservation medium. This preliminary action prevents cell degradation and maintains viability by protecting cells from oxygen deficiency and damage during the processing workflow, enabling complete isolation without compromising cell health.
4Ease of operation
If manual handling is used, then equipment simplicity is maintained, but operator exposure to hazardous materials increases
Solution Approach 1:
The automated system performs the entire TIL processing workflow independently without requiring operator intervention. The modules automatically execute disaggregation, enrichment, and stabilization procedures, eliminating operator exposure to hazardous biological materials while maintaining ease of operation through automated control and monitoring.
Data Source
AI summary
The present invention provides methods for isolating and cryopreserving tumor infiltrating lymphocytes (TILs) and producing therapeutic populations of TILs, including methods via use of a kit and a semi-automatic device for aseptic disaggregation, enrichment, and cryopreservation of a resected tumor prior to expansion of the TIL population. The present invention also provides methods for expansion, and/or stabilization of TILs, for instance UTILs, compositions involving the same and methods of treatment involving the same.