Cell Product Logistics System with Patient-Specific ID Tracking
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Solution Overview
Problem
Existing systems face challenges in managing and providing cell products manufactured from two or more kinds of raw materials derived from the same patient, ensuring the quality and viability of the cells without mixing or confusing the raw materials.
Innovation Solution
A system that assigns an identification code representing patient information to each of the raw materials, transports them in double or multiple packaging containers under specific temperature and time conditions, and combines them at a manufacturing site to produce a cell product, ensuring proper handling and quality maintenance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If two or more kinds of raw materials derived from the same patient are transported to a manufacturing site, then the cell product can be manufactured by combining multiple tissue types, but the risk of mixing or confusing raw materials increases
Solution Approach 1:
The system segments the management of multiple raw materials by assigning unique identification codes to each tissue type (synovium, bone marrow, adipose tissue). Each raw material is tracked independently through the supply chain, allowing multiple tissue types to be combined in manufacturing while maintaining individual traceability and preventing mixing errors.
Solution Approach 2:
The system implements feedback mechanisms through identification code recognition at critical control points. The manufacturing site recognizes and verifies identification codes before combining raw materials, providing continuous feedback on material traceability and enabling real-time verification to prevent mixing errors.
2Loss of time
If raw materials are transported over extended periods, then more time is available for logistics and manufacturing, but cell viability decreases
Solution Approach 1:
The system changes the temperature parameter during transport to optimize cell preservation. By controlling transport temperature and monitoring the product of temperature and time (keeping it at 170°C×days or less), the system extends acceptable transport time while maintaining cell viability at 70% or more.
Solution Approach 2:
The system performs preliminary actions by establishing identification code assignment and temperature control protocols before transport begins. This preliminary preparation ensures that when transport occurs, all parameters are pre-optimized to maintain cell viability throughout the extended transport period.
3Ease of operation
If simple manufacturing process control is used, then the manufacturing process is easier to manage, but it is difficult to appropriately provide cells to treatment with required quality
Solution Approach 1:
The system introduces an intermediary mechanism in the form of identification codes that mediate between simple operational processes and precise quality control. The identification codes serve as intermediaries that carry quality information through the manufacturing process, enabling automated verification and precise tracking without complicating the basic manufacturing steps.
4Productivity
If multiple raw materials are combined at the manufacturing site, then a functional cell product can be produced, but the complexity of tracking and managing materials increases
Solution Approach 1:
The identification code system serves multiple functions simultaneously: it identifies the patient source, tracks the tissue type, verifies material authenticity, and enables combination of multiple raw materials. This universal identification approach manages the complexity of tracking multiple materials through a single integrated system rather than separate tracking mechanisms for each material type.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively provides a cell product that functions as intended, maintaining cell viability at 70% or more, and ensures that the raw materials are not mixed or confused throughout the process.
Implementation Method 1
transported from a medical institution to a manufacturing site under a condition where a product of a temperature (°C) and a number of days (days) in a transport period is 170 (°C × days) or less
Data Source
Figure 1
AI summary
An object of the present invention is to provide a system for finally providing one kind of a cell product in a state where it functions as a cell product without mixing or confusing raw materials in a case where the cell product is manufactured using two or more kinds of tissues derived from the same patient. According to the present invention, there is provided a system for providing a cell product including: an identification step of assigning an identification code representing patient information to two or more kinds of raw materials derived from the same patient; a first transport step of transporting the two or more kinds of raw materials to which the identification code is assigned from a medical institution to a manufacturing site under a condition where a product of a temperature (°C) and the number of days (days) in a transport period is in a predetermined numerical range; a manufacturing step of manufacturing a cell product by recognizing the identification code and combining the two or more kinds of individual raw materials into one product; and a second transport step of transporting the cell product from the manufacturing site to the medical institution.