Standardizing traceability of personalized cell and gene therapies

With personalized cell and gene therapies (CGTs), it is critical that the patient receives the therapy that has been made specifically for them. We must therefore demonstrate end-to-end control by tracing the starting materials collected from the patient through to the administration of the finished product to that same patient. Traceability means that evidence must be collected to show that the chain of identity and chain of custody are intact.  

A number of IT providers offer isolated or disconnected solutions to tackle portions of this challenge. However, the proliferation of slightly different approaches creates a cognitive load for the people involved, increasing the chances of human error while also obstructing a fully integrated approach. Traceability is an issue that impacts the whole process and systems architecture, and should not be seen as a single-system solution.  

This document presents a practical vision and reasoning for standardizing the traceability of CGTs across the value chain. A user-centric design perspective leads to an architecture that integrates interrelated services and a model for connecting data across the systems throughout the supply chain.  It considers the current situation and process flows, envisions a series of user stories from the perspective of several key personas, and outlines the benefits sought from a more holistic approach.  

Using and adhering to the standards outlined in this document will accelerate the analysis of the business challenges and solution designs, highlight key issues to be resolved, and make it easier to align and partner with others working on similar or connected solutions.  

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• File Size 2.16 MB
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• Create Date 24th April 2023
• DOI https://doi.org/10.46220/2023IT002
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