IT for cell and gene therapies

Overview

The IT for Cell and Gene Therapies program is a collaboration between leading biopharmaceutical manufacturers, software and equipment vendors, working together to bring about a shared vision for digital maturity in the manufacture of cell and gene therapies.
With many new cell and gene therapies becoming approved for commercial use each year, the challenge of manufacturing consistently, cost-effectively and in tight timescales has increased. Complex manual processes demand immersive training, and digital assist technologies in the clean room. A new range of digital capabilities is needed to trace cells from vein to vein, automate processes, integrate and digitize testing, secure personal data, eliminate delays, and predictively adapt the process to variability in the starting cells and clinical harvesting processes. As they plan the way forward, biomanufacturers must set the right foundations by catching up with best practices in digital manufacturing, support personnel with virtual and augmented reality, and eventually move towards predictive and adaptive processes.
The IT for cell and gene therapy program is creating references and tools to help address some of those issues.

The vision for digital capabilities for cell and gene therapy is targeted to educate IT professionals in the distinctives of cell and gene therapies, so that they are productive faster and the solutions they create have better foundations, support more products, and are more maintainable.

IT can be simple: using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies provides creative and visual ways to bridge the gap of understanding

CGT actors and process maps: Who does what in the supply of different cell and gene therapies describes how the required digital capabilities vary according to the type of cell and gene therapy platform

CGT personas and user stories: What people need the systems to do to support the supply of cell and gene therapies provides a toolkit to support analysis and system design: not just what is needed, but why.

The goal of the program’s ongoing work is to provide consistent approaches with reusable methodologies or frameworks that will help speed up the development of IT architecture to support new modalities.

All of this will accelerate industry alignment and make partnership easier, there’ll be fewer dead-end, unmaintainable, unscalable solutions; more equipment integration and informatics alignment, and better IT foundations to support the future range of CGT products. Ultimately there’ll be fewer deviations and improved patient outcomes.

This case study by Roche (30 mins) describes their approach to CGT orchestration and exception management – an exemplar real-world implementation of the BioPhorum user stories and process maps for CGT. It highlights the strategy and business requirements for a single solution to support multiple therapies in the treatment centers. Within the supply chain a solution is needed to support the new patient operations function, scheduling, personalization, chain of custody, chain of identity and the coordination of multiple manufacturing organizations. From an architectural view these are enabled by a common set of flexibly interchangeable services that can be arranged in different patterns to support the various CGT modalities.

Downloadable documents

Resources

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IT for CGT: Digital capabilities for cell and gene therapy

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IT can be simple: Using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies

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CGT actors and process maps: Who does what in the supply of different cell and gene therapies

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CGT personas and user stories