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.
Standardizing traceability of personalized cell and gene therapies: dives deeply into the challenges of maintaining chain of custody / chain of identity across organizations and explains how modelling as services and a consistent approach to identifiers is key to scalability and flexibility.
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
Abstract
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. Â
Abstract
There are many differences in manufacturing cell and gene therapies (CGTs) compared to established small molecule and biologics platforms and this profoundly affects the IT systems requirements. Some products are personalized so the process includes personal screening and sequencing data, with traceability and data privacy throughout. Starter cell variability adds complexity to a manufacturing process that must have a rapid turnaround, very dynamic scheduling and rapid deviation management. Outcomes must be tracked for the long term to improve patient outcomes as well as to support novel reimbursement models.Industrialization of CGTs therefore needs the support of advanced systems for manufacturing execution, orchestration, traceability, scheduling, patient data and outcome tracking. Some processes will be encapsulated in closed systems, and there may be analytical requirements for continuous process verification and dynamic adjustment. Operators distributed across the globe will be supported remotely by augmented and virtual reality technologies. This paper helps executives and IT professionals to understand the IT needed to support CGT manufacture, and stimulates collaboration across the industry to meet these challenges.
Abstract
Cell and gene therapies (CGTs) are medicines with enormous potential to create personalized therapeutics for patients with diseases that were once untreatable. However with these opportunities come challenges. One is how IT and CGT teams understand each other’s needs and challenges – only once this knowledge gap is bridged will CGTs be produced and administered commercially. This paper uses analogies to help specialists from CGT and IT to discuss and understand the key issues in commercializing CGTs and important aspects of IT systems and infrastructure. The analogies also reveal those differences in a relatable way that stimulates creativity and joint problem solving, which are critical in this fledgling but fast-growing industry.
Abstract
This document contains a set of reference models explaining who needs to be involved in the supply of different types of Cell and Gene Therapies (CGTs) and, at a very high level, what they do. It can be used by anyone who wishes to better understand the manufacture and delivery of CGTs, and in particular how IT systems can support that.
Abstract
CGTs and their patient-specific delivery of therapeutics are seen by many as the future of medicine. However, the field of CGT manufacture is currently immature and typically involves multiple organizations in the delivery of a single CGT treatment. As well as the established biomanufacturers, there are many small players who are attempting to scale up from lab-based processes. Many of these CGT companies are working to establish their IT requirements, but there is no common understanding of a pharma company’s ‘normal’ CGT needs or those of the multiple organizations and experts involved.Resources
IT for CGT: Digital capabilities for cell and gene therapy
IT can be simple: Using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies
CGT actors and process maps: Who does what in the supply of different cell and gene therapies
