Manufacturing cell and gene therapies (CGTs) usually involve the coordinated efforts of staff in treatment centres, shipping partners, and more than one manufacturing facility. It has become complex because each new therapy seems to define a contrasting way of doing things and has a different way of interacting across various combinations of the same companies. So how can we align processes? And how can we get to a level of digital maturity?...
IT for CGT
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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.
Cell and gene therapies (CGTs) and their patient-specific delivery of therapeutics are often seen as the future of medicines. However, CGT manufacture is complex and typically involves multiple organizations delivering a treatment. In such complex ecosystems of delivery partners, it is vital to define who does what, and how it is all orchestrated. A new BioPhorum document contains a set of reference models explaining who needs to be involved in...
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.
Cell and gene therapies (CGTs) have enormous potential to create personalized therapeutics for patients with diseases that were once untreatable – but they come with some challenges. Many of these are because the end-to-end process differs from conventional biologics and, crucially, requires new IT capabilities. When rapidly bringing new therapies to market, it is challenging to work out a practical IT architecture and investment strategy that...
IT can be simple: Using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies
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.
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.