Supply chain digitization

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IT for CGT: Digital capabilities for cell and gene therapy

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.

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BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...

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