Cell and gene therapies (CGTs) is an emerging, high-growth area, but their manufacture is different from established small molecule and biologics platforms in many ways. These range from starter cell variability and traceability for patient safety, to the need for fast turnarounds, very dynamic scheduling and rapid deviation management. All of these, and more, profoundly affect the IT system requirements for CGT.
As more CGTs are approved for commercial use each year, so the challenge of manufacturing consistently, cost-effectively and to tight timescales increases exponentially. So how can IT systems make this possible? BioPhorum’s Digital capabilities for cell and gene therapy answers this question by helping business and IT leaders to clearly understand the IT needed to support CGT manufacture. It shares the in-depth challenges of digital support for CGTs and sets out a vision to help realize their extraordinary potential.
Written by BioPhorum’s IT-CGT workstream, the paper creates a foundation for collaboration with a growing group of industry stakeholders to define solutions and long-term roadmaps. It therefore outlines a program of work for the team to deliver and covers nine topics such as manufacturing execution, orchestration, traceability, scheduling, patient data and outcome tracking.
There is a huge amount of activity in CGT and the BioPhorum vision document is stimulating collaboration between biomanufacturers, contract development and manufacturing organizations, and equipment and software vendors. It will be useful for IT and non-IT professionals, as well as software and equipment suppliers who wish to understand how evolving IT and digital capabilities are integral to advances in CGT manufacturing.
The commercialization of CGTs can only be achieved by combining new processes and IT. By using this vision document, companies will be able to understand a set of digital capabilities that will accelerate preparations to manufacture CGTs and support their scalability.