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.
“The CGT vision is a collective effort by industry experts to understand and quantify the IT challenges we face when delivering CGT treatments,” said Hernan Vilas, Global Head of Operational Technology and Digital Strategy at Lonza. “We’ve used the vision to support our CGT Business Unit Technology Roadmap to reach our 2022 ambitions. The collaboration has helped us frame and understand the IT challenges in the CGT space and define a digital vision to overcome them.”
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 – manufacturing execution, assisted operations, closed systems, digital telemetry and analytics, advanced scheduling systems, orchestration and traceability, information privacy and security, distributed manufacturing and long-term outcome tracking.
“Engagement with the IT-CGT workstream to develop the vision document has allowed us to work across industry to identify where technology and modern digital solutions can remove barriers,” said Tour Ala, Cell & Gene Therapy Industrialisation IT Lead at Roche. “It will enhance our organization’s ability to deliver these new treatments at scale and improve the lives of a wide population of patients.”
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.
“The vision document will help us reach continuous operational excellence, regardless of complexity, from donor to patient,” said Sebastien Carnel, IT Global Manufacturing – Head of Digital Transformation at Takeda. “By achieving this digital vision, we can make CGT manufacturing adaptable, scalable and robust across the supply chain, leveraging data to prevent variability and enabling CGT products to be affordable for all people who need treatment now and tomorrow.”