A Flexible Digital Twin Framework for ATMP Production – Towards an efficient CAR T Cell Manufacturing

This paper presents a flexible digital twin framework tailored for the biomanufacturing of advanced therapeutic medicinal products (ATMPs), particularly focusing on chimeric antigen receptor T cell (CAR T cell) therapy. CAR T cell therapies face significant challenges in the management of their personalized and complex biomanufacturing processes. To tackle these issues, we propose a novel software framework for a digital twin system aimed at digitalizing, monitoring, and managing the physical production processes. The framework has a hierarchical architecture that methodically organizes production into distinct abstraction levels: processes, tasks and skills, and microservices. This layered architecture simplifies the modeling of complex biomanufacturing production and ensures that each component can be individually updated without disrupting the overall system. Furthermore, the digital twin framework integrates both manual and automated operations within a unified system, accommodating varied requirements of diverse tasks in production. The framework’s flexibility enables easier adaptation to dynamic technological advancements and allows for swift modifications in production processes, making it a sustainable and resilient digitalization infrastructure for ATMP manufacturing.