AIDPATH - Modular Manufacturing Platform for AI-enabled hospital-based ATMP Production

The automation and scale-up of ATMP manufacturing is a pathway to shorten vein-to-vein time and improve therapy availability. Current manufacturing processes are labor intensive complex manual pro-cesses. State-of-the-art automated ATMP manufacturing system have been a step in the right direction but miss out on efficient scalability as they rely on up-numbering approaches to increase the productivity of a manufacturing site. Traditional manufacturing approaches also rely on centralized production which introduces shipping delays as the cells need to be transported in a frozen state, requiring complex infrastructure. Decentralization, ATMP production at the point of care, could reduce the need for complex transportation networks and shorten vein-to-vein time to improve patient care.
The AIDPATH project aims to build such a decentralized automated production platform capable of producing chimeric antigen receptor (CAR) T cells in the hospital. To support the production process, the platform will integrate hospital and patient data to schedule the manufacturing steps as well as optimize the parameters for the production using trustworthy AI-technology. The AI will be supported using data from the LogiqCare platform where all the data relevant to the product is stored in accordance with GDPR (EU 2016/679) guidelines.
This talk presents the AIDPATH physical platform. An automated CAR-T manufacturing system with integrated quality control. The platform employs a closed handling focused approach to enable the parallel manufacturing of multiple patient’s therapies while excluding the possibility of cross-contamination. Integrated in-line quality control provides cell count, viability and identity to the control system which uses them for process adaption and optimization. Finally, the laboratory automation concept including the software framework for seamless device integration is presented.