In the second reporting phase of the AIDPATH project, significant strides were made across various work packages. The consortium defined manufacturing SOPs, production sequence diagrams, and material flow mappings for the automated CAR-T cell platform. Despite an eleven-month delay in PLC component delivery, the automated system's design was finalized, and hardware build-up commenced, with ongoing integration of the PLC cabinet and LHU programming. CE certification and GMP documentation progress, including risk analysis and operator's manual, are subcontracted.
Ethics meetings, though delayed, remain essential for addressing concerns. Collaboration between different partners focused on GMP-compliant documentation, qualification, validation, and risk analysis. Experimental work, guided by Design of Experiments, generated high-throughput datasets for CAR-T manufacturing, enhancing the understanding of crucial process parameters. We could also presenting concepts and methodologies for AI modules and actively contributing to Project Board and Executive Group discussions.
The provision of SOPs for production, the optimization of CAR-T production through small-scale experiments and the preparation for the introduction of the AIDPATH platform were also covered. The Bioreactor FACER prototype can be customized now, refining single-use cartridges, hardware, and software. Variants of T-cell culture media are being developed to operate the bioreactor and perform biological experiments for process optimization. Databases are also provided, which are crucial for CAR-T therapy and AI training.
Successfully developed soft sensors for adaptive control and monitoring in AI use case 2, which will be integrated into the newly developed AI-COPE interface. The LogiqSuite structure for managing medical data was further developed and prepared for patient planning and AI use case 5. Furthermore, surveys and workshops were conducted to capture the trust and acceptance of the stakeholder groups. This contributed to the social guideline and the development of the business model.
Overall, AIDPATH's second phase demonstrated progress in hardware build-up, AI module development, regulatory approaches, and stakeholder engagement. Ongoing collaboration, despite delays, sets the stage for the platform's final implementation, emphasizing its potential impact on personalized CAR-T cell therapy.
