NeuroGenetics: An AI-Driven Autonomous Integrated Platform for Engineered Immune Cell Therapy — First Application in Acute Leukemia

This paper presents NeuroGenetics, a conceptually designed AI-integrated autonomous platform for the end-to-end production, personalization, and in-vivo guidance of engineered immune cells targeting hematological malignancies, with a primary proof-of-concept focus on acute leukemia. The proposed system integrates eight sequential biomanufacturing stages, ranging from automated T-cell isolation to controlled-rate cryopreservation. These stages are coordinated by a Central Intelligence Core (CIC) capable of in-silico pre-validation, autonomous quality control, and adaptive protocol optimization using federated machine learning techniques. A key innovation of the framework is its dual-track engineering architecture. Path A produces acoustogenetically conditioned CAR-T killer cells, while Path B develops CRISPR-dCas9-based gene-silencing constructs for use in sensitive anatomical environments. Both pathways are designed for remote modulation via a wearable Smart Patient Disc utilizing piezoelectric micromachined ultrasonic transducers (pMUT), enabling patient-specific acoustic signaling for in-vivo regulation of engineered cellular activity. The system further incorporates a Medical Cognitive Memory Unit (MCMU), which securely records experimental and clinical outcomes to ensure traceability and support a continuous closed-loop learning cycle for system improvement. NeuroGenetics conceptually integrates validated technologies from leading biotechnology and engineering platforms, including Miltenyi Biotec, Lonza, MaxCyte, Cytiva, Emulate Bio, Thermo Fisher Scientific, NVIDIA, and Siemens, while proposing a unified orchestration framework for their coordinated use. Key technical challenges such as software fragmentation, cell handling loss, quality control latency, and sensor drift are addressed through proposed engineering mitigation strategies aligned with current biofoundry research directions.