## 2 Advantages of On-Site Hospital Facilities
### Investment in Infrastructure and Personnel  
Significant investment in infrastructure, equipment, and personnel is essential when establishing in-house GMP facilities [14]. Constructing, qualifying, and maintaining pharmaceutical cleanrooms requires extensive capital. Specialized manufacturing and monitoring equipment suited for cell processing must be purchased and qualified. The costs of infrastructure, alongside expenses for consumables and testing, highlight the value of efficient facility designs that maximize productivity. Recruiting personnel with appropriate backgrounds in cell therapy process development, GMP manufacturing, quality control, quality assurance, and regulatory experience is crucial but challenging given this field's novelty. Finding personnel with experience in clinical cell bioprocessing is not always simple. Staff availability can limit capacity, so manufacturing strategies maximizing operator productivity can enable hospitals to meet clinical demand within personnel constraints [5]. Extensive planning and financial investment are critical for establishing the necessary infrastructure, staff, training, and multi-departmental coordination for hospital ATMP facilities, to effectively transition new therapies from research to clinical application. This transition is especially pertinent when integrating emerging technologies like AI, where financial considerations are paramount. The study by [PERSON] et al. underscored the importance of economical scalability in cell therapy manufacturing, highlighting the potential of small-scale microfactories as a cost-effective approach before progressing to larger-scale macrofactories [15; 16]. This model calls for careful economic assessment, particularly in automating processes to enhance efficiency and reduce costs, while maintaining quality control and managing the variability in donor cell characteristics. This strategy of balancing innovation with sustainability can serve as a template for AI integration in ATMP manufacturing, and it may even promote and facilitate clinical integration [17; 18]. Infrastructure, equipment, and personnel training represent substantial investments, especially for smaller-scale academic facilities involved in the production of CAR-T cells, a type of ATMP. These upfront investments are pivotal due to the high costs associated with CAR-T cell manufacturing, which can reach approximately USD 400,000 per therapy production. However, integrating AI in this process offers a promising opportunity to reduce these costs. AI's ability to analyze and interpret data can significantly improve the efficiency and cost-effectiveness of CAR-T cell production by automating the multi-step manufacturing process, allowing comprehensive data collection. Such automation not only directly lowers high manufacturing costs but also aids in optimizing logistics and scaling production. Moreover, AI technologies could assist in identifying suitable patients for therapy, monitoring therapy progression, and predicting treatment responses. However, creating an AI-based CAR-T cell therapy system also raises challenges such as data privacy, data security, and the requirement to integrate AI systems into existing workflows. Ultimately, reducing contamination incidents and batch failures through AI can boost usable outputs, with forecasts suggesting that the total cost of goods may decrease by up to 18%, thus enhancing process sustainability. These benefits cannot be realized until there are verifiable use cases, combined with increased maturity in major capabilities such as blockchain technology and digitalization, highlighting the clear economic incentives and reduction in barriers to AI adoption of ATMP manufacturing [19; 20]. Additionally, it is a fact that decentralized manufacturing has emerged as a crucial strategy in the cell and gene therapy arena, not just revolutionizing production landscapes but also addressing staffing and training challenges.