亚洲首台 CellXpress.ai 体外模型智能化工厂在沪成功安装

Core Insights - The successful installation of Asia's first CellXpress.ai in vitro model intelligent factory marks a significant milestone in the strategic collaboration between Danaher Group's Molecular Devices and the Shanghai National Engineering Research Center for Biochips [2][3]. Industry Transformation - The FDA Modernization Act 2.0, enacted in 2022, has fundamentally transformed the preclinical research landscape by recognizing non-animal testing alternatives, allowing the use of organoid models, organ-on-a-chip technologies, and AI algorithms for drug safety and efficacy assessments [3]. - A policy update from the FDA in April 2025 mandates the gradual elimination of mandatory animal testing for specific drugs, integrating organoid and organ-on-a-chip technologies with AI into the regulatory framework [3]. Technological Advancements - The CellXpress.ai platform automates the entire 3D biology process through AI-driven monitoring, cultivation, imaging, and scheduling, significantly reducing manual labor and enhancing efficiency [4]. - Key innovations of the CellXpress.ai system include: - Continuous operation 24/7, ensuring strict control over cultivation and passage schedules, thereby minimizing manual intervention [4]. - Standardized output through AI analysis, providing consistent and physiologically relevant results [4]. - Enhanced growth and expansion efficiency for various stem cell lines and organoids, optimizing screening processes [4]. Broader Implications - The deployment of the CellXpress.ai factory addresses long-standing challenges in the commercialization of organoid technology, such as operational complexity and reproducibility issues [5]. - The integration of organoid technology is expected to accelerate drug development, improving the efficiency of drug safety and efficacy evaluations in response to regulatory demands [5]. - Establishing a national standard for organoid technology is anticipated, promoting the standardized development of this field in China [5]. - The collaboration aims to enhance academic exchanges and training, contributing to the cultivation of high-quality professionals in the organoid industry [5].