Three-tier framework for high-throughput biofabrication: Integrating 3D bioprinting, assistive platforms, and translational opportunities.

The field of biofabrication is rapidly evolving, yet it faces persistent challenges, including long manufacturing latency, slow throughput, issues with reproducibility, and scalability limitations. High-throughput biofabrication (HTBF) has emerged as a powerful strategy which is presented here to address these gaps through a structured, three-tier framework. Tier 1 encompasses core HTBF methods, such as multi-modal bioprinting and robotic bioassembly, which enable the rapid fabrication of large, physiologically relevant tissue constructs. Tier 2 comprises assisting platforms, including microfluidics and microphysiological bioreactors, which provide perfusion, mechanical conditioning, multiplexable sensing, and process parallelization. Tier 3 represents HTBF outcomes, including organoids, organ-on-a-chip systems, and engineered tissue grafts that deliver clinically and pharmacologically relevant insights. These advancements enable the development of in-vitro models that streamline drug testing, making it more cost-effective and efficient, while enhancing the accuracy and reliability of preclinical drug evaluation. This review defines HTBF by outlining its core characteristics and framework, presenting insights into recent technological advancements and their applications in regenerative medicine and drug discovery. Additionally, it addresses the regulatory and clinical translation challenges that must be resolved to facilitate the adoption of HTBF in personalized healthcare.