Applications of synthetic biology in biomedicine

Based on the principles of engineering reconstruction and programmable design, synthetic biology is driving a paradigm shift in biomedical diagnosis and therapy from conventional models toward intelligent and precision medicine. By constructing artificial genetic circuits, functional cells, and biomaterial systems both in vitro and in vivo, synthetic biology markedly enhances diagnostic sensitivity, therapeutic targeting, and clinical benefit. In recent years, with the maturation of key technologies such as DNA synthesis and assembly, computational modeling, gene editing, RNA regulation, and protein engineering, synthetic biology has spawned numerous applications with potential for clinical translation in fields such as early screening for pathogens and tumors, programmable cellular immunotherapies, intelligent life-based therapies, and the manufacture of medical biomaterials. Nevertheless, current synthetic biology systems still face critical bottlenecks such as insufficient targeting and editing precision in vivo, poor functional stability of gene circuits, pronounced immunogenicity risks, high manufacturing costs, and lagging ethical and regulatory frameworks. This review systematically summarizes progress in foundational tools and key supporting technologies of synthetic biology, highlights innovative strategies and clinical value in biosensors, cell therapy, living therapeutics, and smart biomaterials, and provides an in‑depth comparison of different chassis cells, delivery vectors, and regulatory circuits in terms of disease suitability, safety, and translational efficiency. The artificial intelligence (AI)-enabled component design, closed-loop intelligent regulation, off‑the‑shelf universal cells, and multimodal theranostic platforms are also discussed. This review offers a systematic framework from technical principles to clinical translation and provides theoretical support and technical guidance for developing next-generation synthetic biology-based diagnostic and therapeutic strategies.