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Background Engineered Living Materials (ELMs) are an emerging class of controlled drug delivery systems that integrate living cells with engineered material scaffolds to enable localized, sustained and adaptive therapeutic release. By combining synthetic biology, materials engineering and delivery science, ELMs extend beyond passive drug diffusion to support environmentally responsive production, feedback-regulated dosing and prolonged site-specific therapeutic activity. Objective This review critically examines the design strategies underlying ELM-based drug delivery systems, with a focus on the molecular mechanisms governing therapeutic payload synthesis, secretion and material-mediated transport. It also evaluates the therapeutic applications, translational potential and regulatory considerations associated with ELM technologies. Key findings ELMs can deliver a diverse range of therapeutic payloads and provide distinct advantages over conventional delivery platforms through dynamic and programmable therapeutic functions. Current applications include gastrointestinal disorders, oncology, immunomodulation, regenerative medicine and localized infection control. The review highlights how biological control systems and engineered material scaffolds can be systematically integrated to achieve precise and sustained therapeutic outcomes. Major translational challenges include ensuring safety, genetic and functional stability, biosafety, scalable manufacturing and regulatory compliance. Translational perspective Application of Quality-by-Design (QbD) principles provides a framework for addressing critical challenges in ELM development, including process control, product consistency and risk assessment. Integrating biological engineering with material and regulatory strategies may facilitate the clinical translation of living drug delivery systems and support the development of future precision therapeutics. Conclusion ELMs represent a transformative approach to controlled drug delivery by enabling adaptive, localized and long-term therapeutic functions. Strategic integration of synthetic biology, material engineering and translational design principles has the potential to accelerate the clinical adoption of ELM-based therapies and redefine future precision medicine paradigms.
Korram et al. (Tue,) studied this question.