Biomedical Applications of Synthetic Biology

Abstract

Synthetic biology re-engineers living cells to perform programmable therapeutic, diagnostic, and manufacturing functions that natural biology does not provide, yet the clinical translation of synthetic-biology-based biomedical products remains slow and uneven across application domains. We evaluated 220 synthetic biology programmes targeting biomedical applications across research centres in Switzerland and Italy between 2014 and 2024, spanning five application categories: engineered cell therapies, synthetic gene circuits for diagnostics, microbial living therapeutics, cell-free biosynthesis platforms, and engineered bacteriophage therapies. A Synthetic Biology Biomedical Translational Index (SBBTI) was constructed from five sub-scores -- circuit performance reliability, host-cell genetic stability, biosafety containment adequacy, manufacturing standardisation, and preclinical efficacy demonstration -- with weights from regression against progression to next-phase regulatory milestones. SBBTI correlated with translational advancement at r = +0.84 and discriminated advancing from stalled programmes with an AUC of 0.882. Engineered cell therapies scored highest (mean SBBTI 0.822), while cell-free biosynthesis platforms trailed at 0.598. Only 34.5 percent of programmes exceeded the 0.75 SBBTI threshold. Circuit performance reliability carried the largest regression weight (beta = +0.276), followed by biosafety containment adequacy (beta = +0.232).