Biosensors and Nanotheranostics

Bionanotechnology, Drug Delivery, Therapeutics | online ISSN 3064-7789
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Biosensors and Nanotheranostics 5 (1) 1-8 https://doi.org/10.25163/biosensors.5110980

Submitted: 27 November 2025 Revised: 20 January 2026  Accepted: 28 January 2026  Published: 30 January 2026 


Abstract

Few technologies have entered medicine with as much expectation as nanotechnology. By engineering materials between 1 and 100 nm, the scale of proteins and nucleic acids, researchers have built carriers that home in on tumours, contrast agents that reveal lesions invisible to conventional imaging, and lipid vehicles that made mRNA vaccination possible during the COVID-19 pandemic. Yet the properties that make these materials useful, namely their small size, large reactive surface, and ability to cross biological barriers, also make their behaviour in the body and the environment hard to predict. This integrative review deliberately brings together the clinical, toxicological, ethical, and regulatory literature, usually read in isolation. Peer-reviewed studies, reviews, and regulatory documents published between 2004 and 2026 were identified through structured database searching and citation tracking, then charted and synthesised thematically across four domains. The evidence suggests that clinical maturity is uneven: liposomal and albumin-bound chemotherapeutics, iron-oxide contrast agents, and mRNA-lipid nanoparticle vaccines are established, whereas theranostic, regenerative, and brain-targeted platforms remain largely preclinical. Toxicological concerns converge on oxidative stress, autophagic and lysosomal dysfunction, reticuloendothelial accumulation, and fibre-like pathogenicity of high-aspect-ratio carbon nanotubes, alongside poorly characterised occupational and ecological exposure. Ethically, nanomedicine seems less to create new dilemmas than to intensify familiar ones, notably informed consent under uncertainty, data privacy, enhancement, and a widening "nano-divide". Regulation remains fragmented between product-based and precautionary models. We argue that safety-by-design, mechanism-based alternative testing, harmonised definitions, and early public engagement are urgently needed if nanomedicine is to deliver its benefits safely and fairly.

Keywords: nanomedicine; engineered nanomaterials; targeted drug delivery; nanotoxicology; ecotoxicology; nanoethics; ELSI; regulatory science; alternative testing strategies

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