Nanotoxicity Assessment in Biomedical Applications of Nanomaterials

Nanomaterials offer transformative potential in diagnostics, drug delivery and regenerative medicine, yet their unique physicochemical attributes can provoke unintended biological responses. Assessment of nanotoxicity integrates characterisation of size, shape, surface chemistry and aggregation state with evaluation of biological interactions across molecular, cellular and organ‐level scales. Common mechanisms of toxicity include oxidative stress driven by reactive oxygen species, inflammation mediated by cytokine release and genotoxicity arising from DNA damage. In vitro platforms—ranging from two-dimensional cell cultures to advanced three-dimensional organoids—provide high-throughput screening but require careful control of assay interferences owing to nanomaterial reactivity. In vivo models and computational simulations further inform on biodistribution, clearance kinetics and long-term effects. Standardisation efforts are under way to harmonise protocols, define relevant endpoints and integrate mechanism-based biomarkers. Comprehensive nanotoxicity assessment is critical to ensure the safe translation of nanomedicines, align with regulatory guidelines and address global health challenges.

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Technical terms

Reactive oxygen species (ROS): Partially reduced oxygen derivatives that can damage lipids, proteins and DNA when generated in excess.

Nanozyme: A nanomaterial engineered to mimic the catalytic activity of natural enzymes, often used for redox-based therapies.

In vitro toxicity assay: Laboratory test performed on cultured cells to measure adverse effects of substances under controlled conditions.

Organoid: Three-dimensional multicellular structure derived from stem cells that replicates key features of an organ for more physiological testing.

Physicochemical properties: Intrinsic material characteristics—such as size, shape, surface charge and composition—that influence biological interactions and toxicity.

References

1. Safety Landscape of Therapeutic Nanozymes and Future Research Directions. Advanced Science (2024).
2. Hazard assessment of nanomaterials using in vitro toxicity assays: Guidance on potential assay interferences and mitigating actions to avoid biased results. Nano Today (2024).
3. Nanoparticles‐induced potential toxicity on human health: Applications, toxicity mechanisms, and evaluation models. MedComm (2023).
4. Physicochemical Properties of Nanomaterials: Implication in Associated Toxic Manifestations. BioMed Research International (2014).