Accelerated sterility testing unlocks safe delivery of life-saving therapies

accelerated-sterility-testing-unlocks-safe-delivery-of-life-saving-therapies
Accelerated sterility testing unlocks safe delivery of life-saving therapies
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Nature Biomedical Engineering (2025)Cite this article

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A synthetic peptide nanoparticle and microfluidic chip enable sterility testing of cell- and gene-based therapeutics in under 18 hours, bridging a long-standing safety gap for biopharmaceutical products that cannot undergo terminal sterilization and have limited shelf life.

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Fig. 1: A sterility test for emerging human-derived biopharmaceuticals.

References

  1. Rader, R. A. (Re)defining biopharmaceutical. Nat. Biotechnol. 26, 743–751 (2008). An article that defines the scope of biopharmaceuticals and their distinction from conventional, chemically synthesized drugs.

    Article  CAS  PubMed  Google Scholar 

  2. Baker, D. J. et al. CAR T therapy beyond cancer: the evolution of a living drug. Nature 619, 707–715 (2023). An article presenting CAR T cells as a living therapeutic that eradicates refractory blood cancers and might also extend to non-cancer diseases.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. Cundell, T., Atkins, J. W. & Lau, A. F. Sterility testing for hematopoietic stem cells. J. Clin. Microbiol. 61, e0165422 (2023). An article that reviews current sterility testing practices for haematopoietic stem cells and discusses strategies to enhance speed and safety in clinical applications.

    Article  PubMed  Google Scholar 

  4. Kim, T. H. et al. Blood culture-free ultra-rapid antimicrobial susceptibility testing. Nature 632, 893–902 (2024). An article that presents a synthetic-peptide nanoparticle for rapid microbial detection in clinical diagnostics.

    Article  CAS  PubMed  Google Scholar 

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This is a summary of: Kang, J. et al. One-day rapid sterility test for human-derived biopharmaceuticals. Nat. Biomed. Eng. https://doi.org/10.1038/s41551-025-01524-3 (2025).

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Accelerated sterility testing unlocks safe delivery of life-saving therapies. Nat. Biomed. Eng (2025). https://doi.org/10.1038/s41551-025-01557-8

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  • DOI: https://doi.org/10.1038/s41551-025-01557-8