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One-day rapid sterility test for human-derived biopharmaceuticals
Junwon Kang1,2,3, Hamin Kim1, Haewook Jang1
1Interdisciplinary Program in Bioengineering, Seoul National University, Seoul, Korea.
Nature Biomedical Engineering
|October 1, 2025
Summary
A new nanoparticle-based test rapidly confirms biopharmaceutical sterility in one day. This rapid sterility testing reduces clinical risks and ensures therapeutic efficacy for these vital medicines.
Area of Science:
- Biotechnology
- Microbiology
- Pharmaceutical Science
Background:
- Biopharmaceuticals offer alternatives to traditional drugs but face sterilization challenges.
- Conventional sterility testing methods are too slow for biopharmaceutical shelf lives.
- Current practices often require administering biopharmaceuticals before sterility confirmation, posing clinical risks.
Purpose of the Study:
- To develop a rapid sterility test for biopharmaceuticals.
- To mitigate clinical risks associated with administering unconfirmed sterile biopharmaceuticals.
- To maintain therapeutic efficacy during biopharmaceutical delivery.
Main Methods:
- Utilized a nanoparticle-based enrichment method with synthetic beta-2-glycoprotein I peptides for broad microorganism capture.
- Employed a microfluidic chip for automated monitoring of microbial metabolic activity via fluorescence imaging.
- Inferred microbial growth from the reduction of a non-toxic dye.
Main Results:
- Achieved a turnaround time reduction of over 58 hours compared to conventional methods.
- Demonstrated 100% accuracy in sterility determination.
- Established a limit of detection as low as 1 colony forming unit per milliliter.
- Validated the approach using clinical-grade biopharmaceutical products.
Conclusions:
- The developed nanoparticle-based assay provides rapid and accurate sterility testing for biopharmaceuticals.
- This method significantly reduces the time to sterility confirmation, addressing limitations of conventional techniques.
- The assay mitigates clinical risks and ensures the safety and efficacy of biopharmaceutical products.
