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Nat. Biomed. Eng., Published: 01 October 2025 | https://doi.org/10.1038/s41551-025-01524-3 One-day rapid sterility test for human-derived biopharmaceuticals

Junwon Kang^1,2,3,14, Hamin Kim^1,14, Haewook Jang^1,14, Hyelyn Joo¹, Soobin Lee⁴, Gi Yoon Lee⁴, Hyoung Jin Kang^5,6,7, Youngmin Kim⁸, Tae Hyun Kim^9,10, Sunghoon Kwon^1,4,11,12 & Eun Ju Lee ^8,13

¹Interdisciplinary Program in Bioengineering, Seoul National University, Seoul, Korea.
²Integrated Major in Innovative Medical Science, Seoul National University, Seoul, Korea.
³Biomaterials Research Center, Korea Institute of Science and Technology, Seoul, Korea.
⁴Department of Electrical and Computer Engineering, Seoul National University, Seoul, Korea.
⁵Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
⁶Department of Pediatrics, Seoul National University Children’s Hospital, Seoul, Korea.
⁷Seoul National University Cancer Research Institute, Seoul, Korea.
⁸Interdisciplinary Program in Stem Cell Biology, Seoul National University College of Medicine, Seoul, Korea.
⁹KU-KIST Graduate School of Converging Science and Technology, Korea University, Seoul, Korea.
¹⁰Department of Integrative Energy Engineering, College of Engineering, Korea University, Seoul, Korea.
¹¹Bio-MAX Institute, Seoul National University, Seoul, Korea.
¹²Inter-university Semiconductor Research Center, Seoul National University, Seoul, Korea.
¹³Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea.
¹⁴These authors contributed equally: Junwon Kang, Hamin Kim, Haewook Jang.

Corresponding authors
Correspondence to Tae Hyun Kim, Sunghoon Kwon or Eun Ju Lee.

Abstract

Biopharmaceuticals are emerging as viable alternatives to chemically synthesized drugs for potential treatment to various diseases. However, many of these human-derived components cannot withstand terminal sterilization procedures, and the duration of conventional sterility testing methods often exceeds their limited shelf life. Consequently, biopharmaceuticals are now frequently administered to patients before sterility confirmation. Here we present a nanoparticle-based enrichment and rapid sterility test that can determine product sterility within a single day, mitigating clinical risks of biopharmaceuticals and maintaining therapeutic efficacies during delivery. The assay incorporates synthetic beta-2-glycoprotein I peptides for selective isolation and purification of a broad spectrum of microorganisms and a microfluidic chip designed to automatically monitor their metabolic activities via fluorescence imaging, which are inferred from the reduction of a non-toxic dye as they grow. Compared with conventional approaches, the turnaround time was substantially reduced by >58 h with 100% accuracy and a limit of detection down to a concentration of 1 colony forming unit per millilitre. We validate our approach using various forms of clinical-grade biopharmaceutical products.

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