SNU researchers develop rapid sterility test that determines pharmaceutical sterility in just one day

Seoul National University College of Engineering announced that a research team led by Professor Sunghoon Kwon from the Department of Electrical and Computer Engineering, in collaboration with Professor Eun Ju Lee from the Department of Biomedical Sciences at Seoul National University Hospital and Professor Tae Hyun Kim from the KU-KIST Graduate School of Converging Science and Technology at Korea University, has successfully developed a rapid sterility test (NEST: Nanoparticle-based Enrichment and rapid Sterility Test) that can determine the sterility of pharmaceuticals within a single day—dramatically shortening the conventional 14-day testing process.

The research findings were published on October 1st in Nature Biomedical Engineering, one of the world’s most prestigious journals in the field of biomedical engineering.

According to the Korean Pharmacopoeia, sterility test is used to confirm that pharmaceuticals or medical devices, which must remain free of microbial contamination, are indeed sterile, and it generally takes 14 days to complete. Recently, this same procedure has been applied to biopharmaceuticals, including cell and gene therapies, which have emerged as new treatment modalities in the pharmaceutical industry. Biopharmaceuticals, the result of advances in modern biotechnology, include CAR-T cell therapies that have cured otherwise fatal blood cancers, mRNA vaccines that changed the course of the COVID-19 pandemic, and monoclonal antibodies, a cornerstone of cancer immunotherapy.

These medicines have cured cancers once considered untreatable and have opened new therapeutic avenues for patients who previously had no treatment options. As their importance grows as the core of future healthcare, the global biopharmaceutical market is estimated to reach approximately USD 400 billion (approximately KRW 550 trillion) in 2024, with projections indicating it will continue to grow at a high rate of over 15% annually.

However, despite this rapid growth and technological advancement, quality control standards for biopharmaceuticals have remained largely based on criteria originally designed for conventional chemical drugs. These standards do not reflect the characteristics of modern biopharmaceuticals, such as cell and gene therapies, which often have extremely short shelf lives of only a few days. As a result, during the two-week sterility testing period, a biopharmaceutical’s efficacy can diminish, forcing clinicians to administer the treatment before sterility validation is complete. This longstanding dilemma—balancing patient safety with therapeutic urgency—has posed a major challenge in advanced medicine.

To address this issue, the joint research team developed NEST, a new sterility testing platform capable of confirming sterility within a single day instead of 14 days. The innovation opens the possibility for safely and timely administration of biopharmaceuticals that have been confirmed sterile.

Inspired by the body’s innate immune system, which detects invading pathogens, the researchers employed magnetic nanoparticles coated with special peptides that selectively bind to a broad range of pathogens. This allows for rapid enrichment of trace microbial contaminants in pharmaceuticals. The team developed a dedicated imaging chip and automated detection system that enable real-time imaging of a high-sensitivity fluorescence assay responsive to the metabolic activity of a broad range of microbes. Taken together, the integrated platform enabled rapid sterility testing that is dozens of times faster and more reliable than conventional methods. Notably, NEST successfully detected extremely low microbial concentrations (as few as one cell per milliliter) within 5 to 18 hours across 14 microbial species.

Furthermore, the researchers validated the system using clinical-grade stem cells and CAR-T cell therapy samples, which can cost several hundred million KRW per dose. The pilot tests confirmed that NEST performed robustly and reliably with real patient samples, demonstrating practical readiness for clinical application.

Professor Eun Ju Lee of the Department of Biomedical Sciences at Seoul National University Hospital explained, “In advanced regenerative medicine, many biopharmaceuticals are administered to patients immediately after production, before the 14-day sterility test can be completed. With NEST, same-day sterility confirmation could soon become possible, leading to significant improvements in patient safety and potentially transforming regulatory frameworks.”

To facilitate clinical implementation, Professor Kwon’s company, QuantaMatrix Inc., a comprehensive microbial diagnostics enterprise, signed a memorandum of understanding (MOU) with Seoul National University Hospital in August to conduct large-scale clinical validation and commercialization of NEST. Seoul National University Hospital, equipped with in-house cell and gene therapy manufacturing infrastructure, will provide real clinical samples for evaluation. QuantaMatrix, which previously co-developed uRAST—a world-first culture-free antibiotic susceptibility testing and pathogen identification system published in Nature in 2024—brings extensive expertise in diagnostic device development, commercialization and clinical implementation. Under the partnership, two NEST systems will be installed at the SNUH Advanced Cell and Gene Therapy Center by the end of this year for performance testing and technology refinement using real-world clinical specimens.

The newly developed technology has broad potential applications beyond biopharmaceuticals, including sepsis diagnostics, food safety testing, cosmetic sterility assurance, and early infectious disease detection. Professor Tae Hyun Kim of Korea University stated, “NEST is not just an academic achievement—it has tremendous potential for expansion across multiple industries. We will continue building clinical data to further enhance its reliability and applicability.”

Professor Sunghoon Kwon of Seoul National University added, “Our goal is to establish this technology as a new global standard for ensuring patient safety. We plan to pursue further validation and clinical applications, while contributing to improvements in both domestic and international regulatory environments.”

The first author, Dr. Junwon Kang, received his Ph.D. in Bioengineering from Seoul National University’s Interdisciplinary Program in February 2025 and is currently a postdoctoral researcher at the Korea Institute of Science and Technology (KIST). He has developed pioneering technologies for rapid bacterial detection and antibiotic susceptibility testing, including a sepsis diagnostic platform that eliminates the need for traditional blood culture steps, and a rapid sterility verification platform for pharmaceuticals. Dr. Kang continues to collaborate with industry and Seoul National University Hospital to translate these technologies into clinical use, expanding his research to neonatal sepsis diagnostics, environmental monitoring, and pneumonia modeling systems aimed at advancing the detection and management of infectious diseases.

□ Introduction to the SNU College of Engineering

Seoul National University (SNU) founded in 1946 is the first national university in South Korea. The College of Engineering at SNU has worked tirelessly to achieve its goal of ‘fostering leaders for global industry and society.’ In 12 departments, 323 internationally recognized full-time professors lead the development of cutting-edge technology in South Korea and serving as a driving force for international development.