One-day rapid sterility test for human-derived biopharmaceuticals

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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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