R. Weber, M. O’Connor , S. Antoszczyk., M. Weber
Keywords: microbial detection, bio-burden, real time, in-line
Summary:Throughout the production of next generation pharmaceuticals, prevention of microbial contamination is crucial. Standard growth-based detection methods require a minimum 14-day incubation, a period which often exceeds the shelf-life and delays release of cell therapies, gene therapies, and CAR-T treatments (1). To improve patient safety and enhance quality control of drug production, new rapid microbial detection methods are required. Fluid-Screen aims to enable real-time sterility testing and bio-burden by capturing and identifying microbial contaminants in 30 minutes. This method utilizes dielectrophoresis (DEP) and electroosmosis (EO), electromagnetic phenomena which influence particle motion in fluids. Fluid-Screen has designed a novel microfluidic chip configured for high-volume throughput drug processing. Our studies have demonstrated separation of Escherichia coli and Mycoplasma species from mammalian cell culture, label-free microbial viability, and >99% bacterial capture efficiency. Fluid-Screen presents microbial capture technology that is for the first time suitable for high precision sterility testing. Culture-free microbial detection allows for real-time results. CAR-T and gene therapy products will be released to patients in hours instead of days. With faster detection capabilities than current methods, Fluid-Screen demonstrates the potential to establish 30 minutes a new standard for microbial detection in biomanufacturing. 1. R.S. Tirumalai. USP Proposes a New Chapter for Rapid Sterility Testing, BioPharm International, 2018,31 (9).