HelioSAFE-2: A Platform for the Fast, Label-Free, Automated Evaluation of Sterility

There is a critical need within the Department of Defense (DoD) and the medical countermeasure (MCM) development community to rapidly manufacture biologics such as nucleic acid products and proteins (e.g., antigens, monoclonal antibodies) in varying quantities (gram to kg scales). These products can be used both as MCM and for other industrial processes such as enzyme-catalyzed reactions. Importantly, sterility testing is performed on MCMs to confirm that they are contaminant-free.  Sterility testing is typically performed by taking a percentage of the total reagent or cellular inputs as well as the products to be tested in each manufactured batch. There are several limitations to current sterility testing methods, which are time-consuming and costly Therefore, a method that can provide rapid, small sample volume, fully automated, small footprint, low power requirements, and in-line sterility testing would constitute an ideal solution to overcome critical bottlenecks. Toward this end, HelioWave Technologies, LLC, proposes to advance the development of its HelioSAFETM system for rapid, label free automated sterility testing. This effort will involve validating the performance of the system using a panel of biological contaminants, including bacterial cells, bacterial spores, and fungi. In addition, the system will be tested using a variety of sample types derived from nucleic acid and protein therapeutic and medical countermeasure (MCM) workflows. In addition, the project will advance the development of the HelioSAFETM system toward FDA qualification and finalize the performance characterization of the device and detection hardware for scale-up manufacturing. Finally, Finally, we will subject the HelioSAFETM system to independent verification and validation testing to ensure it meets performance expectations. Taken together, these activities will deliver novel, rapid, and low-cost sterility testing that will positively impact biopharmaceutical manufacturing workflows.