VacciRAPTOR: High-throughput, Continuous Flow-Through System for Psoralen-UVA Inactivation

Dengue virus is a mosquito-transmitted pathogen that is a significant global health concern, affecting millions annually and causing severe disease and death. The limitations of current Dengue vaccines necessitate innovate approaches to vaccine development. This proposal introduces a novel solution: PsoraVAX-DEN, an inactivated vaccine that harnesses the unique advantages provided by pathogen inactivation with UV light in the presence of a psoralen photosensitizer in an industrialized, continuous flow format to rapidly produce safe and effective vaccines for Dengue at a scale that satisfies increasing global demand.áThe VacciRAPTOR technology, developed by the Rapid Prototyping Laboratory at Colorado State University and optioned to Solaris Vaccines, facilitates high-throughput inactivation resulting in efficient, large-scale vaccine production. The system is designed to precisely control the intensity and duration of exposure to specific wavelengths of UV light in the presence of photosensitizing chemicals, such as the flavin psoralen. This results in the ideal balance between disrupting pathogen genetic material while preserving key antigen structures. Advantages of this approach include continuous flow for high-throughput inactivation, enhanced antigen preservation, potential for multivalent vaccine formulations, low-cost vaccine production, and the facilitation of local manufacturing to support global health needs. Our goal is to apply this innovate approach to the production of an inactivated Dengue vaccine. The Phase II work will build on the progress made during Phase I, with the primary goal of inactivating 50 L volumes of Dengue using a VacciRAPTOR optimized for psoralen/UV-A.áPrimary technical objectives include:Hardware, software and disposable upgradesSystem testing and complianceOptimization and scale-up of dengue virus growth, inactivation and purificationEvaluation, optimization and validation of in vitro assaysSafety testing in miceSuccessful completion of the Phase II SBIR will result in complete, optimized vaccine production process for 50L volumes of Dengue virus, including growth, inactivation using VacciRAPTOR, and subsequent downstream processing.á