SBIR-STTR Award

Bioreactors output nucleic acid or protein products that are complex macromolecular fluids. As such, it becomes challenging to discern whether sparse contaminant entities reside within this complex background. Traditional mechanisms of detecting microbe contamination require time consuming and destructive methods with reagents, assay and plating procedures. The COVID-19 pandemic has highlighted the need for the Department of Defense (DoD) to optimize production of life-saving therapeutics and vaccines. HNu Photonics specializes in the creation, fabrication, and implementation of innovative technologies at the forefront of life science research on the International Space Station. HNu’s on-orbit projects have resulted in a variety of techniques and technologies that benefit human endeavors in space and on the ground. The proposed work will harness our existing space-based technology (automated microscopy and microfluidics) to develop a rapid, non-invasive, and automated sterility testing platform for biological materials, FLASH Contaminant Sensing Interrogator (FLASH-CSI). FLASH-CSI will complement DoD efforts by rapidly detecting contaminates within biological processes (antibody or vaccine production) with a non-invasive, triple redundant optical detector. FLASH-CSI is a disruptive technology designed to be an automated contaminate detection facility with a miniaturized footprint to be quickly implemented into existing, remote, or mobile production facilities.

The proposed FLASH-CSI is a disruptive technology designed to be quickly implemented into existing, remote, or mobile production facilities for in-line sterility testing of manufactured biological products. With savings of time and cost, and utilizing minimal sample volumes, this fully sealed aseptic testing platform is expected to outperform current methods and return quantitative results within minutes. FLASH-CSI is poised to become a broadly useful analytical instrument fulfilling several DoD and market needs. Bioreactors output nucleic acid or protein products that are complex macromolecular fluids. As such, it becomes challenging to discern whether sparse contaminant entities reside within this complex background. Traditional mechanisms of detecting microbe contamination require time consuming and destructive methods with reagents, assay and plating procedures. The COVID-19 pandemic has highlighted the need for the Department of Defense (DoD) to optimize production of life-saving therapeutics and vaccines. HNu Photonics specializes in the creation, fabrication, and implementation of innovative technologies at the forefront of life science research on the International Space Station. The proposed work will harness our existing space-based technology (automated microscopy and microfluidics) and continue the research and development efforts begun in Phase I delivering optimized performance of FLASH-CSI across different uniquely identifiable contaminants. FLASH-CSI will complement DoD efforts by rapidly detecting contaminates within biological processes (antibody or vaccine production) with a non-invasive, triple redundant optical detector.