All injectable medicines must be proven sterile before delivery to patients. However, sterility testing, which uses approaches that have remain unchanged for more than a century, constitutes a major bottleneck in biopharmaceutical manufacturing pipelines. These methods require long cultivation times (weeks), large test volumes, and lack real-time monitoring capabilities. Thus there is a significant unmet need to reduce the overall cost and time required to conduct sterility testing.

HelioWave Technologies LLC is an early-stage start-up company dedicated to revolutionizing sterility testing by developing microfluidics-driven products that dramatically increase the speed (~ 50-fold), efficiency, and usability, while lowering the cost (~10-fold) of sterility testing of materials and products used in biopharmaceutical manufacturing processes. Utilizing innovative microfluidic-based technology, the company is positioned to replace conventional sterility testing methods with low cost real-time monitoring systems that can be directly integrated into current biopharmaceutical production workflows without modification or disruption.