This startup develops a microfluidic-based analytical platform for sterility testing in biopharmaceutical manufacturing. Their system integrates fluid manipulation controls, hardware, software, and consumable chips to provide rapid, cost-effective contamination analysis of materials and products.
Funding
Funding not disclosed
Founders
Product
Problem
Traditional sterility and bioburden testing methods in biopharmaceutical manufacturing are slow, often requiring up to 14 days for results, which delays product release and increases the risk of contamination events. Existing methods also often rely on manual processes, lack the sensitivity to detect low levels of contamination, and are not easily integrated into modern, automated manufacturing workflows.
Solution
HelioWave Technologies provides a microfluidic-based analytical platform, HelioSAFE TM, that enables rapid, automated sterility and bioburden testing for biopharmaceutical manufacturing. The system combines microfluidic chips, fluid manipulation hardware, and software to deliver contamination analysis in approximately 30 minutes, a significant reduction from traditional methods. HelioSAFE TM employs a label-free, non-destructive analytical method that identifies microbes based on their unique electrical response signatures, offering single-cell resolution for highly sensitive contaminant detection. The platform is designed to meet USP <71> standards and can be used for off-site, on-site at-line, and real-time monitoring.
Target Audience
HelioWave's primary customers are pharmaceutical companies, biomanufacturing facilities, and government agencies seeking to enhance the safety and quality control of drugs and food products.
Features
- Rapid sterility testing with results available in approximately 30 minutes
- Microfluidic-based system integrating fluid manipulation, hardware, and software
- Label-free, non-destructive microbial detection based on electrical response signatures
- Single-cell resolution for detecting contaminants at low concentrations
- Compatibility with a wide range of microorganisms, including bacteria, fungi, and endospores
- Designed to meet USP <71> regulatory guidelines
- Customizable platforms and flexible detection modalities tailored to specific biomanufacturing processes
- Potential for integration into automated workflows and continuous manufacturing environments