HelioQUANT: A Platform for Fast, Label-Free, Automated Evaluation of Bioburden

Abstract Bioburden constitutes a key component of environmental monitoring programs in biomanufacturing facilities, where routine testing allows manufacturers to assess the efficiency of the cleaning and decontamination of pack- aging, product components, and worksurfaces. HelioWave Technologies, LLC, is dedicated to revolutionizing bioburden testing by developing products that dramatically increase the speed, efficiency, and usability, while lowering the cost of bioburden testing for materials and products used in the biomedical industry. The underlying approach used for bioburden testing—the assessment of microbial growth on solid media-- has remained un- changed for a century. HelioWave Technologies, LLC, is developing HelioQUANTTM, a novel bioburden testing technology platform that will replace outdated methods by combining advances in two broad technological areas, droplet microfluidics and impedance detection, to deliver a compelling bioburden testing solution. Droplet micro- fluidics systems use pico-liter-volume water-in-oil emulsion droplets that function as cell-encapsulated bioreac- tors for the performance of low cost, rapid, single-cell-resolution biological assays. Impedance spectroscopy- based cell detection is label-free, can detect broad ranges of microorganisms, at high speed. Over the past decade, the company’s academic partners have substantially advanced the basic science and engineering that supports the development of a system that integrates innovations in droplet microfluidics and impedance micros- copy for bioburden testing. The proposed HelioQUANTTM system, which leverages this expertise and innova- tions, will deliver dramatic reductions in cost and testing times, respectively, for bioburden evaluation. With these ideas in mind, the overarching technical objective of this proposal is to prototype the HelioQUANTTM bioburden testing platform. To achieve this goal, two Specific Aims will be pursued: (1). To advance the development of the droplet microfluidic module (HQ-DMMTM) of the HelioQUANTTM system; (2) To advance the development of the impedance detection module (HQ-IDMTM) of the HelioQUANTTM system. The outcome of the proposed work will be the development of the HelioQUANTTM prototype for bioburden assessment. The proposed work will also identify technical strengths and limitations (if any) of the proposed integrated system, and thereby set the stage for developing a “manufacture ready” integrated HelioQUANTTM product in Phase II of the NIH SBIR program.