Bioburden constitutes a key component of environmental monitoring programs in bio manufacturing facilities, where routine testing allows manufacturers to assess the efficiency of the cleaning and decontamination of pack-aging, product components, and work surfaces. 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Technologies, LLC, is developing HelioQUANTTM, a novel bioburden testing technology platform that will replace outdated methods by combining advances in two broad technological areas, droplet microfluidics and impedance detection, to deliver a compelling bioburden testing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 bioreactors 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 innovations, 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 alsoidentify 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.
Public Health Relevance Statement: Narrative Regulations require that the burden of microbes associated with manufactured non-sterile medical devices and products fall below defined thresholds. Therefore, bioburden testing is a routinely performed by manufacturing facilities where such products are made. HelioWave Technologies, LLC, is dedicated to revolutionizing bio burden testing by developing products that dramatically increase the speed, efficiency, and usability of bioburden testing systems, and thereby adding substantial value to biomedical product manufacturing.
Project Terms: Biological Assay, Assay, Bioassay, Biologic Assays, Biotechnology, Biotech, Cell Survival, Cell Viability, Cells, Cell Body, Culture Media, growth media, Decontamination, Electrodes, Emulsions, Engineering, Environmental Monitoring, Ecologic Monitoring, Ecological Monitoring, environmental testing, Escherichia coli, E coli, E. coli, Future, Goals, Growth, Generalized Growth, Tissue Growth, ontogeny, Industry, Materials Testing, Medical Device, Methods, Microscopy, NIH, National Institutes of Health, United States National Institutes of Health, Oils, living system, Organism, P aeruginosa, P. aeruginosa, Pseudomonas pyocyanea, Pseudomonas aeruginosa, Quality Control, Salmonella, Spectroscopy, Spectrum Analyses, Spectrum Analysis, S aureus, S. aureus, Staph aureus, Staphylococcus aureus, Technology, Testing, Time, Water, Hydrogen Oxide, Work, falls, electric impedance, Electrical Impedance, Impedance, base, Label, Procedures, Area, Solid, Encapsulated, Specific qualifier value, Specified, Phase, Medical, Evaluation, fluid, liquid, Liquid substance, tool, microbioreactor, Bioreactors, programs, microorganism, System, Performance, Animal Models and Related Studies, model of animal, model organism, Animal Model, microbial, Speed, Structure, novel, Basic Research, Basic Science, Regulation, Sampling, portability, Manufacturer Name, Manufacturer, Pharmaceutical Agent, Pharmaceuticals, Pharmacological Substance, Pharmacologic Substance, µfluidic, Microfluidics, Incubated, Microfluidic Device, Microfluidic Lab-On-A-Chip, microfluidic chip, Microfluidic Microchips, Detection, Resolution, Small Business Innovation Research Grant, SBIR, Small Business Innovation Research, Monitor, Process, Development, developmental, cost, digital, Advanced Development, design, designing, Outcome, manufacturing facility, Mind, innovation, innovate, innovative, Microbe, Biomanufacturing, usability, prototype, professional atmosphere, job environment, work atmosphere, work environment, workplace climate, workplace environment, Formulation
