Company
Portfolio Data
Back to Company SearchHELIOWAVE TECHNOLOGIES Inc.
UEI: F9T3KRMMEXM4
Number of Employees: 3
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2021
2
Phase I Awards
1
Phase II Awards
50%
Conversion Rate
$458,475
Phase I Dollars
$1,749,858
Phase II Dollars
$2,208,333
Total Awarded
Awards
HelioSAFE-2: A Platform for the Fast, Label-Free, Automated Evaluation of Sterility
Amount: $1,749,858 Topic: HR001120S0019-27
There is a critical need within the Department of Defense (DoD) and the medical countermeasure (MCM) development community to rapidly manufacture biologics such as nucleic acid products and proteins (e.g., antigens, monoclonal antibodies) in varying quantities (gram to kg scales). These products can be used both as MCM and for other industrial processes such as enzyme-catalyzed reactions. Importantly, sterility testing is performed on MCMs to confirm that they are contaminant-free. Sterility testing is typically performed by taking a percentage of the total reagent or cellular inputs as well as the products to be tested in each manufactured batch. There are several limitations to current sterility testing methods, which are time-consuming and costly Therefore, a method that can provide rapid, small sample volume, fully automated, small footprint, low power requirements, and in-line sterility testing would constitute an ideal solution to overcome critical bottlenecks. Toward this end, HelioWave Technologies, LLC, proposes to advance the development of its HelioSAFETM system for rapid, label free automated sterility testing. This effort will involve validating the performance of the system using a panel of biological contaminants, including bacterial cells, bacterial spores, and fungi. In addition, the system will be tested using a variety of sample types derived from nucleic acid and protein therapeutic and medical countermeasure (MCM) workflows. In addition, the project will advance the development of the HelioSAFETM system toward FDA qualification and finalize the performance characterization of the device and detection hardware for scale-up manufacturing. Finally, Finally, we will subject the HelioSAFETM system to independent verification and validation testing to ensure it meets performance expectations. Taken together, these activities will deliver novel, rapid, and low-cost sterility testing that will positively impact biopharmaceutical manufacturing workflows.
Tagged as:
SBIR
Phase II
2022
DOD
DARPA
HelioQUANT: A Platform for Fast, Label-Free, Automated Evaluation of Bioburden
Amount: $233,475 Topic: NIAID
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.
Tagged as:
SBIR
Phase I
2022
HHS
NIH
HelioSAFE: a platform for the fast, label-free, automated evaluation of sterility
Amount: $225,000 Topic: HR001120S0019-27
The overarching technical objective of this proposal is to develop, prototype, and validate the HelioSAFETM sterility testing platform (Helio Sterility Assessment using Fluidics Enabled technology). To achieve this goal, we will pursue the following three Technical Objectives: Technical Objective 1. To develop and test the HelioSAFETM Cultivation Chip (HCC)TM, a novel microfluidic device that can rapidly concentrate microbial contaminants with minimum loss, incubate concentrated sample material in diverse culture media formulations, followed by rapid single-cell-resolution cell counting (before and after cultivation), to accurately and rapidly determine whether a sample contains viable microorganisms. Bacillus subtilis subsp. Spizizenii will be used as a model organism throughout this development process. Technical Objective 2. To expand HCC testing to other microorganisms and fully validate the performance of the HelioSAFETM system. We will expand the testing to Clostridium sporogenes, an anaerobe, to further validate the utility of HelioSAFETM. We will also finalize the performance characterization of the HCC and fix the design parameters towards future scale-up manufacturing. Technical Objective 3. To further develop the HelioSAFETM system as an in-line monitoring system. We will use sterile tubing to connect the HelioSAFETM chip to a simulated sterile biopharmaceutical production line and conduct periodic sampling and testing of the solution for microbial contaminants. This effort will demonstrate the feasibility of HelioSAFETM as an in-line sterility monitoring tool. The outcome of our pursuit of these objectives will be the development of a fully validated prototype HelioSAFETM sterility testing chip, determination of the performance of the HelioSAFETM system, demonstration of the feasibility of HelioSAFETM as an in-line fully automated sterility monitoring system, and identification of technical strengths and limitations (if any). In the future (e.g., Phase 2), we will optimize the HelioSAFETM HCC design with scale-up manufacturing in mind, demonstrate the feasibility of small-volume analysis on the chip, and develop the HCC chip reader (that includes a compact single-frequency impedance analyzer, compact OEM syringe pump, and pneumatic valve controller). In parallel, we will also test the following microbes from the DARPA BAA list as model microbial contaminants to further define the performance of the HelioSAFETM system: Candida albicans; Pseudomonas aeruginosa; Aspergillus brasiliensis; Staphylococcus aureus; and Bacillus subtilis subsp. spizizenii (spores).
Tagged as:
SBIR
Phase I
2021
DOD
DARPA