HR001121C0178

Small Business Innovation Research Program (SBIR) Phase I

HelioSAFE: a platform for the fast, label-free, automated evaluation of sterility

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).

The goal of phase I is to establish the technical merit, feasibility, and commercial potential of proposed R&D efforts and determine the quality of performance of the small business awardee organization.

HR001120S0019-27

D20I-27-0349

HR001120S0019.I

Adrian Guzman