PFI: AIR-TT: PharmaFlux: Drug Evaluation on a Biomimetic Microfluidic Device

Lehigh University, Bethlehem PA

Investigators

Abstract

This PFI: AIR Technology Translation project focuses on translating a therapeutic analysis platform designed to mitigate scientific, financial, and temporal risks associated with transitioning new therapeutics from high-throughput evaluations to later stages of testing. The therapeutic analysis platform is important because it will serve to assist pharmaceutical companies in the efforts of bringing viable new therapeutics to market in a more timely, cost effective, and sustainable manner. Bringing this technology to market will in turn provide benefits to pharmaceutical companies developing new therapeutics and the patients whom ultimately receive treatment. The project will validate current proof-of-concept testing with the therapeutic analysis platform, which will be carried out using current therapeutic systems produced by pharmaceutical and biotechnology companies. This platform has the following unique features: capability of controllable flow, small sample volume requirements, scalable, flexible design layout, ability to mimic specific disease conditions, and ease of use/data collection. These features enable advantages of reduced operating costs, high-throughput testing capabilities providing greater efficiency of new therapeutic development, reduced risk associated with large investments of time and funding, and greater follow-through to market for new therapeutics when compared to the leading competing statically-grown cell-based analysis platforms in this market space today.   This project addresses the following technology gaps as it translates from research discovery toward commercial application. Baseline testing of the platform has been completed on a few therapeutic delivery systems such as nanoparticles. The next steps in validation of the analysis platform is the application of the technology to well-established therapeutic systems currently utilized in the pharmaceutical industry. As such, various stages of benchmark testing will be performed with the goal of characterizing therapeutic candidate delivery (cell binding and interactions), disease state efficacy markers, and cell-based toxicity at various shear rates. Utilization of the analysis platform will provide data which can then be directly or indirectly compared to current industry standards and published data sets for validation of the platform. In addition, graduate and undergraduate students involved in this project will receive research, commercialization and entrepreneurship experiences through literature reviews, lab-based research, product design, and strategic planning with pharmaceutical and biotechnology company partners. The project currently engages a local Bethlehem, PA company, Particle Sciences, a part of Lubrizol Life Sciences, to assist in the characterization of novel therapeutic delivery vehicles prior to later stage in vivo testing to ensure that full optimization is achieved. Additional industry based collaborators will be acquired throughout future testing as a part of this technology translation effort from research discovery toward commercial reality.