SBIR Phase II:A high throughput microfluidic platform to accelerate biomanufacturing transitions in biologics development

The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase II project is accelerating the manufacturing of and access to newly developed therapeutics and vaccines. To address global health problems, effective and safe new biologics such as therapeutics and vaccines will need to be manufactured at unprecedented large scales and short times. Accelerating access to new biologics for potentially billions of individuals will be critical for healthcare and the global economy. The solutions will be manifold, and realizing productive and robust manufacturing for these candidate preventative and therapeutic medicines in a short period of time remains a key challenge to transition discoveries from the lab to the clinic. The innovations proposed in this project could significantly accelerate drug development and biologics manufacturing by shortening the biologics development times up to six months. Vaccine and drug developers would succeed faster and fail faster, enabling accelerated transitions of discoveries for new therapeutics to the clinic and beyond by addressing critical steps in manufacturing. Improving transitions should also let developers test a higher number of compounds, thereby increasing the performance and potentially reducing the side effects of these drugs._x000D_ _x000D_ This project aids in the manufacturing of novel therapeutics and vaccines. Manufacturing of biologics starts with a high-performing clonal cell-line, derived (by definition) from a single cell. Developing such a cell line today takes up to six months due to the iterative screening and testing needed to assure quality and performance. This essential step in any biologic manufacturing transition is critical time lost in the fight against disease. This project enables drug developers to select a high-performing cell clone in one day, compared to many months by using a proprietary, single-cell, proteomics platform at an unprecedented throughput rather than having to go through lengthy, iterative selection, clonal expansion and analytics. The scope of the research is focused on addressing the remaining critical technical hurdles before deploying the technology for commercial use. Specifically, a systematic and statistical approach will be used to implement necessary alternative materials and processes. The goal of the project will be implementing the developed processes with biotechnology industry partners to accelerate vaccine and therapeutic development and manufacturing._x000D_ _x000D_ This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.