STTR Phase II: A Plasmonic Nanopore Sensor Device to Quantify DNA Loading Efficiency of Single Adeno-associated Virus (AAV) Particles

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is based on innovations in sensor technology used during biomanufacturing. The proposed sensor has the potential to outperform existing analytical techniques by capturing multiple data types per gene-carrying particle to enable complete characterization. The sensor output will inform the manufacturer how many of these particles are empty or incompletely loaded. This information is critical because empty or incompletely loaded particles can cause serious adverse effects. Importantly, this sensor technology will be developed for use in early steps of the biomanufacturing process. The outcome of this project will be a portable sensor box that will be then shipped to manufacturers for on-site testing. This Small Business Technology Transfer (STTR) Phase II project will demonstrate a nanoscale sensor device that utilizes optical and electrical signals The sensor technology developed in this project will allow AAV producers to optimize formulation quality early in the manufacturing process. Furthermore, early optimization will offer significant cost savings as it will avoid scaling up the wrong formulation. The core technology was de-risked during the Phase I award. The focus of this Phase II project will be to (1) integrate the sensor components along with an on-chip AAV filter technology into a table-top size device, (2) further develop signal denoising, feature extraction and classification using artificial intelligence to automate analysis and data presentation, and (3) collaborate with AAV-producing manufacturers for user feedback and customer development. 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.