PHI OPTICS INC — Department of Health and Human Services SBIR Phase II: 400

Description

Project Summary/Abstract Viable cell concentration is one of the most important key performance indicator during upstream technologies in mammalian cell culture. Customer Discovery discussions with biopharma execs and RandD specialists revealed there is an unmet need for on-line/in-line monitoring of cell viability in pharma bioreactors driven by compliance with real-time product quality assurance as described in Process Analytical Technology (PAT) and Quality by Design initiatives. Preliminary work equivalent to Phase I effort has resulted in a cell imaging system including a flow cell setup that simulates an on-line stirring bioreactor sampling route. Proof-of-concept was also established for detection and classification of live/dead assays using digital staining via PICS (Phase Imaging with Computational Specificity). This Small Business Innovation Research project proposes to build a commercial prototype instrument for real time, quantitative and high-throughput cell viability scoring for on-line/in-line bioreactor monitoring that meets the metrics of interest for pharma RandD applications. During this effort the standard operation of the QPI+PICS instrument will be refined and the automated software detection and classification of live/dead assays will be completed. At the end of this Direct Phase II project we will deliver a commercial prototype -a “push-of-a-button” viability scanner with the above capabilities built in.