The CellRaft AIR System Workflow Automation for Stem Cell Isolation and Recovery

DESCRIPTION provided by applicant Stem cell research is an emerging field with the promise of creating dramatic new approaches for disease treatment and drug discovery The research and regenerative medicine market space for stem cells is one of the most dynamic areas in the life science industry today Globally the stem cell market is growing at a CAGR of and will reach an approximate value of US$ billion by and technological advancement is believed to be one of the key factors that will drive growth in this field Cell Microsystems is North Carolina based start up biotechnology company whose mission is to commercialize a novel yet affordable platform for the efficient isolation of viable single cellsor colonies from a mixed population without the need for release from the culture substrate an often times detrimental procedure to the cell The companyandapos s andquot CellRaftandquot formerly IsoRaft technology is based on a unique cell array developed by the Allbritton Laboratory at the University of North Carolina UNC at Chapel Hill The core technology comprises a disposable microarray the CellRaft Array for culturing cells and a simple manually operated instrument for isolating the cell colony of interest While a number of commercially available technologies claim capabilities toward identifying and selecting specific cells such as stem cells limitations remain including cost a need for large sample sizes collection via cell damaging detachment from the culture surface and restrictive criteria for identifying cells of interest In contrast the CellRaft technology represents a rapid user friendly and affordable cell isolation system Phase I efforts focused on tailoring theCellRaft tm System for stem cell research A range of materials were evaluated for incorporation into the CellRaft resulting in a consumable with optimized flexibility culture compatibility surface roughness and geometry concavity Methods were also standardized for the tracking and collection of single CellRafts Finally intestinal epithelial stem cells IESCs were seeded on CellRafts with novel correlations observed between gene expression and morphology of single cell derived IESC enteroids These data recently published in Nature Cell Biology provide strong proof of concept that stem cell niche biology can be replicated and studied with the CellRaft System To expand these studies and initiate commercialization of this powerful system Phase II will focus on development of an Automated Isolation and Recovery AIR System comprising an instrument with appropriate optics and sample handling capabilities automated signal analysis software and commercial scale manufacturing of the CellRaft consumable the CellRaft Array Prototype systems will then be validated internally by Cell Microsystems as well as by external collaborators with various interests in stem cell biology applications PUBLIC HEALTH RELEVANCE Understanding stem cell biology requires the isolation and molecular analysis of individual cells with ensemble responses of many cells often masking variations in critical differentiation pathways Cell Microsystems and its founder Dr Nancy Allbritton have pioneered an innovative single cell isolation technology commercially marketed as the CellRaft System During this Phase II proposal we will expand on this technology developing prototypes of the CellRaft AIR System providing an unparalleled degree of workflow automation for single cell isolation Prior to being made broadly available through Cell Microsystemsandapos Early Adopter Program the prototype system will be prepared for commercial scale manufacturing tested for preliminary premarket safety and externally validated in two University of North Carolina stem cell laboratories