DEVELOPMENT OF CELL-PERMEABLE FLUORESCENT PROBES AS PROCESS-ANALYTICAL TOOLS FOR QUALITY CONTROL OF STEM CELL BIOPROCESSES

Abstract

Mesenchymal stromal cell (MSC) therapy represents a growing therapeutic and commercial value proposition, owing to their paracrine effects, immmunomodulatory properties, and regenerative potential. Developing bioassays of MSC potency that inform biological traits relevant for therapeutic strategy are critical. Further, a shift from planar (culture flasks) to scalar technologies (controlled bioreactors) is increasingly appreciated to ensure functional consistency between product lots, in addition to better process control.