Development of 3D Human Blood Brain Barrier Formation Assay

The Food and Drug Administration (FDA) intends to award a Sole Source Firm Fixed Price Purchase order to develop an in-vitro blood-brain barrier formation and integrity new approach method (NAM) for the evaluation of potential developmental neurotoxicity hazard. The purpose of this acquisition is to develop an in-vitro blood-brain barrier formation and integrity model for the evaluation of potential developmental neurotoxicity hazard of foods and dietary supplements. The scope of this work encompasses the optimization of human-derived brain microvascular endothelial cells, neurons, and astrocytes for a multi-chip microfluidic plate format assay, selection of appropriate in-plate assay control chemicals for each assay endpoint, and evaluation of four performance compounds with expected activity in those endpoints. Key tasks and requirements include: • Optimization of human-derived brain microvascular endothelial cells, neurons, and astrocytes • Selection of in-plate assay control chemicals • Evaluation of four performance compounds • Development of a multi-chip microfluidic plate format assay • Provision of raw experimental data for all in-plate assay control chemicals and performance compounds