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Bioreactors and Reparative Medicine


Wednesday, October 14, 2015


Major obstacles to the generation of functional tissues and their widespread use are limited by rudimentary tissue growth technologies. The purpose of this funding opportunity is to encourage small businesses to develop sophisticated and complex biomimetic culture systems that are capable of precise control of the cellular and 3-dimensional organ microenvironment, and which address the unique physiological dynamics of heart, lung and blood tissues.  Projects awarded under this announcement should show evidence of developing or using good laboratory practice (GLP) standards and/or good manufacturing practices (GMP) standards, which play an important role in the adoption of many technologies used for pre-clinical research.  Additionally, sources of cell variability should be discussed in the context of potential elements of measurement assurance and use of reference materials.  For projects proposing clinical grade bioreactors and clinical investigations, an applicant must provide evidence that they have contacted the Food and Drug Administration (FDA) for guidance concerning the development of their bioreactor device, such as correspondence regarding Investigational New Drug (IND) Application and status of their project in a timeline related to Federal regulatory approval processes.

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