Synopsis of the Food and Drug Administration–National Institute of Standards and Technology Co-Sponsored “In Vitro Analyses of Cell/Scaffold Products” Workshop

Complex, dynamic mixtures of cells and structural components, known as cell/scaffold products, are in development as therapeutics for the repair, replacement, and regeneration of a wide variety of tissues damaged by acute, chronic, degenerative, or congenital diseases. These types of tissue-engineered products hold the potential to treat many diseases and injuries that currently do not have effective treatments. Cell/scaffold products are manufactured using complex regimens of cell expansion, materials processing, and cell-biomaterial integration. A critical step toward commercial availability of cell/scaffold-based therapeutics is the establishment of methods to produce a product that can be manufactured in a consistent and reliable manner. To effectively treat patients' needs, manufacturing processes must be designed to achieve desired, pre-defined product criteria and characteristics. Product inconsistency may also contribute to clinical studies yielding ambiguous data and hinder market approval by the Food and Drug Administration (FDA).