Research Project: Effects of Manufacturing Processes on Chondrocyte Phenotype and Adhesion for the Production of Tissue Engineered Medical Products
Tissue engineered medical products (TEMPs) are complex products that are composed of combinations of cells, soluble factors and material scaffolds. TEMPs are an attractive alternative for cartilage repair. However, a major obstacle in chondrocyte-based TEMPs is the limited availability of cells that maintain their original phenotype when cultured as a single layer in 2-dimensions (monolayer). This project is motivated by a need for standardized methods that define the chondrocyte phenotype using both biological (i.e., gene and protein expression) and physical (i.e., cell attachment strength) assessment following variations in manufacturing process conditions. The development of new assays that can measure specific and early biological and mechanical changes in complex device and cellular products is of critical importance for the Agency to aid the review process. The test methods developed as a result of this project are incorporated into ASTM and ISO consensus standards.