Tissue biomaterials are used in a variety of medical devices including cardiac valves, vascular grafts, surgical patches and supports and various skin substitutes. This Phase I research proposes methods for the production and characterization of a primary reference material (PRM) using bovine pericardium as a starting material. The program involves the production of small batches of pericardial PRM followed by preliminary characterization of the bulk and surface properties to assess the feasibility of using pericardium as a tissue PRM. This work will result in the first tissue biomaterial to be commercially available outside the clinical setting. The pericardial PRM will be commercialized as a standard for calibration of physicochemical and biological tests. The fabrication of PRM will provide a source of well characterized, stable, tissue-based material to biomaterials investigators and medical device developers.
