DEFINITION

Construct Human Fibroblasts in Polyglactin Scaffold is a living monolayer skin substitute derived from neonatal foreskins. It is composed of fibroblasts, an extracellular matrix, and a bioabsorbable scaffold. Human fibroblasts are seeded onto a bioabsorbable, nonantigenic and nonpyrogenic mesh scaffold composed of polyglactin, a copolymer of glycolide and lactide. The fibroblast-cell banks, from which Construct Human Fibroblasts in Polyglactin Scaffold are derived have passed applicable donor eligibility requirements for relevant communicable diseases. Maternal blood sera are tested for evidence of infection with human immunodeficiency virus types 1 and 2, hepatitis B and C viruses, syphilis, and human T-lymphotropic virus type 1 and are found negative for the purpose of donor selection. Construct Human Fibroblasts in Polyglactin Scaffold is manufactured with sterile components under aseptic conditions within the final package. Reagents used in the manufacture of Construct Human Fibroblasts in Polyglactin Scaffold are tested and found free of viruses, retroviruses, endotoxins, and mycoplasma before use. All materials derived from bovine sources originate from countries free of bovine spongiform encephalopathy. During subsequent screening of the fibroblast cell strain at various stages in the manufacturing process, testing for these same viruses, as well as Epstein-Barr virus and human T-lymphotropic virus type 2, is carried out and found to be negative. The final product is inspected and tested to ensure that the product meets specifications.