Biocompatibility of the Bioelastic Materials, Poly(GVGVP) and Its γ-Irradiation Cross-Linked Matrix: Summary of Generic Biological Test Results

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Abstract
The complete series of the recommended generic biological tests for materials and devices in contact with tissues and tissue fluids and blood have been carried out by an independent testing laboratory on the elastic protein-based (bioelastic) polymer, Poly(L-Val1-L-Pro2-Gly3-L-Val 4-Gly5) with a degree of polymerization greater than 120, and its 20 Mrad γ-irradiation cross linked elastic matrix, X20-poly(VPGVG). The specific tests and the summarized results given in parentheses are: (1) the Ames mutagenicity test (non- mutagenic), (2) cytotoxicity-agarose overlay (non-toxic), (3) acute systemic tox icity (non-toxic), (4) intracutaneous toxicity (non-toxic), (5) muscle implantation (favorable), (6) acute intraperitoneal toxicity (non-toxic), (7) systemic antigenic ity (non-antigenic), (8) dermal sensitization—the Magnusson and Kligman maximization method (non-sensitizing), (9) pyrogenicity (non-pyrogenic), (10) Lee White clotting study (normal clotting time), and (11) in vitro hemolysis test (non-hemolytic). Thus, this new elastomeric polypeptide biomaterial which is based on the most striking repeating sequence in the mammalian elastic fiber exhibits an extraordinary biocompatibility. This parent bioelastic material and a wide range of component peptide variations are under development for an equally wide range of potential medical applications such as prevention of adhesions, drug delivery, and synthetic arteries.