Patent ID: 6461630
Filing Date: 2002-10-08
Classification: A61L,Y10S

Abstract:
A terminally sterilized osteogenic device for implantation into a mammal produced by a method comprising the steps of:(a) providing an osteogenic device comprising an isolated, biologically active, reconbinantly produced osteogenic protein comprising a pair of disulfide bonded polypeptide chains, wherein at least one of said polypeptide chains comprises an amino acid sequence having at least six cysteine residues in the same relative positions as the six cysteine sequence (SEQ ID NO. 3)1â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ10â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ20â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ30â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ40â€ƒâ€ƒXXXXXXXXXXXXXXXXXXXXXXXXCXXXCXXXXXX â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ50â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ60â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ70â€ƒâ€ƒXXXXXXXXXXXXXXXXXXXXXXXXXCCXXXXXXX â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ80â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ90â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ100â€ƒâ€ƒXXXXXXXXXXXXXXXXXXXXXXXXCXCXâ€ƒor at least seven cysteine residues in the same relative positions as the seven cysteine sequence (SEQ ID NO. 4)1â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ10â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ20â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ30â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ40CXXXXXXXXXXXXXXXXXXXXXXXXXXXXCXXXCXXXXXX 50â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ60â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ70XXXXXXXXXXXXXXXXXXXXXXXXXCCXXXXXXX â€ƒâ€ƒâ€ƒâ€ƒâ€ƒ80â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ90â€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒâ€ƒ100XXXXXXXXXXXXXXXXXXXXXXXXCXCXâ€ƒwherein each said X is an amino acid, in combination with a biocompatible, biodegradable insoluble carrier material defining pores dimensioned to permit infiltration, proliferation, and differentiation of migratory progenitor cells when implanted into the mammal; and (b) exposing the osteogenic device of step (a) to ionizing radiation in an amount sufficient to achieve a sterility assurance factor of 10âˆ’6 thereby to produce a terminally sterilized osteogenic device competent to induce endochondral bone formation or articular cartilage formation in the mammal.