초록 ▼

Disclosed are terminally sterilized osteogenic devices for implantation into a mammal. The devices contain a combination of a biologically active osteogenic protein and an insoluble carrier which after being combined are sterilized by exposure to ionizing radiation, for example, by exposure to gamma

Disclosed are terminally sterilized osteogenic devices for implantation into a mammal. The devices contain a combination of a biologically active osteogenic protein and an insoluble carrier which after being combined are sterilized by exposure to ionizing radiation, for example, by exposure to gamma rays or an electron beam. The terminally sterilized devices of the invention are characterized in that they induce bone formation following implantation into a mammal. Also disclosed is a method for inducing bone formation in a mammal by implanting a terminally sterilized device of the invention into a preselected locus in a mammal. Also disclosed is a method for preparing the terminally sterilized device of the invention.

대표청구항 ▼

1. 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,

1. 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)1 10 20 30 40 XXXXXXXXXXXXXXXXXXXXXXXXCXXXCXXXXXX 50 60 70 XXXXXXXXXXXXXXXXXXXXXXXXXCCXXXXXXX 80 90 100 XXXXXXXXXXXXXXXXXXXXXXXXCXCX or at least seven cysteine residues in the same relative positions as the seven cysteine sequence (SEQ ID NO. 4)1 10 20 30 40CXXXXXXXXXXXXXXXXXXXXXXXXXXXXCXXXCXXXXXX 50 60 70XXXXXXXXXXXXXXXXXXXXXXXXXCCXXXXXXX 80 90 100XXXXXXXXXXXXXXXXXXXXXXXXCXCX wherein 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 10-6 thereby to produce a terminally sterilized osteogenic device competent to induce endochondral bone formation or articular cartilage formation in the mammal.