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AssigneeStryker Corporation
InventorNiles Ron
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Disclosed herein are heretofore undescribed preparations of highly concentrated, solubilized proteins, such as but not limited to, Bone Morphogenetic Proteins. Such protein preparations can be formulated in an aqueous carrier at protein concentrations in excess of 10 mg/ml when using the methods of manufacture taught herein. Such methods yield stable protein preparations in either solubilized or lyophilized form. The protein preparations of the present invention are particularly beneficial when administered either locally or systemically, in part, because low administration volumes can be accomplished. This is especially important for local treatment of certain anatomic locations such as, for example, the synovial fluid of a joint when treating osteoarthritis with BMP-7 or the intradiscal space when treating degenerative disc disease with BMP-7.
A preparation of bone morphogenetic protein comprising:
A kit comprising a lyophilized bone morphogenetic protein and a reconstitution diluent, wherein the protein and the diluent are in separate containers, and wherein the amount of diluent is sufficient only for preparation of solubilized protein at a concentration of at least about 10 mg/ml.
A method for manufacturing a concentrated form of lyophilized recombinant bone morphogenetic protein, the method comprising the steps of:
A kit for the treatment of a disorder, injury or disease comprising a lyophilized bone morphogenetic protein and a reconstitution diluent, wherein the protein and the diluent are in separate containers, and further wherein the kit comprises a plurality of separate containers each containing an amount of diluent, such that the amounts of diluent are sufficient to prepare solubilized protein preparations ranging in concentration from at least about 2 mg/ml to about 60 mg/ml for use in the treatment of a disorder, injury or disease.
A method for preparing a concentrated form of bone morphogenetic protein, the method comprising the steps of:
A method for preparing a concentrated form of protein in lyophilized or other reconstitutible non-liquid form, the method comprising the steps of:
Dependencies are inferred from the claim text.