Methods for manufacturing a composition for treating bone and/or cartilage defects
First Claim
1. A method for aseptically manufacturing a mammalian recombinant collagen composition, the method comprising:
- contacting the collagen with a peptidase or protease, wherein the mammalian collagen is of non-human origin and has at least one of an osteo-inductive activity or a chondro-inductive activity, and is filter sterilized;
adding at least one scaffold material, wherein the scaffold material has osteo-conductive properties and is selected from the group of ceramic materials, biologically compatible metals, biologically compatible polymers and extracts of native bone, and mixing with the collagen;
adding at least one differentiation or growth factor having osteo-stimulative and/or chondro-stimulative activity and the scaffold; and
, co-lyophilizing the components to obtain an at least partly form-stable, spongy body, wherein the method is performed under aseptic conditions, thereby aseptically manufacturing the composition.
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Abstract
The present invention relates to compositions devices and methods for treating bone and/or cartilage defects, and a method for manufacturing such a composition or device. In a certain embodiment, the invention provides a device and/or composition for treating bone and/or cartilage defects, having at least one collagen, for example of animal origin, and further containing at least one substance having an osteo-inductive or chondro-inductive activity, at least one differentiation and/or growth factor having osteo-stimulative and/or chondro-stimulative effect, and at least one filling material, in which the composition is in the form of a lyophil.
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Citations
20 Claims
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1. A method for aseptically manufacturing a mammalian recombinant collagen composition, the method comprising:
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contacting the collagen with a peptidase or protease, wherein the mammalian collagen is of non-human origin and has at least one of an osteo-inductive activity or a chondro-inductive activity, and is filter sterilized; adding at least one scaffold material, wherein the scaffold material has osteo-conductive properties and is selected from the group of ceramic materials, biologically compatible metals, biologically compatible polymers and extracts of native bone, and mixing with the collagen; adding at least one differentiation or growth factor having osteo-stimulative and/or chondro-stimulative activity and the scaffold; and
, co-lyophilizing the components to obtain an at least partly form-stable, spongy body, wherein the method is performed under aseptic conditions, thereby aseptically manufacturing the composition. - View Dependent Claims (4, 5, 16, 17)
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2. A method for formulating a composition for treating bone and cartilage defects, the method comprising:
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concentrating a solution of recombinant human collagen, wherein the collagen is treated with acid, and is filter sterilized; mixing aseptically the recombinant human collagen with a solution of a recombinant human bone morphogenesis protein (BMP), wherein the collagen and bone morphogenesis protein are sterile or have a reduced microbial content; and granulating or co-lyophilizing aseptically the admixture to a gel, paste or a lyophil having an at least partly form-stable shape and a spongy consistency. - View Dependent Claims (3, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 18, 19, 20)
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Specification