Biomolecules in Tissue Engineered Medical Products (TEMPs): A Case Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)

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Volume 1, Issue 1 (January 2004)

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ISSN: 1546-962X
Published Online: 5 January 2004
Page Count: 21

Biomolecules in Tissue Engineered Medical Products (TEMPs): A Case Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)
Porter, TJ
Senior Scientist, Scientist and Lab Head, Department of Characterization and Analytical Development, Wyeth BioPharma, MA

Rathore, S
Senior Scientist, Scientist and Lab Head, Department of Characterization and Analytical Development, Wyeth BioPharma, MA

Rouse, J
Senior Scientist, Scientist and Lab Head, Department of Characterization and Analytical Development, Wyeth BioPharma, MA

Denton, M
Principal Scientist, Department of Biopharmaceutical Analysis, Wyeth BioPharma, MA

(Received 30 September 2002; accepted 2 April 2003)

Abstract

rhBMP-2 is an osteoinductive protein that, when administered locally, results in the induction of new bone tissue at the site of implantation. The osteoinductive properties of rhBMP-2 first were demonstrated by implantation at ectopic (nonbony) sites in rodents. BMPs are the only protein factors known to induce new, ectopic bone. rhBMP-2/Absorbable Collagen Sponge (ACS) is a TEMP that combines rhBMP-2 with a matrix for implantation. rhBMP-2/ACS is used in long bone fracture repair and spinal fusion. The development of rhBMP-2 protein as the active ingredient in the rhBMP-2/ACS product is summarized. Four aspects of rhBMP-2 development are covered: protein structural characterization, functional characterization, purity analysis and design of comparability studies to support changes in the manufacturing process. Topics discussed include rhBMP-2 as a “biologic” and as a constituent of a combination TEMP. The lessons learned during the development of rhBMP-2/ACS may allow general insight into the development of future standards for TEMPs that contain biologically active proteins.

Keywords:
recombinant bone morphogenetic protein, absorbable collagen sponge, rhBMP-2, rhBMP-2/ACS, biologic, fracture repair, osteoinductive

Paper ID: JAI11517
DOI: 10.1520/JAI11517
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Author Title Biomolecules in Tissue Engineered Medical Products (TEMPs): A Case Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Symposium Tissue Engineered Medical Products (TEMPs), 2002-11-06 Committee F04

		Home Journals STPs Manuals Topics Subscriptions/Pricing Digital Library / Journals / Journal of ASTM International (JAI) / Citation Page Volume 1, Issue 1 (January 2004) Click here to download this paper now for $25 PDF (528K) View License Agreement ISSN: 1546-962X Published Online: 5 January 2004 Page Count: 21 Biomolecules in Tissue Engineered Medical Products (TEMPs): A Case Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Porter, TJ Senior Scientist, Scientist and Lab Head, Department of Characterization and Analytical Development, Wyeth BioPharma, MA Rathore, S Senior Scientist, Scientist and Lab Head, Department of Characterization and Analytical Development, Wyeth BioPharma, MA Rouse, J Senior Scientist, Scientist and Lab Head, Department of Characterization and Analytical Development, Wyeth BioPharma, MA Denton, M Principal Scientist, Department of Biopharmaceutical Analysis, Wyeth BioPharma, MA (Received 30 September 2002; accepted 2 April 2003) Abstract rhBMP-2 is an osteoinductive protein that, when administered locally, results in the induction of new bone tissue at the site of implantation. The osteoinductive properties of rhBMP-2 first were demonstrated by implantation at ectopic (nonbony) sites in rodents. BMPs are the only protein factors known to induce new, ectopic bone. rhBMP-2/Absorbable Collagen Sponge (ACS) is a TEMP that combines rhBMP-2 with a matrix for implantation. rhBMP-2/ACS is used in long bone fracture repair and spinal fusion. The development of rhBMP-2 protein as the active ingredient in the rhBMP-2/ACS product is summarized. Four aspects of rhBMP-2 development are covered: protein structural characterization, functional characterization, purity analysis and design of comparability studies to support changes in the manufacturing process. Topics discussed include rhBMP-2 as a “biologic” and as a constituent of a combination TEMP. The lessons learned during the development of rhBMP-2/ACS may allow general insight into the development of future standards for TEMPs that contain biologically active proteins. Keywords: recombinant bone morphogenetic protein, absorbable collagen sponge, rhBMP-2, rhBMP-2/ACS, biologic, fracture repair, osteoinductive Paper ID: JAI11517 DOI: 10.1520/JAI11517 ASTM International is a member of CrossRef. Author Title Biomolecules in Tissue Engineered Medical Products (TEMPs): A Case Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Symposium Tissue Engineered Medical Products (TEMPs), 2002-11-06 Committee F04