Volume 1, Issue 1 (January 2004)

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

    (Received 30 September 2002; accepted 2 April 2003)

    Published Online: 2004

    CODEN: JAIOAD

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    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.


    Author Information:

    Porter, TJ
    Senior Scientist, Scientist and Lab Head, Department of Characterization and Analytical Development, Wyeth BioPharma, Andover, MA

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

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

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


    Stock #: JAI11517

    ISSN: 1546-962X

    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