Journal Published Online: 05 January 2004
Volume 1, Issue 1

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

CODEN: JAIOAD

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
Department of Characterization and Analytical Development, Wyeth BioPharma, Andover, MA
Rathore, S
Department of Characterization and Analytical Development, Wyeth BioPharma, Andover, MA
Rouse, J
Department of Characterization and Analytical Development, Wyeth BioPharma, Andover, MA
Denton, M
Department of Biopharmaceutical Analysis, Wyeth BioPharma, Andover, MA
Pages: 21
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Stock #: JAI11517
ISSN: 1546-962X
DOI: 10.1520/JAI11517