Dibotermin alfa; Recombinant human bone morphogenetic protein-2 (rhBMP-2)

Specification

• Cat#: THP-0030
• Product Name: Dibotermin alfa; Recombinant human bone morphogenetic protein-2 (rhBMP-2)
• Description: The product is a recombinant human bone morphogenetic protein-2 (rhBMP-2) derived from a recombinant Chinese Hamster Ovary (CHO) cell line. rhBMP is a disulfide-linked dimeric protein molecule with two major subunit species of 114 and 131 amino acids. Each subunit is glycosylated with high-mannose-type glycans.
• Sequences: Not Available
• Species: Human
• Molecular Weight: Not Available
• Source: CHO
• Purity: >99% by SDS-Page and HPLC analysis
• Cas No: 246539-15-1
• Formula: Not Available
• Endotoxin Level: <0.001 EU per 1 μg of the peptide by the LAL method
• Biological Activity: 1.5 mg/ml

Pharmaceutical Information

• Pharmaceutical Application: Dibotermin alfa
• Applications: indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.indicated for single-level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
• Examples of Clinical Use: Acute tibia fractures
• Pharmacodynamics: The product promotes bone and cartilage formation through anabolic effects in human osteoblastic cells. Radiographic, biomechanical and histologic evaluation of the induced bone at the site of implantation supports that induced bone from the product therapy is capable of biological and biochemical function as native bone and repair abilities.
• Mechanism of action: In the same pathway shared by endogenous BMPs, recombinant human BMP-2 (rhBMP-2) binds and initiates intracellular signal cascade through an oligomeric transmembrane receptor complex formed by type I and II serine/threonine kinase receptor proteins. These BMP receptors are expressed on the surface of mesenchymal cells and upon binding of BMP-2 to the BMP receptor type II, type II receptor phosphorylates and activates type I receptor. Type I receptor may also undergo autophosphorylation. Activated BMP type I receptor then phosphorylates intracellular effector proteins, the receptor-regulated Smads (R-Smads). Smad1, Smad 5 and Smad 8 associate with the Co-Smad, Smad4 and once activated via complex formation, they translocate to the nucleus where they associate with other transcription factors and bind promoters of target genes to control their expression. This ultimately results in bone formation at the site of implantation. Dibotermin alfa causes mesenchymal cells to differentiate into cartilage- and bone-forming cells. Implantation of dibotermin alfa in trabecular bone results in transient resorption of the bone surrounding the implant, followed by replacement of degraded matrix by newly differentiated cells.
• Affected organisms: Not Available
• Targets: Target 1. Bone morphogenetic protein receptor type-2; Target 2. Bone morphogenetic protein receptor type-1A