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Brochures Australian Biotechnologies

Osteoinductive Statement:

  • Demineralized bone allografts must be carefully processed to retain their biological potential.
  • Allovance® Osteoinductive grafts are only released after each batch is able to successfully demonstrate the osteoinductivity of the material using the ‘gold standard’ in vivo model through an independent, TGA licensed facility1-4.
  • Allovance® Osteoinductive grafts are backed by real time stability studies demonstrating the osteoinductivity of the grafts is retained for the whole shelf life, as per TGA requirements5-6

References:

  1. Urist MR. Bone: formation by autoinduction. Science 1965;150(3698):893–9.
  2. Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular products, V1.0, April 2013
  3. ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteo-inductive Potential
  4. Katz JM, Nataraj C, Jaw R, Deigl E, Bursac P. Demineralized bone matrix as an osteoinductive biomaterial and in vitro predictors of its biological potential. J Biomed Mater Res B Appl Biomater 2009;89(1):127–34.
  5. L. Shimp, “Heat resistance of allograft tissue,” Cell Tissue Bank., vol. 9, no. 4, pp. 259–266, Dec. 2008.
  6. Internal Report Data on file – (V1726)

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