Cell and Tissue Banking

, Volume 6, Issue 1, pp 3–12 | Cite as

A review of osteoinductive testing methods and sterilization processes for demineralized bone

  • Julie Glowacki
Review Article


Allogeneic demineralized bone has been used extensively as a clinical graft material because it has osteoinductive and osteoconductive properties. Concerns over processing and terminal sterilization procedures that may reduce performance have led clinicians to call for assurances of product potency. There is extensive experience on effects of demineralized bone in animal and cell culture models with the possibility for future evidence-based standards for release of products. Evaluation of the current state of knowledge leads to the fact that we cannot conclude that performance of different lots of demineralized bone allografts in in vivo or in vitro test systems can be used as a measure of clinical performance. It may be possible to adopt an osteoinductivity standard for release-to-market, but it should be followed by clinical monitoring and further research.


Demineralized bone Ethylene Oxide Irradiation Osteoinduction Sterilization 



Bone morphogenetic protein




Demineralized bone powder


Enzyme-linked immunosorbent assay


Ethylene oxide


Human dermal fibroblasts


Recombinant human BMP-2


A line of human osteosarcoma cells


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Copyright information

© Springer 2005

Authors and Affiliations

  • Julie Glowacki
    • 1
  1. 1.Department of Orthopedic SurgeryBrigham and Women’s HospitalBostonUSA

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