Material origin & safety
maxgraft® bonebuilder is produced at the Cells+Tissuebank Austria (C+TBA), a non-profit organization aiming to provide allografts for orthopedic and dental regeneration situated in Krems/Austria.
maxgraft® bonebuilder is made from cancellous human donor bone and originates from femoral heads (taken during hip surgery) of living donors from certified procurement centers in Europe. C+TBA is certified and audited by the Austrian Ministry of Health in accordance with the European Directives regarding donation, procurement, testing, processing, storage and distribution of human tissues and cells (2004/23EC, 2006/17EC, 2006/86EC) and regulated by the Austrian Tissue Safety Act (GSG 2009).
maxgraft® products are safe for use without a single reported case of disease transmission. All tissue donors are routinely screened for infections according to established tissue banking standards. Only tissue that has been tested negative for HIV, Hepatitis B and C, and syphilis enters the Allotec® process of the C+TBA, whose critical viral inactivation steps has been validated independently. During the Allotec® process all non-collagenic proteins are either removed or denatured to eliminate potential antigenicity.
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The Allotec® Process
After thorough removal of the surrounding soft tissue, fat and cartilage, the tissue is shaped into its final form. In the ultrasound bath, blood, cell and tissue components are washed out, but in particular the fat tissue is removed from the cancellous structure of the bone.
In the purification process with volatile reagents, non-collagenous proteins are denatured, potential viruses inactivated and bacteria killed. In the subsequent oxidative treatment, persistent soluble proteins are denatured and potential antigenicity is eliminated.
Finally, the tissue is lyophilised. In this tissue-preserving drying process, frozen tissue water is sublimated from the solid phase into the gaseous phase. The natural structure of the tissue is preserved. Lyophilisation preserves the structural properties of the tissue, accelerating the incorporation of the graft.1-3
Sterilisation by gamma irradiation ensures a sterility assurance level with a SAL value of 10-6 while maintaining the structural and functional integrity of the material and packaging.
References
1 Turner, D. W., & Mellonig, J. T. 1981. Antigenicity of freeze-dried bone aIlograft in periodontal osseous defects. Journal of periodontal research, 16(1), 89-99.
2 Barbeck et al. 2019. Balancing Purification and Ultrastructure of Naturally Derived Bone Blocks for Bone Regeneration: Report of the Purification Effort of Two Bone Blocks. Materials (Basel), 12, 3234-3247.
3 Trajkovski et al. 2018. Hydrophilicity, Viscoelastic, and Physicochemical Properties Variations in Dental Bone Grafting Substitutes. Materials (Basel) Jan 30;11(2).
Support/Contact
Mr. Goran Nikoloski +49 30 20 60 73 98 35
Ms. Gina Grosser +49 30 20 60 73 98 68
Ms. Kristina Domann +49 30 20 60 73 98 26