Material origin & safety

maxgraft® bonebuilder is produced at the Cells+Tissuebank Austria (C+TBA), a non-profit organization aiming to provide allogenic transplants for orthopedic and dental regeneration situated in Krems/Austria.

maxgraft® bonebuilder is 100% human donor bone and originates from femoral heads (taken during hip endoprosthesis 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, which has been validated to be effective in removing potential contaminants (viruses, bacteria, fungi, spores) and thus provides additional safety. Every step of the production, from explantation in the operation room to final gamma irradiation is performed either in an aseptic or cleanroom environment at pharmaceutical standards within the framework of a GMP-compliant quality management system. During the Allotec® process all non-collagenic proteins are either removed or denatured to eliminate potential antigenicity.

The Allotech® Process

After shaping and crude cleaning, the donor tissue undergoes ultrasonication to remove blood, cells and tissue components, but mainly to promote the removal of fat from the cancellous structure of the bone, improving the penetration of subsequent substances.

During a chemical treatment non-collagenic proteins are denatured, potential viruses are inactivated and bacteria are destroyed. In the subsequent oxidative treatment, persisting soluble proteins are denatured and potential antigenicity is eliminated.
Finally, the tissue undergoes lyophilization, a dehydration technique which facilitates the sublimation of frozen tissue water from solid phase to gas phase, thereby preserving the structural integrity of the material.

The tissue can be reconstituted rapidly due to microscopic pores within the material, which were created by the sublimating ice crystals. It has been well established that the lyophilization process preserves structural properties that improve graft incorporation.1,2

The final sterilization by gamma irradiation guarantees a sterility assurance level (SAL) of 10-6 while ensuring structural and functional integrity of the product and its 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 Flosdorf, E. W., & Hyatt, G. W. (1952). The preservation of bone grafts by freeze-drying. Surgery, 31(5), 716-719.

 

Support/Contact

Mr. Goran Nikoloski
+49 30 20 60 73 98 35
E: bonebuilder@botiss.com