Title |
Process development of a virally-safe dental xenograft material from porcine bones |
Author |
Dong-Myong Kim1,2, Ho-Chang Kang2, Hyung-Joon Cha3, Jung Eun Bae4, and In Seop Kim4* |
Address |
1School of Biological Sciences, Seoul National University, Seoul 08826, Republic of Korea, 2Probiomimetic Research Institute, Purgo, Bundang Technopark, Seongnam 13516, Republic of Korea, 3Chemical Engineering Department, Pohang University of Science and Technology, Pohang 37673, Republic of Korea, 4Department of Biological Sciences & Biotechnology, Center for Biopharmaceuticals Safety Validation, Hannam University, Daejeon 34054, Republic of Korea |
Bibliography |
Korean Journal of Microbiology, 52(2),140-147, 2016 |
DOI |
http://dx.doi.org/10.7845/kjm.2016.6019
|
Key Words |
dental xenograft material, hydroxyapatite, porcine bone, porcine pathogenic viruses, virus inactivation |
Abstract |
A process for manufacturing virally-safe porcine bone hydroxyapatite (HA) has been developed to serve as advanced
xenograft material for dental applications. Porcine bone pieces were defatted with successive treatments of 30% hydrogen peroxide and
80% ethyl alcohol. The defatted porcine bone pieces were heat-treated in an oxygen atmosphere box furnace at 1,300°C to remove
collagen and organic compounds. The bone pieces were ground with a grinder and then the bone powder was sterilized by gamma
irradiation. Morphological characteristics such as SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscopy)
images of the resulting porcine bone HA (THE Graft®) were similar to those of a commercial bovine bone HA (Bio-Oss®). In order to
evaluate the efficacy of 1,300°C heat treatment and gamma irradiation at a dose of 25 kGy for the inactivation of porcine viruses during the
manufacture of porcine bone HA, a variety of experimental porcine viruses including transmissible gastroenteritis virus (TGEV),
pseudorabies virus (PRV), porcine rotavirus (PRoV), and porcine parvovirus (PPV) were chosen. TGEV, PRV, PRoV, and PPV were
completely inactivated to undetectable levels during the 1,300ºC heat treatment. The mean log reduction factors achieved were ≧4.65
for TGEV, ≧5.81 for PRV, ≧6.28 for PRoV, and ≧5.21 for PPV. Gamma irradiation was also very effective at inactivating the viruses. TGEV,
PRV, PRoV, and PPV were completely inactivated to undetectable levels during the gamma irradiation. The mean log reduction factors
achieved were ≧4.65 for TGEV, ≧5.87 for PRV, ≧6.05 for PRoV, and ≧4.89 for PPV. The cumulative log reduction factors achieved using
the two different virus inactivation processes were ≧9.30 for TGEV, ≧11.68 for PRV, ≧12.33 for PRoV, and ≧10.10 for PPV. These results
indicate that the manufacturing process for porcine bone HA from porcine-bone material has sufficient virus-reducing capacity to
achieve a high margin of virus safety. |
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52(2)_02_p.140-147.pdf |