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KMID : 1234420100380020168
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Korean Journal of Microbiololgy and Biotechnology
2010 Volume.38 No. 2 p.168 ~ p.176
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Virus Inactivation Processes for the Manufacture of Human Acellular Dermal Matrix
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Bae Jung-Eun
Kim Jin-Young
Ahn Jae-Hyung
Choi Da-Mi
Jeong Hyo-Sun
Lee Dong-Hyuck
Kim In-Seop
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Abstract
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Acellular dermal matrix (ADM), produced by decellularization from human cadaveric skin, has been used for various biomedical applications. A manufacturing process for ADM (SureDermTM) using tri-n-butyl phospahate (TnBP) and deoxycholic acids as the decellularization solution has been developed. The manufacturing process for SureDermTM has 70% ethanol treatment and ethylene oxide gas sterilization for inactivating infectious microorganisms. The purpose of this study was to examine the efficacy of the 70% ethanol treatment, decellularization process using 0.1% TnBP and 2% deoxycholic acids, and EO gas sterilization process in the inactivation of viruses. A variety of experimental model viruses for human pathogens, including the human immunodeficiency virus type 1 (HIV- 1), bovine herpes virus (BHV), bovine viral diarrhoea virus (BVDV), hepatitis A virus (HAV), and porcine parvovirus (PPV) were all selected for this study. Enveloped viruses such as HIV-1, BHV, and BVDV were effectively inactivated to undetectable levels by 70% ethanol treatment. However HAV and PPV showed high resistance to 70% ethanol treatment with the log reduction factors of 1.85 and 1.15, respectively. HIV-1, BHV, and BVDV were effectively inactivated to undetectable levels by decellularization process. All the viruses tested were completely inactivated to undetectable levels by EO gas treatment. The cumulative log reduction factors of HIV-1, BHV, BVDV, HAV, and PPV were ≥12.71, ≥18.08, ≥14.92, ≥6.57, and ≥7.18, respectively. These results indicate that the production process for SureDermTM has a sufficient virus-reducing capacity to achieve a high margin of the virus safety.
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KEYWORD
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Acellular dermal matrix, 70% ethanol, decellularization, ethylene oxide, virus inactivation
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