Virus safety of a porcine‐derived medical device: Evaluation of a viral inactivation method

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Abstract
The goal of this study was to evaluate the efficacy of a virus‐inactivating process for use during the preparation of porcine‐derived extracellular matrix biomaterials for human clinical implantation. Porcine small intestine, the source material for the tissue‐engineered, small intestinal submucosa (SIS) biomaterial, was evaluated. Relevant enveloped, non‐enveloped, and model viruses representative of different virus families were included in the investigation: porcine parvovirus (PPV), porcine reovirus, murine leukemia retrovirus (LRV), and porcine pseudorabies (herpes) virus (PRV). Samples of small intestine were deliberately inoculated with approximately 1 × 107 plaque‐forming units (PFU) of virus which were thereafter exposed to a 0.18% peracetic acid/4.8% aqueous ethanol mixture for time periods ranging from 5 minutes to 2 hours. Enveloped viruses were more easily inactivated than non‐enveloped viruses, but material processed for 30 minutes or longer inactivated all of the viruses. D10 values were calculated and used to extrapolate the extent of inactivation after 2 hours. Viral titers were reduced by more than 14.0 log10 PPV, 21.0 log10 reovirus, 40.0 log10 PRV, and 27.0 log10 LRV, meeting international standards for viral sterility. These results demonstrate that treatment of porcine small intestine with a peracetic acid/ethanol solution leads to a virus‐free, non‐crosslinked biomaterial safe for xenotransplantation into humans. © 2002 Wiley Periodicals, Inc. Biotechnol Bioeng 79: 211–216, 2002.