| Address |
1Department of Biological Sciences and Biotechnology, Center for Biopharmaceuticals Safety Validation, Hannam University, Daejeon 305-811, Republic of Korea, 2R&D Center, Bioland Co. Ltd, Cheongwon 363-885, Republic of Korea |
| Abstract |
Most types of collagen used for biomedical applications, such as cell therapy and tissue engineering, are derived from animal tissues. Therefore, special precautions must be taken during the production of these proteins in order to assure against the possibility of the products transmitting infectious diseases to the recipients. The ability to remove and/or inactivate known and potential viral contaminants during the manufacturing process is an ever-increasingly important parameter in assessing the safety of biomedical products. The purpose of this study was to evaluate the efficacies of the 70% ethanol treatment and pepsin treatment at pH 2.0 for the inactivation of bovine viruses during the manufacture of collagen type I from bovine hides. A variety of experimental model viruses for bovine viruses including bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), bovine parainfluenza 3 virus (BPIV-3), and bovine parvovirus (BPV), were chosen for the evaluation of viral inactivation efficacy. BHV, BVDV, BPIV-3, and BPV were effectively inactivated to undetectable levels within 1 h of 70% ethanol treatment for 24 h, with log reduction factors of ≥5.58, ≥5.32, ≥5.11, and ≥3.42, respectively. BHV, BVDV, BPIV-3, and BPV were also effectively inactivated to undetectable levels within 5 days of pepsin treatment for 14 days, with the log reduction factors of ≥7.08, ≥6.60, ≥5.60, and ≥3.59, respectively. The cumulative virus reduction factors of BHV, BVDV, BPIV-3, and BPV were ≥12.66, ≥11.92, ≥10.71, and ≥7.01. These results indicate that the production process for collagen type I from bovine hides has a sufficient virus-reducing capacity to achieve a high margin of virus safety. |
