Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials
Identifieur interne : 005823 ( Istex/Corpus ); précédent : 005822; suivant : 005824Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials
Auteurs : Kwang-Il Lee ; Jung-Soo Lee ; Hong-Hee Jung ; Hwa-Yong Lee ; Seong-Hwan Moon ; Kyoung-Tak Kang ; Young-Bock Shim ; Ju-Woong JangSource :
- Xenotransplantation [ 0908-665X ] ; 2012-11.
English descriptors
- KwdEn :
- Animalderived bone, Atcc, Biomedical applications, Bone powder, Bovine, Bovine bone, Bovine bone material, Bovine parvovirus, Bvdv, Chemical treatment, Clearance factor, Clearance factors, Cumulative virus, Drug administration, Ethanol, Ethanol solutions, Ethanol treatment, Etoh treatment, Gamma, Gamma irradiation, Human bone tissues, Hydroxide solution, Inactivation, Inactivation step, Inactivation step_1, Inactivation step_2, Inactivation step_3, Infectious viruses, Korea bone bank, Load samples, Manufacturing process, Material volume, Mechanical properties, Medical engineering, Naoh, Naoh treatment, Naoh treatment gamma irradiation, Normal dose, Orthopaedic surgery, Positive control, Reduction factor, Reduction factors, Room temperature, Same volume, Sodium hydroxide, Stock solution, Titration, Undetectable levels, Viral diarrhea virus, Virus, Virus clearance factors, Virus culture media, Virus inactivation, Virus inactivation studies, Virus load, Virus reduction factors, Virus stock solution, Virus titer, Virus titers, Virus titration medium, Viruses desorbed, Xenograft.
- Teeft :
- Animalderived bone, Atcc, Biomedical applications, Bone powder, Bovine, Bovine bone, Bovine bone material, Bovine parvovirus, Bvdv, Chemical treatment, Clearance factor, Clearance factors, Cumulative virus, Drug administration, Ethanol, Ethanol solutions, Ethanol treatment, Etoh treatment, Gamma, Gamma irradiation, Human bone tissues, Hydroxide solution, Inactivation, Inactivation step, Inactivation step_1, Inactivation step_2, Inactivation step_3, Infectious viruses, Korea bone bank, Load samples, Manufacturing process, Material volume, Mechanical properties, Medical engineering, Naoh, Naoh treatment, Naoh treatment gamma irradiation, Normal dose, Orthopaedic surgery, Positive control, Reduction factor, Reduction factors, Room temperature, Same volume, Sodium hydroxide, Stock solution, Titration, Undetectable levels, Viral diarrhea virus, Virus, Virus clearance factors, Virus culture media, Virus inactivation, Virus inactivation studies, Virus load, Virus reduction factors, Virus stock solution, Virus titer, Virus titers, Virus titration medium, Viruses desorbed, Xenograft.
Abstract
Lee K‐I, Lee J‐S, Jung H‐H, Lee H‐Y, Moon S‐H, Kang K‐T, Shim Y‐B, Jang J‐W. Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials. Xenotransplantation 2012; 19: 365–369. © 2012 John Wiley & Sons A/S.
Url:
DOI: 10.1111/xen.12011
Links to Exploration step
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<front><div type="abstract">Lee K‐I, Lee J‐S, Jung H‐H, Lee H‐Y, Moon S‐H, Kang K‐T, Shim Y‐B, Jang J‐W. Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials. Xenotransplantation 2012; 19: 365–369. © 2012 John Wiley & Sons A/S.</div>
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<author xml:id="author-0000"><persName><forename type="first">Kwang‐Il</forename>
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<affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation>
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<affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation>
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<author xml:id="author-0002"><persName><forename type="first">Hong‐Hee</forename>
<surname>Jung</surname>
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<affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation>
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<author xml:id="author-0003"><persName><forename type="first">Hwa‐Yong</forename>
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<affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation>
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<author xml:id="author-0004"><persName><forename type="first">Seong‐Hwan</forename>
<surname>Moon</surname>
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<affiliation>Department of Orthopaedic Surgery, Yonsei University College of Medicine</affiliation>
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<author xml:id="author-0005"><persName><forename type="first">Kyoung‐Tak</forename>
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<affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation>
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<profileDesc><abstract xml:lang="en" style="main"><p>Lee K‐I, Lee J‐S, Jung H‐H, Lee H‐Y, Moon S‐H, Kang K‐T, Shim Y‐B, Jang J‐W. Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials. Xenotransplantation 2012; 19: 365–369. © 2012 John Wiley & Sons A/S.</p>
Abstract
<p><hi rend="bold">Background: </hi>
Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine‐derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone.</p>
<p><hi rend="bold">Methods: </hi>
To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70% ethanol, 4% sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza‐3 virus (BPIV‐3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods.</p>
<p><hi rend="bold">Results: </hi>
The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≥17.73, BHV ≥20.53, BVDV ≥19.00, and BPIV‐3 ≥16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≥16.95, BHV ≥20.22, BVDV ≥19.27, and BPIV‐3 ≥15.58.</p>
<p><hi rend="bold">Conclusions: </hi>
Treatment with 70% ethanol, 4% sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential.</p>
</abstract>
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<correspondenceTo>Address reprint requests to Ju‐Woong Jang, The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd., #608 Acetechnotower 9th. Gasandong, Geumcheongu, Seoul, Korea
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<contentMeta><unparsedEditorialHistory>Received 20 January 2012; Accepted 15 October 2012</unparsedEditorialHistory>
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<p><b>Background: </b>
Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine‐derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone.</p>
<p><b>Methods: </b>
To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70% ethanol, 4% sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza‐3 virus (BPIV‐3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods.</p>
<p><b>Results: </b>
The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≥17.73, BHV ≥20.53, BVDV ≥19.00, and BPIV‐3 ≥16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≥16.95, BHV ≥20.22, BVDV ≥19.27, and BPIV‐3 ≥15.58.</p>
<p><b>Conclusions: </b>
Treatment with 70% ethanol, 4% sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential.</p>
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<abstract>Background: Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine‐derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone. Methods: To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70% ethanol, 4% sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza‐3 virus (BPIV‐3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods. Results: The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≥17.73, BHV ≥20.53, BVDV ≥19.00, and BPIV‐3 ≥16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≥16.95, BHV ≥20.22, BVDV ≥19.27, and BPIV‐3 ≥15.58. Conclusions: Treatment with 70% ethanol, 4% sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential.</abstract>
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