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
ISTEX:B0AFCB651842235E548D835BE546466F87685268Le document en format XML
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first="Young-Bock" last="Shim">Young-Bock Shim</name><affiliation><mods:affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</mods:affiliation></affiliation></author><author><name sortKey="Jang, Ju Oong" sort="Jang, Ju Oong" uniqKey="Jang J" first="Ju-Woong" last="Jang">Ju-Woong Jang</name><affiliation><mods:affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Xenotransplantation</title><title level="j" type="alt">XENOTRANSPLANTATION</title><idno type="ISSN">0908-665X</idno><idno type="eISSN">1399-3089</idno><imprint><biblScope unit="vol">19</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="365">365</biblScope><biblScope unit="page" to="369">369</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" 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step_3</term><term>Infectious viruses</term><term>Korea bone bank</term><term>Load samples</term><term>Manufacturing process</term><term>Material volume</term><term>Mechanical properties</term><term>Medical engineering</term><term>Naoh</term><term>Naoh treatment</term><term>Naoh treatment gamma irradiation</term><term>Normal dose</term><term>Orthopaedic surgery</term><term>Positive control</term><term>Reduction factor</term><term>Reduction factors</term><term>Room temperature</term><term>Same volume</term><term>Sodium hydroxide</term><term>Stock solution</term><term>Titration</term><term>Undetectable levels</term><term>Viral diarrhea virus</term><term>Virus</term><term>Virus clearance factors</term><term>Virus culture media</term><term>Virus inactivation</term><term>Virus inactivation studies</term><term>Virus load</term><term>Virus reduction factors</term><term>Virus stock solution</term><term>Virus titer</term><term>Virus titers</term><term>Virus titration medium</term><term>Viruses desorbed</term><term>Xenograft</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Animalderived bone</term><term>Atcc</term><term>Biomedical applications</term><term>Bone powder</term><term>Bovine</term><term>Bovine bone</term><term>Bovine bone material</term><term>Bovine parvovirus</term><term>Bvdv</term><term>Chemical treatment</term><term>Clearance factor</term><term>Clearance factors</term><term>Cumulative virus</term><term>Drug administration</term><term>Ethanol</term><term>Ethanol solutions</term><term>Ethanol treatment</term><term>Etoh treatment</term><term>Gamma</term><term>Gamma irradiation</term><term>Human bone tissues</term><term>Hydroxide solution</term><term>Inactivation</term><term>Inactivation step</term><term>Inactivation step_1</term><term>Inactivation step_2</term><term>Inactivation step_3</term><term>Infectious viruses</term><term>Korea bone bank</term><term>Load samples</term><term>Manufacturing process</term><term>Material volume</term><term>Mechanical properties</term><term>Medical engineering</term><term>Naoh</term><term>Naoh treatment</term><term>Naoh treatment gamma irradiation</term><term>Normal dose</term><term>Orthopaedic surgery</term><term>Positive control</term><term>Reduction factor</term><term>Reduction factors</term><term>Room temperature</term><term>Same volume</term><term>Sodium hydroxide</term><term>Stock solution</term><term>Titration</term><term>Undetectable levels</term><term>Viral diarrhea virus</term><term>Virus</term><term>Virus clearance factors</term><term>Virus culture media</term><term>Virus inactivation</term><term>Virus inactivation studies</term><term>Virus load</term><term>Virus reduction factors</term><term>Virus stock solution</term><term>Virus titer</term><term>Virus titers</term><term>Virus titration medium</term><term>Viruses desorbed</term><term>Xenograft</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><istex><corpusName>wiley</corpusName><keywords><teeft><json:string>virus inactivation</json:string><json:string>naoh</json:string><json:string>inactivation</json:string><json:string>bvdv</json:string><json:string>gamma irradiation</json:string><json:string>xenograft</json:string><json:string>bovine</json:string><json:string>ethanol</json:string><json:string>atcc</json:string><json:string>virus titers</json:string><json:string>bovine bone material</json:string><json:string>bone powder</json:string><json:string>bovine bone</json:string><json:string>virus clearance factors</json:string><json:string>titration</json:string><json:string>virus</json:string><json:string>virus culture media</json:string><json:string>etoh treatment</json:string><json:string>naoh treatment</json:string><json:string>manufacturing process</json:string><json:string>virus reduction factors</json:string><json:string>reduction factors</json:string><json:string>undetectable levels</json:string><json:string>animalderived bone</json:string><json:string>korea bone bank</json:string><json:string>biomedical applications</json:string><json:string>sodium hydroxide</json:string><json:string>room temperature</json:string><json:string>chemical treatment</json:string><json:string>same volume</json:string><json:string>stock solution</json:string><json:string>clearance factor</json:string><json:string>gamma</json:string><json:string>cumulative virus</json:string><json:string>inactivation step_3</json:string><json:string>hydroxide solution</json:string><json:string>viral diarrhea virus</json:string><json:string>orthopaedic surgery</json:string><json:string>virus stock solution</json:string><json:string>positive control</json:string><json:string>medical engineering</json:string><json:string>clearance factors</json:string><json:string>reduction factor</json:string><json:string>ethanol treatment</json:string><json:string>virus titration medium</json:string><json:string>inactivation step</json:string><json:string>virus load</json:string><json:string>inactivation step_2</json:string><json:string>bovine parvovirus</json:string><json:string>virus inactivation studies</json:string><json:string>material volume</json:string><json:string>virus titer</json:string><json:string>drug administration</json:string><json:string>ethanol solutions</json:string><json:string>viruses desorbed</json:string><json:string>load samples</json:string><json:string>naoh treatment gamma irradiation</json:string><json:string>human bone tissues</json:string><json:string>normal dose</json:string><json:string>infectious viruses</json:string><json:string>inactivation step_1</json:string><json:string>mechanical properties</json:string></teeft></keywords><author><json:item><name>Kwang‐Il Lee</name><affiliations><json:string>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</json:string></affiliations></json:item><json:item><name>Jung‐Soo Lee</name><affiliations><json:string>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</json:string></affiliations></json:item><json:item><name>Hong‐Hee Jung</name><affiliations><json:string>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</json:string></affiliations></json:item><json:item><name>Hwa‐Yong Lee</name><affiliations><json:string>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</json:string></affiliations></json:item><json:item><name>Seong‐Hwan Moon</name><affiliations><json:string>Department of Orthopaedic Surgery, Yonsei University College of Medicine</json:string></affiliations></json:item><json:item><name>Kyoung‐Tak Kang</name><affiliations><json:string>Department of Mechanical Engineering, Yonsei University, Seoul, Korea</json:string></affiliations></json:item><json:item><name>Young‐Bock Shim</name><affiliations><json:string>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</json:string></affiliations></json:item><json:item><name>Ju‐Woong Jang</name><affiliations><json:string>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>biochemical process</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>bone grafting material</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>gamma irradiation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>virus inactivation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>xenograft</value></json:item></subject><articleId><json:string>XEN12011</json:string></articleId><arkIstex>ark:/67375/WNG-4B4R5N4R-H</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><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.</abstract><qualityIndicators><refBibsNative>true</refBibsNative><abstractWordCount>46</abstractWordCount><abstractCharCount>294</abstractCharCount><keywordCount>5</keywordCount><score>5.24</score><pdfWordCount>2688</pdfWordCount><pdfCharCount>18244</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>5</pdfPageCount><pdfPageSize>595.276 x 782.362 pts</pdfPageSize></qualityIndicators><title>Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials</title><pmid><json:string>23198732</json:string></pmid><genre><json:string>article</json:string></genre><host><title>Xenotransplantation</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1399-3089</json:string></doi><issn><json:string>0908-665X</json:string></issn><eissn><json:string>1399-3089</json:string></eissn><publisherId><json:string>XEN</json:string></publisherId><volume>19</volume><issue>6</issue><pages><first>365</first><last>369</last></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>Original Article</value></json:item></subject></host><namedEntities><unitex><date><json:string>2012</json:string></date><geogName></geogName><orgName><json:string>Department of Mechanical Engineering, Yonsei University, Seoul, Korea Key</json:string><json:string>Korea Bone Bank Co.</json:string><json:string>Institute of Biomaterial and Medical Engineering</json:string><json:string>Department of Orthopaedic Surgery, Yonsei University College of Medicine</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>W. Inactivation</json:string><json:string>Yong Lee</json:string><json:string>John Wiley</json:string><json:string>Hwan Moon</json:string><json:string>S. Kwang</json:string></persName><placeName><json:string>Korea</json:string><json:string>Seoul</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>[7,8]</json:string><json:string>[18]</json:string><json:string>[17]</json:string><json:string>Lee et al.</json:string><json:string>[9]</json:string><json:string>[19]</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/WNG-4B4R5N4R-H</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - transplantation</json:string><json:string>2 - medicine, research & experimental</json:string></wos><scienceMetrix><json:string>1 - health sciences</json:string><json:string>2 - clinical medicine</json:string><json:string>3 - surgery</json:string></scienceMetrix><scopus><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Transplantation</json:string><json:string>1 - Life Sciences</json:string><json:string>2 - Immunology and Microbiology</json:string><json:string>3 - Immunology</json:string></scopus></categories><publicationDate>2012</publicationDate><copyrightDate>2012</copyrightDate><doi><json:string>10.1111/xen.12011</json:string></doi><id>B0AFCB651842235E548D835BE546466F87685268</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/B0AFCB651842235E548D835BE546466F87685268/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/B0AFCB651842235E548D835BE546466F87685268/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/B0AFCB651842235E548D835BE546466F87685268/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main">Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><availability><licence>© 2012 John Wiley & Sons A/S</licence></availability><date type="published" when="2012-11"></date></publicationStmt><notesStmt><note type="content-type" subtype="article" source="article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</note><note type="publication-type" subtype="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="article"><analytic><title level="a" type="main">Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials</title><title level="a" type="short">Virus inactivation of bovine graft</title><author xml:id="author-0000"><persName><forename type="first">Kwang‐Il</forename><surname>Lee</surname></persName><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Jung‐Soo</forename><surname>Lee</surname></persName><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation></author><author xml:id="author-0002"><persName><forename type="first">Hong‐Hee</forename><surname>Jung</surname></persName><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation></author><author xml:id="author-0003"><persName><forename type="first">Hwa‐Yong</forename><surname>Lee</surname></persName><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation></author><author xml:id="author-0004"><persName><forename type="first">Seong‐Hwan</forename><surname>Moon</surname></persName><affiliation>Department of Orthopaedic Surgery, Yonsei University College of Medicine</affiliation></author><author xml:id="author-0005"><persName><forename type="first">Kyoung‐Tak</forename><surname>Kang</surname></persName><affiliation>Department of Mechanical Engineering, Yonsei University, Seoul, Korea<address><country key="KR"></country></address></affiliation></author><author xml:id="author-0006"><persName><forename type="first">Young‐Bock</forename><surname>Shim</surname></persName><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation></author><author xml:id="author-0007"><persName><forename type="first">Ju‐Woong</forename><surname>Jang</surname></persName><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation></author><idno type="istex">B0AFCB651842235E548D835BE546466F87685268</idno><idno type="ark">ark:/67375/WNG-4B4R5N4R-H</idno><idno type="DOI">10.1111/xen.12011</idno><idno type="unit">XEN12011</idno><idno type="toTypesetVersion">file:XEN.XEN12011.pdf</idno></analytic><monogr><title level="j" type="main">Xenotransplantation</title><title level="j" type="alt">XENOTRANSPLANTATION</title><idno type="pISSN">0908-665X</idno><idno type="eISSN">1399-3089</idno><idno type="book-DOI">10.1111/(ISSN)1399-3089</idno><idno type="book-part-DOI">10.1111/xen.2012.19.issue-6</idno><idno type="product">XEN</idno><idno type="publisherDivision">ST</idno><imprint><biblScope unit="vol">19</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="365">365</biblScope><biblScope unit="page" to="369">369</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2012-11"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><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><textClass><keywords xml:lang="en"><term xml:id="k1">biochemical process</term><term xml:id="k2">bone grafting material</term><term xml:id="k3">gamma irradiation</term><term xml:id="k4">virus inactivation</term><term xml:id="k5">xenograft</term></keywords><keywords rend="tocHeading1"><term>Original Articles</term></keywords><keywords rend="articleCategory"><term>Original Article</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/B0AFCB651842235E548D835BE546466F87685268/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Blackwell Publishing Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1399-3089</doi><issn type="print">0908-665X</issn><issn type="electronic">1399-3089</issn><idGroup><id type="product" value="XEN"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="XENOTRANSPLANTATION">Xenotransplantation</title></titleGroup></publicationMeta><publicationMeta level="part" position="11106"><doi origin="wiley">10.1111/xen.2012.19.issue-6</doi><numberingGroup><numbering type="journalVolume" number="19">19</numbering><numbering type="journalIssue" number="6">6</numbering></numberingGroup><coverDate startDate="2012-11">November/December 2012</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="7" status="forIssue"><doi origin="wiley">10.1111/xen.12011</doi><idGroup><id type="unit" value="XEN12011"></id></idGroup><titleGroup><title type="tocHeading1"><sc>Original Articles</sc></title><title type="articleCategory">Original Article</title></titleGroup><copyright>© 2012 John Wiley & Sons A/S</copyright><eventGroup><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:3.1.9 mode:FullText" date="2012-12-02"></event><event type="firstOnline" date="2012-12-02"></event><event type="publishedOnlineFinalForm" date="2012-12-02"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-10"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.3.4 mode:FullText" date="2015-02-25"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="365">365</numbering><numbering type="pageLast" number="369">369</numbering></numberingGroup><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
(E‐mail: <email>orienta@empal.com</email>)</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:XEN.XEN12011.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Received 20 January 2012; Accepted 15 October 2012</unparsedEditorialHistory><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="5"></count></countGroup><titleGroup><title type="main">Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials</title><title type="shortAuthors"><b>Lee et al.</b></title><title type="short"><b>Virus inactivation of bovine graft</b></title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>Kwang‐Il</givenNames><familyName>Lee</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a1"><personName><givenNames>Jung‐Soo</givenNames><familyName>Lee</familyName></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a1"><personName><givenNames>Hong‐Hee</givenNames><familyName>Jung</familyName></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a1"><personName><givenNames>Hwa‐Yong</givenNames><familyName>Lee</familyName></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a2"><personName><givenNames>Seong‐Hwan</givenNames><familyName>Moon</familyName></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a3"><personName><givenNames>Kyoung‐Tak</givenNames><familyName>Kang</familyName></personName></creator><creator creatorRole="author" xml:id="cr7" affiliationRef="#a1"><personName><givenNames>Young‐Bock</givenNames><familyName>Shim</familyName></personName></creator><creator creatorRole="author" xml:id="cr8" affiliationRef="#a1"><personName><givenNames>Ju‐Woong</givenNames><familyName>Jang</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1"><unparsedAffiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</unparsedAffiliation></affiliation><affiliation xml:id="a2"><unparsedAffiliation>Department of Orthopaedic Surgery, Yonsei University College of Medicine</unparsedAffiliation></affiliation><affiliation xml:id="a3" countryCode="KR"><unparsedAffiliation>Department of Mechanical Engineering, Yonsei University, Seoul, Korea</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en"><keyword xml:id="k1">biochemical process</keyword><keyword xml:id="k2">bone grafting material</keyword><keyword xml:id="k3">gamma irradiation</keyword><keyword xml:id="k4">virus inactivation</keyword><keyword xml:id="k5">xenograft</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><section xml:id="sec-sum-1"><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></section><section xml:id="abs1-1"><title type="main">Abstract</title><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></section></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Virus inactivation of bovine graft</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Inactivation of enveloped and non‐enveloped viruses in the process of chemical treatment and gamma irradiation of bovine‐derived grafting materials</title></titleInfo><name type="personal"><namePart type="given">Kwang‐Il</namePart><namePart type="family">Lee</namePart><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jung‐Soo</namePart><namePart type="family">Lee</namePart><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Hong‐Hee</namePart><namePart type="family">Jung</namePart><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Hwa‐Yong</namePart><namePart type="family">Lee</namePart><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Seong‐Hwan</namePart><namePart type="family">Moon</namePart><affiliation>Department of Orthopaedic Surgery, Yonsei University College of Medicine</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kyoung‐Tak</namePart><namePart type="family">Kang</namePart><affiliation>Department of Mechanical Engineering, Yonsei University, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Young‐Bock</namePart><namePart type="family">Shim</namePart><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ju‐Woong</namePart><namePart type="family">Jang</namePart><affiliation>The Institute of Biomaterial and Medical Engineering, Korea Bone Bank Co., Ltd.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2012-11</dateIssued><edition>Received 20 January 2012; Accepted 15 October 2012</edition><copyrightDate encoding="w3cdtf">2012</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">1</extent><extent unit="tables">5</extent></physicalDescription><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.</abstract><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><subject lang="en"><genre>keywords</genre><topic>biochemical process</topic><topic>bone grafting material</topic><topic>gamma irradiation</topic><topic>virus inactivation</topic><topic>xenograft</topic></subject><relatedItem type="host"><titleInfo><title>Xenotransplantation</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>article-category</genre><topic>Original Article</topic></subject><identifier type="ISSN">0908-665X</identifier><identifier type="eISSN">1399-3089</identifier><identifier type="DOI">10.1111/(ISSN)1399-3089</identifier><identifier type="PublisherID">XEN</identifier><part><date>2012</date><detail type="volume"><caption>vol.</caption><number>19</number></detail><detail type="issue"><caption>no.</caption><number>6</number></detail><extent unit="pages"><start>365</start><end>369</end></extent></part></relatedItem><identifier type="istex">B0AFCB651842235E548D835BE546466F87685268</identifier><identifier type="ark">ark:/67375/WNG-4B4R5N4R-H</identifier><identifier type="DOI">10.1111/xen.12011</identifier><identifier type="ArticleID">XEN12011</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2012 John Wiley & Sons A/S</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-L0C46X92-X">wiley</recordContentSource><recordOrigin>Blackwell Publishing Ltd</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/document/B0AFCB651842235E548D835BE546466F87685268/metadata/json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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