Reduction of the Infectivity of Scrapie Agent as a Model for BSE in the Manufacturing Process of Trasylol
The Trasylol ®manufacturing process was investigated with respect to its capacity for the inactivation/removal of infectivity causing bovine spongiform encephalopathy (BSE). Four process steps were selected for this investigation and scaled down to laboratory scale. Authentic samples of bovine lungs...
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| Veröffentlicht in: | Biologicals 1996-06, Vol.24 (2), p.103-111 |
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| container_title | Biologicals |
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| creator | Gölker, C.F. Whiteman, M.D. Gugel, K.H. Gilles, R. Stadler, P. Kovatch, R.M. Lister, D. Wisher, M.H. Calcagni, C. Hübner, G.E. |
| description | The Trasylol
®manufacturing process was investigated with respect to its capacity for the inactivation/removal of infectivity causing bovine spongiform encephalopathy (BSE). Four process steps were selected for this investigation and scaled down to laboratory scale. Authentic samples of bovine lungs used in the Trasylol
®manufacturing plant were taken and spiked in laboratory scale experiments with high infectious titres of the rodent adapted scrapie strain ME 7 which served as model for BSE. After performing the respective process steps the output samples collected were tested in C57BL mice carrying the
Sincgene. An overall reduction of the infectious agent in the order of 18 log
10was observed, indicating a very high capacity of the Trasylol
®process for the inactivation/removal of the BSE/scrapie agent. The discussed safety strategy for the product leads to the conclusion that Trasylol
®is BSE safe. |
| doi_str_mv | 10.1006/biol.1996.0013 |
| format | Article |
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®manufacturing process was investigated with respect to its capacity for the inactivation/removal of infectivity causing bovine spongiform encephalopathy (BSE). Four process steps were selected for this investigation and scaled down to laboratory scale. Authentic samples of bovine lungs used in the Trasylol
®manufacturing plant were taken and spiked in laboratory scale experiments with high infectious titres of the rodent adapted scrapie strain ME 7 which served as model for BSE. After performing the respective process steps the output samples collected were tested in C57BL mice carrying the
Sincgene. An overall reduction of the infectious agent in the order of 18 log
10was observed, indicating a very high capacity of the Trasylol
®process for the inactivation/removal of the BSE/scrapie agent. The discussed safety strategy for the product leads to the conclusion that Trasylol
®is BSE safe.</description><identifier>ISSN: 1045-1056</identifier><identifier>EISSN: 1095-8320</identifier><identifier>DOI: 10.1006/biol.1996.0013</identifier><identifier>PMID: 8889056</identifier><language>eng</language><publisher>Kent: Elsevier Ltd</publisher><subject>Animals ; aprotinin ; Aprotinin - chemical synthesis ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; bovine spongiform encephalopathy ; Cattle ; disease transmission ; Encephalopathy, Bovine Spongiform - pathology ; Encephalopathy, Bovine Spongiform - virology ; extraction ; hematologic agents ; humans ; inactivation ; lungs ; Medical sciences ; Mice ; Mice, Inbred C57BL ; pathogenicity ; Pharmacology. Drug treatments ; prevention ; proteinase inhibitors ; PrPSc proteins ; PrPSc Proteins - pathogenicity ; Thalamus - pathology ; trypsin inhibitors</subject><ispartof>Biologicals, 1996-06, Vol.24 (2), p.103-111</ispartof><rights>1996 The International Association for Biologicals</rights><rights>1996 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c392t-c5ba266b70993a168d660f9dd68f5f10f5cc76696c63a1d5651f89ed680793643</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1045105696900135$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=3221764$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8889056$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gölker, C.F.</creatorcontrib><creatorcontrib>Whiteman, M.D.</creatorcontrib><creatorcontrib>Gugel, K.H.</creatorcontrib><creatorcontrib>Gilles, R.</creatorcontrib><creatorcontrib>Stadler, P.</creatorcontrib><creatorcontrib>Kovatch, R.M.</creatorcontrib><creatorcontrib>Lister, D.</creatorcontrib><creatorcontrib>Wisher, M.H.</creatorcontrib><creatorcontrib>Calcagni, C.</creatorcontrib><creatorcontrib>Hübner, G.E.</creatorcontrib><title>Reduction of the Infectivity of Scrapie Agent as a Model for BSE in the Manufacturing Process of Trasylol</title><title>Biologicals</title><addtitle>Biologicals</addtitle><description>The Trasylol
®manufacturing process was investigated with respect to its capacity for the inactivation/removal of infectivity causing bovine spongiform encephalopathy (BSE). Four process steps were selected for this investigation and scaled down to laboratory scale. Authentic samples of bovine lungs used in the Trasylol
®manufacturing plant were taken and spiked in laboratory scale experiments with high infectious titres of the rodent adapted scrapie strain ME 7 which served as model for BSE. After performing the respective process steps the output samples collected were tested in C57BL mice carrying the
Sincgene. An overall reduction of the infectious agent in the order of 18 log
10was observed, indicating a very high capacity of the Trasylol
®process for the inactivation/removal of the BSE/scrapie agent. The discussed safety strategy for the product leads to the conclusion that Trasylol
®is BSE safe.</description><subject>Animals</subject><subject>aprotinin</subject><subject>Aprotinin - chemical synthesis</subject><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>bovine spongiform encephalopathy</subject><subject>Cattle</subject><subject>disease transmission</subject><subject>Encephalopathy, Bovine Spongiform - pathology</subject><subject>Encephalopathy, Bovine Spongiform - virology</subject><subject>extraction</subject><subject>hematologic agents</subject><subject>humans</subject><subject>inactivation</subject><subject>lungs</subject><subject>Medical sciences</subject><subject>Mice</subject><subject>Mice, Inbred C57BL</subject><subject>pathogenicity</subject><subject>Pharmacology. Drug treatments</subject><subject>prevention</subject><subject>proteinase inhibitors</subject><subject>PrPSc proteins</subject><subject>PrPSc Proteins - pathogenicity</subject><subject>Thalamus - pathology</subject><subject>trypsin inhibitors</subject><issn>1045-1056</issn><issn>1095-8320</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUtPJCEUhclkjONjtrObDAvjrlqoKihYqvGVaDS2rgkNlx4m1dADVSb976XsjjtXkHO-e7g5IPSLkhklhJ8tfOxnVEo-I4Q239ABJZJVoqnJ9-nesooSxn-gw5z_FYK2XbuP9oUQssgHyD-DHc3gY8DR4eEv4LvgoAhvfthM0twkvfaAz5cQBqwz1vghWuixiwlfzK-wDx9jDzqMTpthTD4s8VOKBnKeAl6Szps-9sdoz-k-w8_deYRer69eLm-r-8ebu8vz-8o0sh4qwxa65nzRESkbTbmwnBMnreXCMUeJY8Z0nEtueLEt44w6IaHYpJMNb5sjdLrNXaf4f4Q8qJXPBvpeB4hjVp1ouWQtL-BsC5oUc07g1Dr5lU4bRYmaulVTt2rqVk3dloHfu-RxsQL7ie_KLP7JztfZ6N4lHYzPn1hT17T7WPDPFnM6Kr1MBXmd1-UBQlnd1HIKElsCSk9vHpLKxkMwYH0qf6Ns9F_t-A4ra50f</recordid><startdate>19960601</startdate><enddate>19960601</enddate><creator>Gölker, C.F.</creator><creator>Whiteman, M.D.</creator><creator>Gugel, K.H.</creator><creator>Gilles, R.</creator><creator>Stadler, P.</creator><creator>Kovatch, R.M.</creator><creator>Lister, D.</creator><creator>Wisher, M.H.</creator><creator>Calcagni, C.</creator><creator>Hübner, G.E.</creator><general>Elsevier Ltd</general><general>Elsevier Science</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>19960601</creationdate><title>Reduction of the Infectivity of Scrapie Agent as a Model for BSE in the Manufacturing Process of Trasylol</title><author>Gölker, C.F. ; Whiteman, M.D. ; Gugel, K.H. ; Gilles, R. ; Stadler, P. ; Kovatch, R.M. ; Lister, D. ; Wisher, M.H. ; Calcagni, C. ; Hübner, G.E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c392t-c5ba266b70993a168d660f9dd68f5f10f5cc76696c63a1d5651f89ed680793643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1996</creationdate><topic>Animals</topic><topic>aprotinin</topic><topic>Aprotinin - chemical synthesis</topic><topic>Biological and medical sciences</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>bovine spongiform encephalopathy</topic><topic>Cattle</topic><topic>disease transmission</topic><topic>Encephalopathy, Bovine Spongiform - pathology</topic><topic>Encephalopathy, Bovine Spongiform - virology</topic><topic>extraction</topic><topic>hematologic agents</topic><topic>humans</topic><topic>inactivation</topic><topic>lungs</topic><topic>Medical sciences</topic><topic>Mice</topic><topic>Mice, Inbred C57BL</topic><topic>pathogenicity</topic><topic>Pharmacology. Drug treatments</topic><topic>prevention</topic><topic>proteinase inhibitors</topic><topic>PrPSc proteins</topic><topic>PrPSc Proteins - pathogenicity</topic><topic>Thalamus - pathology</topic><topic>trypsin inhibitors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gölker, C.F.</creatorcontrib><creatorcontrib>Whiteman, M.D.</creatorcontrib><creatorcontrib>Gugel, K.H.</creatorcontrib><creatorcontrib>Gilles, R.</creatorcontrib><creatorcontrib>Stadler, P.</creatorcontrib><creatorcontrib>Kovatch, R.M.</creatorcontrib><creatorcontrib>Lister, D.</creatorcontrib><creatorcontrib>Wisher, M.H.</creatorcontrib><creatorcontrib>Calcagni, C.</creatorcontrib><creatorcontrib>Hübner, G.E.</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Biologicals</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gölker, C.F.</au><au>Whiteman, M.D.</au><au>Gugel, K.H.</au><au>Gilles, R.</au><au>Stadler, P.</au><au>Kovatch, R.M.</au><au>Lister, D.</au><au>Wisher, M.H.</au><au>Calcagni, C.</au><au>Hübner, G.E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Reduction of the Infectivity of Scrapie Agent as a Model for BSE in the Manufacturing Process of Trasylol</atitle><jtitle>Biologicals</jtitle><addtitle>Biologicals</addtitle><date>1996-06-01</date><risdate>1996</risdate><volume>24</volume><issue>2</issue><spage>103</spage><epage>111</epage><pages>103-111</pages><issn>1045-1056</issn><eissn>1095-8320</eissn><abstract>The Trasylol
®manufacturing process was investigated with respect to its capacity for the inactivation/removal of infectivity causing bovine spongiform encephalopathy (BSE). Four process steps were selected for this investigation and scaled down to laboratory scale. Authentic samples of bovine lungs used in the Trasylol
®manufacturing plant were taken and spiked in laboratory scale experiments with high infectious titres of the rodent adapted scrapie strain ME 7 which served as model for BSE. After performing the respective process steps the output samples collected were tested in C57BL mice carrying the
Sincgene. An overall reduction of the infectious agent in the order of 18 log
10was observed, indicating a very high capacity of the Trasylol
®process for the inactivation/removal of the BSE/scrapie agent. The discussed safety strategy for the product leads to the conclusion that Trasylol
®is BSE safe.</abstract><cop>Kent</cop><pub>Elsevier Ltd</pub><pmid>8889056</pmid><doi>10.1006/biol.1996.0013</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1045-1056 |
| ispartof | Biologicals, 1996-06, Vol.24 (2), p.103-111 |
| issn | 1045-1056 1095-8320 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_78469546 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Animals aprotinin Aprotinin - chemical synthesis Biological and medical sciences Blood. Blood coagulation. Reticuloendothelial system bovine spongiform encephalopathy Cattle disease transmission Encephalopathy, Bovine Spongiform - pathology Encephalopathy, Bovine Spongiform - virology extraction hematologic agents humans inactivation lungs Medical sciences Mice Mice, Inbred C57BL pathogenicity Pharmacology. Drug treatments prevention proteinase inhibitors PrPSc proteins PrPSc Proteins - pathogenicity Thalamus - pathology trypsin inhibitors |
| title | Reduction of the Infectivity of Scrapie Agent as a Model for BSE in the Manufacturing Process of Trasylol |
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