Pathogen‐reduced Ebola virus convalescent plasma: first steps towards standardization of manufacturing and quality control including assessment of Ebola‐specific neutralizing antibodies
Identifieur interne : 001118 ( Main/Exploration ); précédent : 001117; suivant : 001119Pathogen‐reduced Ebola virus convalescent plasma: first steps towards standardization of manufacturing and quality control including assessment of Ebola‐specific neutralizing antibodies
Auteurs : C. Geisen [Allemagne] ; G. Kann [Allemagne] ; T. Strecker [Allemagne] ; T. Wolf [Allemagne] ; G. Schüttfort [Allemagne] ; M. Van Kraaij [Pays-Bas] ; S. Maclennan [Royaume-Uni] ; S. Rummler [Allemagne] ; C. Weinigel [Allemagne] ; M. Eickmann [Allemagne] ; S. K. Fehling [Allemagne] ; V. Kr Hling [Allemagne] ; C. Seidl [Allemagne] ; E. Seifried [Allemagne] ; M. Schmidt [Allemagne] ; R. Sch Fer [Allemagne]Source :
- Vox Sanguinis [ 0042-9007 ] ; 2016-05.
Abstract
Background: Ebola virus disease is a public health emergency of international concern, and enormous efforts are being made in the development of vaccines and therapies. Ebola virus convalescent plasma is a promising anti‐infective treatment of Ebola virus disease. Therefore, we developed and implemented a pathogen‐reduced Ebola virus convalescent plasma concept in accordance with national, European and global regulatory framework. Materials and Methods: Ebola virus convalescent plasma manufacture and distribution was managed by a collection centre, two medical centres and an expert group from the European Blood Alliance. Ebola virus convalescent plasma was collected twice with an interval of 61 days from a donor recovering from Ebola virus disease in Germany. After pathogen reduction, the plasma was analysed for Ebola virus‐specific immunoglobulin G (IgG) antibodies and its Ebola virus neutralizing activity. Results: Convalescent plasma could be collected without adverse events. Anti‐Ebola virus IgG titres and Ebola‐specific neutralizing antibodies in convalescent plasma were only slightly reduced after pathogen reduction treatment with S59 amotosalen/UVA. A patient in Italy with Ebola virus disease was treated with convalescent plasma without apparent adverse effects. Discussion: As proof of principle, we describe a concept and practical implementation of pathogen‐reduced Ebola virus convalescent plasma manufacture, quality control and its clinical application to an Ebola virus disease patient.
Url:
DOI: 10.1111/vox.12376
Affiliations:
- Allemagne, Pays-Bas, Royaume-Uni
- Angleterre, District de Darmstadt, District de Giessen, Grand Londres, Hesse (Land), Hollande-Septentrionale
- Amsterdam, Francfort-sur-le-Main, Londres, Marbourg
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Le document en format XML
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Geisen</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden‐Württemberg‐Hessen gGmbH, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Kann, G" sort="Kann, G" uniqKey="Kann G" first="G." last="Kann">G. Kann</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Infectious Diseases, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Strecker, T" sort="Strecker, T" uniqKey="Strecker T" first="T." last="Strecker">T. Strecker</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Virology, Philipps University Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Wolf, T" sort="Wolf, T" uniqKey="Wolf T" first="T." last="Wolf">T. Wolf</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Infectious Diseases, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Schuttfort, G" sort="Schuttfort, G" uniqKey="Schuttfort G" first="G." last="Schüttfort">G. Schüttfort</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Infectious Diseases, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Van Kraaij, M" sort="Van Kraaij, M" uniqKey="Van Kraaij M" first="M." last="Van Kraaij">M. Van Kraaij</name><affiliation wicri:level="3"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Sanquin Blood Bank, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Maclennan, S" sort="Maclennan, S" uniqKey="Maclennan S" first="S." last="Maclennan">S. Maclennan</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>NHSBT Leeds Centre, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Rummler, S" sort="Rummler, S" uniqKey="Rummler S" first="S." last="Rummler">S. Rummler</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Transfusion Medicine, University Hospital Jena, Jena</wicri:regionArea><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion></affiliation></author><author><name sortKey="Weinigel, C" sort="Weinigel, C" uniqKey="Weinigel C" first="C." last="Weinigel">C. Weinigel</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Transfusion Medicine, University Hospital Jena, Jena</wicri:regionArea><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion></affiliation></author><author><name sortKey="Eickmann, M" sort="Eickmann, M" uniqKey="Eickmann M" first="M." last="Eickmann">M. Eickmann</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Virology, Philipps University Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Fehling, S K" sort="Fehling, S K" uniqKey="Fehling S" first="S. K." last="Fehling">S. K. Fehling</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Virology, Philipps University Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Kr Hling, V" sort="Kr Hling, V" uniqKey="Kr Hling V" first="V." last="Kr Hling">V. Kr Hling</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Virology, Philipps University Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Seidl, C" sort="Seidl, C" uniqKey="Seidl C" first="C." last="Seidl">C. Seidl</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden‐Württemberg‐Hessen gGmbH, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Seifried, E" sort="Seifried, E" uniqKey="Seifried E" first="E." last="Seifried">E. Seifried</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden‐Württemberg‐Hessen gGmbH, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Schmidt, M" sort="Schmidt, M" uniqKey="Schmidt M" first="M." last="Schmidt">M. Schmidt</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden‐Württemberg‐Hessen gGmbH, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation><affiliation></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Allemagne</country></affiliation></author><author><name sortKey="Sch Fer, R" sort="Sch Fer, R" uniqKey="Sch Fer R" first="R." last="Sch Fer">R. Sch Fer</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden‐Württemberg‐Hessen gGmbH, Goethe University Hospital, Frankfurt am Main</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation><affiliation></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Allemagne</country></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Vox Sanguinis</title><title level="j" type="alt">VOX SANGUINIS</title><idno type="ISSN">0042-9007</idno><idno type="eISSN">1423-0410</idno><imprint><biblScope unit="vol">110</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="329">329</biblScope><biblScope unit="page" to="335">335</biblScope><biblScope unit="page-count">7</biblScope><date type="published" when="2016-05">2016-05</date></imprint><idno type="ISSN">0042-9007</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0042-9007</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background: Ebola virus disease is a public health emergency of international concern, and enormous efforts are being made in the development of vaccines and therapies. Ebola virus convalescent plasma is a promising anti‐infective treatment of Ebola virus disease. Therefore, we developed and implemented a pathogen‐reduced Ebola virus convalescent plasma concept in accordance with national, European and global regulatory framework. Materials and Methods: Ebola virus convalescent plasma manufacture and distribution was managed by a collection centre, two medical centres and an expert group from the European Blood Alliance. Ebola virus convalescent plasma was collected twice with an interval of 61 days from a donor recovering from Ebola virus disease in Germany. After pathogen reduction, the plasma was analysed for Ebola virus‐specific immunoglobulin G (IgG) antibodies and its Ebola virus neutralizing activity. Results: Convalescent plasma could be collected without adverse events. Anti‐Ebola virus IgG titres and Ebola‐specific neutralizing antibodies in convalescent plasma were only slightly reduced after pathogen reduction treatment with S59 amotosalen/UVA. A patient in Italy with Ebola virus disease was treated with convalescent plasma without apparent adverse effects. Discussion: As proof of principle, we describe a concept and practical implementation of pathogen‐reduced Ebola virus convalescent plasma manufacture, quality control and its clinical application to an Ebola virus disease patient.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Pays-Bas</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>District de Darmstadt</li><li>District de Giessen</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Hollande-Septentrionale</li></region><settlement><li>Amsterdam</li><li>Francfort-sur-le-Main</li><li>Londres</li><li>Marbourg</li></settlement></list><tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Geisen, C" sort="Geisen, C" uniqKey="Geisen C" first="C." last="Geisen">C. Geisen</name></region><name sortKey="Eickmann, M" sort="Eickmann, M" uniqKey="Eickmann M" first="M." last="Eickmann">M. Eickmann</name><name sortKey="Fehling, S K" sort="Fehling, S K" uniqKey="Fehling S" first="S. K." last="Fehling">S. K. Fehling</name><name sortKey="Kann, G" sort="Kann, G" uniqKey="Kann G" first="G." last="Kann">G. Kann</name><name sortKey="Kr Hling, V" sort="Kr Hling, V" uniqKey="Kr Hling V" first="V." last="Kr Hling">V. Kr Hling</name><name sortKey="Rummler, S" sort="Rummler, S" uniqKey="Rummler S" first="S." last="Rummler">S. Rummler</name><name sortKey="Sch Fer, R" sort="Sch Fer, R" uniqKey="Sch Fer R" first="R." last="Sch Fer">R. Sch Fer</name><name sortKey="Sch Fer, R" sort="Sch Fer, R" uniqKey="Sch Fer R" first="R." last="Sch Fer">R. Sch Fer</name><name sortKey="Schmidt, M" sort="Schmidt, M" uniqKey="Schmidt M" first="M." last="Schmidt">M. Schmidt</name><name sortKey="Schmidt, M" sort="Schmidt, M" uniqKey="Schmidt M" first="M." last="Schmidt">M. Schmidt</name><name sortKey="Schuttfort, G" sort="Schuttfort, G" uniqKey="Schuttfort G" first="G." last="Schüttfort">G. Schüttfort</name><name sortKey="Seidl, C" sort="Seidl, C" uniqKey="Seidl C" first="C." last="Seidl">C. Seidl</name><name sortKey="Seifried, E" sort="Seifried, E" uniqKey="Seifried E" first="E." last="Seifried">E. Seifried</name><name sortKey="Strecker, T" sort="Strecker, T" uniqKey="Strecker T" first="T." last="Strecker">T. Strecker</name><name sortKey="Weinigel, C" sort="Weinigel, C" uniqKey="Weinigel C" first="C." last="Weinigel">C. Weinigel</name><name sortKey="Wolf, T" sort="Wolf, T" uniqKey="Wolf T" first="T." last="Wolf">T. Wolf</name></country><country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Van Kraaij, M" sort="Van Kraaij, M" uniqKey="Van Kraaij M" first="M." last="Van Kraaij">M. Van Kraaij</name></region></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Maclennan, S" sort="Maclennan, S" uniqKey="Maclennan S" first="S." last="Maclennan">S. Maclennan</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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