Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system
Identifieur interne : 002685 ( Main/Exploration ); précédent : 002684; suivant : 002686Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system
Auteurs : M. El-Ekiaby [Égypte] ; M. A. Sayed [Égypte] ; C. Caron ; S. Burnouf ; N. El-Sharkawy ; H. Goubran [Égypte] ; M. Radosevich [France] ; J. Goudemand ; D. Blum ; L. De Melo [Suisse] ; V. Soulié [Suisse] ; J. Adam [Suisse] ; T. Burnouf [France, Niger]Source :
- Transfusion Medicine [ 0958-7578 ] ; 2010-02.
Abstract
summary. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (n‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.
Url:
DOI: 10.1111/j.1365-3148.2009.00963.x
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 000224
- to stream Istex, to step Curation: 000224
- to stream Istex, to step Checkpoint: 000556
- to stream Main, to step Merge: 002710
- to stream Main, to step Curation: 002685
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system</title><author><name sortKey="El Kiaby, M" sort="El Kiaby, M" uniqKey="El Kiaby M" first="M." last="El-Ekiaby">M. El-Ekiaby</name></author><author><name sortKey="Sayed, M A" sort="Sayed, M A" uniqKey="Sayed M" first="M. A." last="Sayed">M. A. Sayed</name></author><author><name sortKey="Caron, C" sort="Caron, C" uniqKey="Caron C" first="C." last="Caron">C. Caron</name></author><author><name sortKey="Burnouf, S" sort="Burnouf, S" uniqKey="Burnouf S" first="S." last="Burnouf">S. Burnouf</name></author><author><name sortKey="El Harkawy, N" sort="El Harkawy, N" uniqKey="El Harkawy N" first="N." last="El-Sharkawy">N. El-Sharkawy</name></author><author><name sortKey="Goubran, H" sort="Goubran, H" uniqKey="Goubran H" first="H." last="Goubran">H. Goubran</name></author><author><name sortKey="Radosevich, M" sort="Radosevich, M" uniqKey="Radosevich M" first="M." last="Radosevich">M. Radosevich</name></author><author><name sortKey="Goudemand, J" sort="Goudemand, J" uniqKey="Goudemand J" first="J." last="Goudemand">J. Goudemand</name></author><author><name sortKey="Blum, D" sort="Blum, D" uniqKey="Blum D" first="D." last="Blum">D. Blum</name></author><author><name sortKey="De Melo, L" sort="De Melo, L" uniqKey="De Melo L" first="L." last="De Melo">L. De Melo</name></author><author><name sortKey="Soulie, V" sort="Soulie, V" uniqKey="Soulie V" first="V." last="Soulié">V. Soulié</name></author><author><name sortKey="Adam, J" sort="Adam, J" uniqKey="Adam J" first="J." last="Adam">J. Adam</name></author><author><name sortKey="Burnouf, T" sort="Burnouf, T" uniqKey="Burnouf T" first="T." last="Burnouf">T. Burnouf</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:8988084FA233EB25C3C917D75790C16F633E0838</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1111/j.1365-3148.2009.00963.x</idno><idno type="url">https://api.istex.fr/ark:/67375/WNG-H0QB113P-P/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">000224</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">000224</idno><idno type="wicri:Area/Istex/Curation">000224</idno><idno type="wicri:Area/Istex/Checkpoint">000556</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000556</idno><idno type="wicri:doubleKey">0958-7578:2010:El Kiaby M:solvent:detergent:filtered</idno><idno type="wicri:Area/Main/Merge">002710</idno><idno type="wicri:Area/Main/Curation">002685</idno><idno type="wicri:Area/Main/Exploration">002685</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system</title><author><name sortKey="El Kiaby, M" sort="El Kiaby, M" uniqKey="El Kiaby M" first="M." last="El-Ekiaby">M. El-Ekiaby</name><affiliation wicri:level="1"><country xml:lang="fr">Égypte</country><wicri:regionArea>Shabrawishi Hospital Blood Bank, Giza</wicri:regionArea><wicri:noRegion>Giza</wicri:noRegion></affiliation></author><author><name sortKey="Sayed, M A" sort="Sayed, M A" uniqKey="Sayed M" first="M. A." last="Sayed">M. A. Sayed</name><affiliation wicri:level="1"><country xml:lang="fr">Égypte</country><wicri:regionArea>Fayoum University, Fayoum</wicri:regionArea><wicri:noRegion>Fayoum</wicri:noRegion></affiliation></author><author><name sortKey="Caron, C" sort="Caron, C" uniqKey="Caron C" first="C." last="Caron">C. Caron</name><affiliation><wicri:noCountry code="subField">Lille</wicri:noCountry></affiliation></author><author><name sortKey="Burnouf, S" sort="Burnouf, S" uniqKey="Burnouf S" first="S." last="Burnouf">S. Burnouf</name><affiliation></affiliation><affiliation><wicri:noCountry code="subField">Centre</wicri:noCountry></affiliation></author><author><name sortKey="El Harkawy, N" sort="El Harkawy, N" uniqKey="El Harkawy N" first="N." last="El-Sharkawy">N. El-Sharkawy</name><affiliation><wicri:noCountry code="no comma">National Cancer Institute</wicri:noCountry></affiliation></author><author><name sortKey="Goubran, H" sort="Goubran, H" uniqKey="Goubran H" first="H." last="Goubran">H. Goubran</name><affiliation wicri:level="1"><country xml:lang="fr">Égypte</country><wicri:regionArea>Faculty of Medicine, Cairo University, Cairo</wicri:regionArea><wicri:noRegion>Cairo</wicri:noRegion></affiliation></author><author><name sortKey="Radosevich, M" sort="Radosevich, M" uniqKey="Radosevich M" first="M." last="Radosevich">M. Radosevich</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Human Protein Process Sciences, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Goudemand, J" sort="Goudemand, J" uniqKey="Goudemand J" first="J." last="Goudemand">J. Goudemand</name><affiliation><wicri:noCountry code="subField">Lille</wicri:noCountry></affiliation></author><author><name sortKey="Blum, D" sort="Blum, D" uniqKey="Blum D" first="D." last="Blum">D. Blum</name><affiliation></affiliation><affiliation><wicri:noCountry code="subField">Centre</wicri:noCountry></affiliation></author><author><name sortKey="De Melo, L" sort="De Melo, L" uniqKey="De Melo L" first="L." last="De Melo">L. De Melo</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier</wicri:regionArea><wicri:noRegion>2013 Colombier</wicri:noRegion></affiliation></author><author><name sortKey="Soulie, V" sort="Soulie, V" uniqKey="Soulie V" first="V." last="Soulié">V. Soulié</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier</wicri:regionArea><wicri:noRegion>2013 Colombier</wicri:noRegion></affiliation></author><author><name sortKey="Adam, J" sort="Adam, J" uniqKey="Adam J" first="J." last="Adam">J. Adam</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier</wicri:regionArea><wicri:noRegion>2013 Colombier</wicri:noRegion></affiliation></author><author><name sortKey="Burnouf, T" sort="Burnouf, T" uniqKey="Burnouf T" first="T." last="Burnouf">T. Burnouf</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Human Protein Process Sciences, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Niger</country></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Transfusion Medicine</title><title level="j" type="alt">TRANSFUSION MEDICINE</title><idno type="ISSN">0958-7578</idno><idno type="eISSN">1365-3148</idno><imprint><biblScope unit="vol">20</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="48">48</biblScope><biblScope unit="page" to="61">61</biblScope><biblScope unit="page-count">14</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2010-02">2010-02</date></imprint><idno type="ISSN">0958-7578</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0958-7578</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">summary. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (n‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.</div></front></TEI><affiliations><list><country><li>France</li><li>Niger</li><li>Suisse</li><li>Égypte</li></country><region><li>Hauts-de-France</li><li>Nord-Pas-de-Calais</li></region><settlement><li>Lille</li></settlement></list><tree><noCountry><name sortKey="Blum, D" sort="Blum, D" uniqKey="Blum D" first="D." last="Blum">D. Blum</name><name sortKey="Burnouf, S" sort="Burnouf, S" uniqKey="Burnouf S" first="S." last="Burnouf">S. Burnouf</name><name sortKey="Caron, C" sort="Caron, C" uniqKey="Caron C" first="C." last="Caron">C. Caron</name><name sortKey="El Harkawy, N" sort="El Harkawy, N" uniqKey="El Harkawy N" first="N." last="El-Sharkawy">N. El-Sharkawy</name><name sortKey="Goudemand, J" sort="Goudemand, J" uniqKey="Goudemand J" first="J." last="Goudemand">J. Goudemand</name></noCountry><country name="Égypte"><noRegion><name sortKey="El Kiaby, M" sort="El Kiaby, M" uniqKey="El Kiaby M" first="M." last="El-Ekiaby">M. El-Ekiaby</name></noRegion><name sortKey="Goubran, H" sort="Goubran, H" uniqKey="Goubran H" first="H." last="Goubran">H. Goubran</name><name sortKey="Sayed, M A" sort="Sayed, M A" uniqKey="Sayed M" first="M. A." last="Sayed">M. A. Sayed</name></country><country name="France"><region name="Hauts-de-France"><name sortKey="Radosevich, M" sort="Radosevich, M" uniqKey="Radosevich M" first="M." last="Radosevich">M. Radosevich</name></region><name sortKey="Burnouf, T" sort="Burnouf, T" uniqKey="Burnouf T" first="T." last="Burnouf">T. Burnouf</name></country><country name="Suisse"><noRegion><name sortKey="De Melo, L" sort="De Melo, L" uniqKey="De Melo L" first="L." last="De Melo">L. De Melo</name></noRegion><name sortKey="Adam, J" sort="Adam, J" uniqKey="Adam J" first="J." last="Adam">J. Adam</name><name sortKey="Soulie, V" sort="Soulie, V" uniqKey="Soulie V" first="V." last="Soulié">V. Soulié</name></country><country name="Niger"><noRegion><name sortKey="Burnouf, T" sort="Burnouf, T" uniqKey="Burnouf T" first="T." last="Burnouf">T. Burnouf</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/MersV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002685 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 002685 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= MersV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:8988084FA233EB25C3C917D75790C16F633E0838
|texte= Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system
}}
| This area was generated with Dilib version V0.6.33. |  |