Purification of severe acute respiratory syndrome hyperimmune globulins for intravenous injection from convalescent plasma
Identifieur interne : 004B18 ( Main/Exploration ); précédent : 004B17; suivant : 004B19Purification of severe acute respiratory syndrome hyperimmune globulins for intravenous injection from convalescent plasma
Auteurs : Zhan Zhang [Hong Kong] ; Yi-Wu Xie [Hong Kong] ; Jiling Hong [Hong Kong] ; Xin Zhang [Hong Kong] ; Sui Yi Kwok [Hong Kong] ; Xiaowu Huang [Hong Kong] ; Sai Wah Wong [Hong Kong] ; Bing-Lou Wong [Hong Kong]Source :
- Transfusion [ 0041-1132 ] ; 2005-07.
Descripteurs français
- KwdFr :
- Anticorps antiviraux (sang), Convalescence, Dimérisation, Globulines (), Globulines (isolement et purification), Humains, Injections veineuses, Plasma sanguin (immunologie), Syndrome respiratoire aigu sévère (), Syndrome respiratoire aigu sévère (immunologie), Syndrome respiratoire aigu sévère (sang), Technique d'immunofluorescence indirecte, Test ELISA, Tests de neutralisation, Virus du SRAS (immunologie).
- MESH :
- immunologie : Plasma sanguin, Syndrome respiratoire aigu sévère, Virus du SRAS.
- isolement et purification : Globulines.
- sang : Anticorps antiviraux, Syndrome respiratoire aigu sévère.
- Convalescence, Dimérisation, Globulines, Humains, Injections veineuses, Syndrome respiratoire aigu sévère, Technique d'immunofluorescence indirecte, Test ELISA, Tests de neutralisation.
English descriptors
- KwdEn :
- Antibodies, Viral (blood), Convalescence, Dimerization, Enzyme-Linked Immunosorbent Assay, Fluorescent Antibody Technique, Indirect, Globulins (chemistry), Globulins (isolation & purification), Humans, Injections, Intravenous, Neutralization Tests, Plasma (immunology), SARS Virus (immunology), Severe Acute Respiratory Syndrome (blood), Severe Acute Respiratory Syndrome (immunology), Severe Acute Respiratory Syndrome (prevention & control).
- MESH :
- chemical , blood : Antibodies, Viral.
- chemical , chemistry : Globulins.
- chemical , isolation & purification : Globulins.
- blood : Severe Acute Respiratory Syndrome.
- immunology : Plasma, SARS Virus, Severe Acute Respiratory Syndrome.
- prevention & control : Severe Acute Respiratory Syndrome.
- Teeft :
- Abnormal toxicity, Assay, Biologics, Chinese requirements, Convalescence, Convalescent, Convalescent plasma, Dimer, Dimerization, Elisa, Enzyme-Linked Immunosorbent Assay, Ethanol, Ethanol precipitation, Fluorescent Antibody Technique, Indirect, Globulin, Heat stability, Hong kong, Human sars hyperimmune globulins, Humans, Hyperimmune, Hyperimmune globulins, Injections, Intravenous, Ivig, July, Neutralization Tests, Neutralizing, Neutralizing antibody test, Precipitation, Respiratory syndrome, Sars, Sars antibody titer, Sars convalescent plasma, Sars hyperimmune globulins, Sars virus, Syndrome, Titer, Titer recovery, Tnbp, Transfusion, Transfusion volume, Triton, Wong, Zhang.
Abstract
BACKGROUND: Severe acute respiratory syndrome (SARS) is a new infectious disease caused by the SARS virus. Current first‐line treatments are experimental, and their effectiveness remains open to question. For more effective treatment and prevention of SARS, human SARS hyperimmune globulins for intravenous (IV) injection were purified in this study. STUDY DESIGN AND METHODS: A combination of cold ethanol precipitation and ion‐exchange chromatography was used to process pooled SARS convalescent plasma samples. Virus inactivation and removal approaches were taken to ensure safety. RESULTS: The purified hyperimmune globulins were formulated as a 5 percent solution, with an antibody titer specifically against the SARS virus of 1:83, 1:1600, and 1:200, as determined by enzyme‐linked immunosorbent assay, immunofluorescence assay, and neutralizing antibody test, respectively. The purity of the SARS hyperimmune globulins was 99.0 percent, and the monomer and dimer content was 100 percent. Other variables analyzed met the Chinese Requirements of Biologics for IV immune globulin. The SARS hyperimmune globulins prepared were subsequently approved for clinical evaluation by the Chinese National Institute for the Control of Pharmaceutical & Biological Products. CONCLUSION: IV‐injectable, purified, and concentrated human SARS hyperimmune globulins were prepared from pooled convalescent plasma samples, which are ready to be further evaluated.
Url:
DOI: 10.1111/j.1537-2995.2005.00179.x
Affiliations:
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Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation></author><author><name sortKey="Xie, Yi U" sort="Xie, Yi U" uniqKey="Xie Y" first="Yi-Wu" last="Xie">Yi-Wu Xie</name><affiliation wicri:level="1"><country xml:lang="fr">Hong Kong</country><wicri:regionArea>From Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation></author><author><name sortKey="Hong, Jiling" sort="Hong, Jiling" uniqKey="Hong J" first="Jiling" last="Hong">Jiling Hong</name><affiliation wicri:level="1"><country xml:lang="fr">Hong Kong</country><wicri:regionArea>From Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Xin" sort="Zhang, Xin" uniqKey="Zhang X" first="Xin" last="Zhang">Xin Zhang</name><affiliation wicri:level="1"><country xml:lang="fr">Hong Kong</country><wicri:regionArea>From Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation></author><author><name sortKey="Kwok, Sui Yi" sort="Kwok, Sui Yi" uniqKey="Kwok S" first="Sui Yi" last="Kwok">Sui Yi Kwok</name><affiliation wicri:level="1"><country xml:lang="fr">Hong Kong</country><wicri:regionArea>From Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation></author><author><name sortKey="Huang, Xiaowu" sort="Huang, Xiaowu" uniqKey="Huang X" first="Xiaowu" last="Huang">Xiaowu Huang</name><affiliation wicri:level="1"><country xml:lang="fr">Hong Kong</country><wicri:regionArea>From Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation></author><author><name sortKey="Wong, Sai Wah" sort="Wong, Sai Wah" uniqKey="Wong S" first="Sai Wah" last="Wong">Sai Wah Wong</name><affiliation wicri:level="1"><country xml:lang="fr">Hong Kong</country><wicri:regionArea>From Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation></author><author><name sortKey="Wong, Bing Ou" sort="Wong, Bing Ou" uniqKey="Wong B" first="Bing-Lou" last="Wong">Bing-Lou Wong</name><affiliation wicri:level="1"><country xml:lang="fr">Hong Kong</country><wicri:regionArea>From Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, P.R. China; and Advantek Biologics (HK) Ltd., Shatin, N.T.</wicri:regionArea><wicri:noRegion>N.T.</wicri:noRegion></affiliation><affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Transfusion</title><title level="j" type="alt">TRANSFUSION</title><idno type="ISSN">0041-1132</idno><idno type="eISSN">1537-2995</idno><imprint><biblScope unit="vol">45</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="1160">1160</biblScope><biblScope unit="page" to="1164">1164</biblScope><biblScope unit="page-count">5</biblScope><publisher>Blackwell Science Inc</publisher><pubPlace>Oxford, UK and Malden, USA</pubPlace><date type="published" when="2005-07">2005-07</date></imprint><idno type="ISSN">0041-1132</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0041-1132</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibodies, Viral (blood)</term><term>Convalescence</term><term>Dimerization</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Fluorescent Antibody Technique, Indirect</term><term>Globulins (chemistry)</term><term>Globulins (isolation & purification)</term><term>Humans</term><term>Injections, Intravenous</term><term>Neutralization Tests</term><term>Plasma (immunology)</term><term>SARS Virus (immunology)</term><term>Severe Acute Respiratory Syndrome (blood)</term><term>Severe Acute Respiratory Syndrome (immunology)</term><term>Severe Acute Respiratory Syndrome (prevention & control)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Anticorps antiviraux (sang)</term><term>Convalescence</term><term>Dimérisation</term><term>Globulines ()</term><term>Globulines (isolement et purification)</term><term>Humains</term><term>Injections veineuses</term><term>Plasma sanguin (immunologie)</term><term>Syndrome respiratoire aigu sévère ()</term><term>Syndrome respiratoire aigu sévère (immunologie)</term><term>Syndrome respiratoire aigu sévère (sang)</term><term>Technique d'immunofluorescence indirecte</term><term>Test ELISA</term><term>Tests de neutralisation</term><term>Virus du SRAS (immunologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Globulins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="isolation & purification" xml:lang="en"><term>Globulins</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Severe Acute Respiratory Syndrome</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Plasma sanguin</term><term>Syndrome respiratoire aigu sévère</term><term>Virus du SRAS</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Plasma</term><term>SARS Virus</term><term>Severe Acute Respiratory Syndrome</term></keywords><keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr"><term>Globulines</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Severe Acute Respiratory Syndrome</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term><term>Syndrome respiratoire aigu sévère</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Abnormal toxicity</term><term>Assay</term><term>Biologics</term><term>Chinese requirements</term><term>Convalescence</term><term>Convalescent</term><term>Convalescent plasma</term><term>Dimer</term><term>Dimerization</term><term>Elisa</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Ethanol</term><term>Ethanol precipitation</term><term>Fluorescent Antibody Technique, Indirect</term><term>Globulin</term><term>Heat stability</term><term>Hong kong</term><term>Human sars hyperimmune globulins</term><term>Humans</term><term>Hyperimmune</term><term>Hyperimmune globulins</term><term>Injections, Intravenous</term><term>Ivig</term><term>July</term><term>Neutralization Tests</term><term>Neutralizing</term><term>Neutralizing antibody test</term><term>Precipitation</term><term>Respiratory syndrome</term><term>Sars</term><term>Sars antibody titer</term><term>Sars convalescent plasma</term><term>Sars hyperimmune globulins</term><term>Sars virus</term><term>Syndrome</term><term>Titer</term><term>Titer recovery</term><term>Tnbp</term><term>Transfusion</term><term>Transfusion volume</term><term>Triton</term><term>Wong</term><term>Zhang</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Convalescence</term><term>Dimérisation</term><term>Globulines</term><term>Humains</term><term>Injections veineuses</term><term>Syndrome respiratoire aigu sévère</term><term>Technique d'immunofluorescence indirecte</term><term>Test ELISA</term><term>Tests de neutralisation</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: Severe acute respiratory syndrome (SARS) is a new infectious disease caused by the SARS virus. Current first‐line treatments are experimental, and their effectiveness remains open to question. For more effective treatment and prevention of SARS, human SARS hyperimmune globulins for intravenous (IV) injection were purified in this study. STUDY DESIGN AND METHODS: A combination of cold ethanol precipitation and ion‐exchange chromatography was used to process pooled SARS convalescent plasma samples. Virus inactivation and removal approaches were taken to ensure safety. RESULTS: The purified hyperimmune globulins were formulated as a 5 percent solution, with an antibody titer specifically against the SARS virus of 1:83, 1:1600, and 1:200, as determined by enzyme‐linked immunosorbent assay, immunofluorescence assay, and neutralizing antibody test, respectively. The purity of the SARS hyperimmune globulins was 99.0 percent, and the monomer and dimer content was 100 percent. Other variables analyzed met the Chinese Requirements of Biologics for IV immune globulin. The SARS hyperimmune globulins prepared were subsequently approved for clinical evaluation by the Chinese National Institute for the Control of Pharmaceutical & Biological Products. CONCLUSION: IV‐injectable, purified, and concentrated human SARS hyperimmune globulins were prepared from pooled convalescent plasma samples, which are ready to be further evaluated.</div></front></TEI><affiliations><list><country><li>Hong Kong</li></country></list><tree><country name="Hong Kong"><noRegion><name sortKey="Zhang, Zhan" sort="Zhang, Zhan" uniqKey="Zhang Z" first="Zhan" last="Zhang">Zhan Zhang</name></noRegion><name sortKey="Hong, Jiling" sort="Hong, Jiling" uniqKey="Hong J" first="Jiling" last="Hong">Jiling Hong</name><name sortKey="Huang, Xiaowu" sort="Huang, Xiaowu" uniqKey="Huang X" first="Xiaowu" last="Huang">Xiaowu Huang</name><name sortKey="Kwok, Sui Yi" sort="Kwok, Sui Yi" uniqKey="Kwok S" first="Sui Yi" last="Kwok">Sui Yi Kwok</name><name sortKey="Wong, Bing Ou" sort="Wong, Bing Ou" uniqKey="Wong B" first="Bing-Lou" last="Wong">Bing-Lou Wong</name><name sortKey="Wong, Sai Wah" sort="Wong, Sai Wah" uniqKey="Wong S" first="Sai Wah" last="Wong">Sai Wah Wong</name><name sortKey="Xie, Yi U" sort="Xie, Yi U" uniqKey="Xie Y" first="Yi-Wu" last="Xie">Yi-Wu Xie</name><name sortKey="Zhang, Xin" sort="Zhang, Xin" uniqKey="Zhang X" first="Xin" last="Zhang">Xin Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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