Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia.
Identifieur interne : 002530 ( Main/Exploration ); précédent : 002529; suivant : 002531Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia.
Auteurs : Mahendra Suhardono [Indonésie] ; Dori Ugiyadi ; Ida Nurnaeni ; Imelda EmeliaSource :
- Vaccine [ 1873-2518 ] ; 2011.
Descripteurs français
- KwdFr :
- Essais cliniques comme sujet, Grippe humaine (), Grippe humaine (épidémiologie), Humains, Indonésie (épidémiologie), Pandémies (), Technologie pharmaceutique (), Technologie pharmaceutique (organisation et administration), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (immunologie), Vaccins antigrippaux (ressources et distribution).
- MESH :
- administration et posologie : Vaccins antigrippaux.
- immunologie : Vaccins antigrippaux.
- organisation et administration : Technologie pharmaceutique.
- ressources et distribution : Vaccins antigrippaux.
- épidémiologie : Grippe humaine, Indonésie.
- Essais cliniques comme sujet, Grippe humaine, Humains, Pandémies, Technologie pharmaceutique.
- Wicri :
- geographic : Indonésie.
English descriptors
- KwdEn :
- Clinical Trials as Topic, Humans, Indonesia (epidemiology), Influenza Vaccines (administration & dosage), Influenza Vaccines (immunology), Influenza Vaccines (supply & distribution), Influenza, Human (epidemiology), Influenza, Human (prevention & control), Pandemics (prevention & control), Technology, Pharmaceutical (methods), Technology, Pharmaceutical (organization & administration).
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- geographic , epidemiology : Indonesia.
- chemical , immunology : Influenza Vaccines.
- chemical , supply & distribution : Influenza Vaccines.
- epidemiology : Influenza, Human.
- methods : Technology, Pharmaceutical.
- organization & administration : Technology, Pharmaceutical.
- prevention & control : Influenza, Human, Pandemics.
- Clinical Trials as Topic, Humans.
Abstract
In Indonesia, avian influenza A(H5N1) virus started to spread in humans in June 2005, with an alarming case-fatality rate of more than 80%. Considering that global influenza vaccine production capacity would barely have covered 10% of the world's pandemic vaccine needs, and that countries with no production facilities or prearranged contracts would be without access to a vaccine, the Government of Indonesia embarked on a programme to increase its readiness for a future influenza pandemic. This included the domestic production of influenza vaccine, which was entrusted to Bio Farma. This health security strategy consists of developing trivalent influenza vaccine production capacity in order to be able to convert immediately to monovalent production of up to 20 million pandemic doses for the Indonesian market upon receipt of the seed strain from the World Health Organization (WHO). For this purpose, a dedicated production facility is being constructed within the Bio Farma premises in Bandung. As an initial stage of influenza vaccine development, imported seasonal influenza bulk has been formulated and filled in the Bio Farma facility. Following three consecutive batches and successful clinical trials, the product was licensed by the Indonesian National Regulatory Authority and distributed commercially for the Hajj programme in 2009. With continued support from its technology transfer partners, Bio Farma is now advancing with the development of upstream processes to produce its own bulk for seasonal and pandemic use.
DOI: 10.1016/j.vaccine.2011.04.123
PubMed: 21684423
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 000F85
- to stream PubMed, to step Curation: 000F85
- to stream PubMed, to step Checkpoint: 000F98
- to stream Ncbi, to step Merge: 001076
- to stream Ncbi, to step Curation: 001076
- to stream Ncbi, to step Checkpoint: 001076
- to stream Main, to step Merge: 002621
- to stream Main, to step Curation: 002530
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia.</title><author><name sortKey="Suhardono, Mahendra" sort="Suhardono, Mahendra" uniqKey="Suhardono M" first="Mahendra" last="Suhardono">Mahendra Suhardono</name><affiliation wicri:level="1"><nlm:affiliation>PT Bio Farma (Persero), Jalan Pasteur No. 28, Bandung 40161, Indonesia. mail@biofarma.co.id</nlm:affiliation><country xml:lang="fr">Indonésie</country><wicri:regionArea>PT Bio Farma (Persero), Jalan Pasteur No. 28, Bandung 40161</wicri:regionArea><wicri:noRegion>Bandung 40161</wicri:noRegion></affiliation></author><author><name sortKey="Ugiyadi, Dori" sort="Ugiyadi, Dori" uniqKey="Ugiyadi D" first="Dori" last="Ugiyadi">Dori Ugiyadi</name></author><author><name sortKey="Nurnaeni, Ida" sort="Nurnaeni, Ida" uniqKey="Nurnaeni I" first="Ida" last="Nurnaeni">Ida Nurnaeni</name></author><author><name sortKey="Emelia, Imelda" sort="Emelia, Imelda" uniqKey="Emelia I" first="Imelda" last="Emelia">Imelda Emelia</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2011">2011</date><idno type="RBID">pubmed:21684423</idno><idno type="pmid">21684423</idno><idno type="doi">10.1016/j.vaccine.2011.04.123</idno><idno type="wicri:Area/PubMed/Corpus">000F85</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000F85</idno><idno type="wicri:Area/PubMed/Curation">000F85</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000F85</idno><idno type="wicri:Area/PubMed/Checkpoint">000F98</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000F98</idno><idno type="wicri:Area/Ncbi/Merge">001076</idno><idno type="wicri:Area/Ncbi/Curation">001076</idno><idno type="wicri:Area/Ncbi/Checkpoint">001076</idno><idno type="wicri:Area/Main/Merge">002621</idno><idno type="wicri:Area/Main/Curation">002530</idno><idno type="wicri:Area/Main/Exploration">002530</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia.</title><author><name sortKey="Suhardono, Mahendra" sort="Suhardono, Mahendra" uniqKey="Suhardono M" first="Mahendra" last="Suhardono">Mahendra Suhardono</name><affiliation wicri:level="1"><nlm:affiliation>PT Bio Farma (Persero), Jalan Pasteur No. 28, Bandung 40161, Indonesia. mail@biofarma.co.id</nlm:affiliation><country xml:lang="fr">Indonésie</country><wicri:regionArea>PT Bio Farma (Persero), Jalan Pasteur No. 28, Bandung 40161</wicri:regionArea><wicri:noRegion>Bandung 40161</wicri:noRegion></affiliation></author><author><name sortKey="Ugiyadi, Dori" sort="Ugiyadi, Dori" uniqKey="Ugiyadi D" first="Dori" last="Ugiyadi">Dori Ugiyadi</name></author><author><name sortKey="Nurnaeni, Ida" sort="Nurnaeni, Ida" uniqKey="Nurnaeni I" first="Ida" last="Nurnaeni">Ida Nurnaeni</name></author><author><name sortKey="Emelia, Imelda" sort="Emelia, Imelda" uniqKey="Emelia I" first="Imelda" last="Emelia">Imelda Emelia</name></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials as Topic</term><term>Humans</term><term>Indonesia (epidemiology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (immunology)</term><term>Influenza Vaccines (supply & distribution)</term><term>Influenza, Human (epidemiology)</term><term>Influenza, Human (prevention & control)</term><term>Pandemics (prevention & control)</term><term>Technology, Pharmaceutical (methods)</term><term>Technology, Pharmaceutical (organization & administration)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Essais cliniques comme sujet</term><term>Grippe humaine ()</term><term>Grippe humaine (épidémiologie)</term><term>Humains</term><term>Indonésie (épidémiologie)</term><term>Pandémies ()</term><term>Technologie pharmaceutique ()</term><term>Technologie pharmaceutique (organisation et administration)</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (immunologie)</term><term>Vaccins antigrippaux (ressources et distribution)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Indonesia</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="supply & distribution" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Technology, Pharmaceutical</term></keywords><keywords scheme="MESH" qualifier="organisation et administration" xml:lang="fr"><term>Technologie pharmaceutique</term></keywords><keywords scheme="MESH" qualifier="organization & administration" xml:lang="en"><term>Technology, Pharmaceutical</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term><term>Pandemics</term></keywords><keywords scheme="MESH" qualifier="ressources et distribution" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Grippe humaine</term><term>Indonésie</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Trials as Topic</term><term>Humans</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais cliniques comme sujet</term><term>Grippe humaine</term><term>Humains</term><term>Pandémies</term><term>Technologie pharmaceutique</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Indonésie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In Indonesia, avian influenza A(H5N1) virus started to spread in humans in June 2005, with an alarming case-fatality rate of more than 80%. Considering that global influenza vaccine production capacity would barely have covered 10% of the world's pandemic vaccine needs, and that countries with no production facilities or prearranged contracts would be without access to a vaccine, the Government of Indonesia embarked on a programme to increase its readiness for a future influenza pandemic. This included the domestic production of influenza vaccine, which was entrusted to Bio Farma. This health security strategy consists of developing trivalent influenza vaccine production capacity in order to be able to convert immediately to monovalent production of up to 20 million pandemic doses for the Indonesian market upon receipt of the seed strain from the World Health Organization (WHO). For this purpose, a dedicated production facility is being constructed within the Bio Farma premises in Bandung. As an initial stage of influenza vaccine development, imported seasonal influenza bulk has been formulated and filled in the Bio Farma facility. Following three consecutive batches and successful clinical trials, the product was licensed by the Indonesian National Regulatory Authority and distributed commercially for the Hajj programme in 2009. With continued support from its technology transfer partners, Bio Farma is now advancing with the development of upstream processes to produce its own bulk for seasonal and pandemic use.</div></front></TEI><affiliations><list><country><li>Indonésie</li></country></list><tree><noCountry><name sortKey="Emelia, Imelda" sort="Emelia, Imelda" uniqKey="Emelia I" first="Imelda" last="Emelia">Imelda Emelia</name><name sortKey="Nurnaeni, Ida" sort="Nurnaeni, Ida" uniqKey="Nurnaeni I" first="Ida" last="Nurnaeni">Ida Nurnaeni</name><name sortKey="Ugiyadi, Dori" sort="Ugiyadi, Dori" uniqKey="Ugiyadi D" first="Dori" last="Ugiyadi">Dori Ugiyadi</name></noCountry><country name="Indonésie"><noRegion><name sortKey="Suhardono, Mahendra" sort="Suhardono, Mahendra" uniqKey="Suhardono M" first="Mahendra" last="Suhardono">Mahendra Suhardono</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/PandemieGrippaleV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002530 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 002530 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= PandemieGrippaleV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= pubmed:21684423
|texte= Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:21684423" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a PandemieGrippaleV1
| This area was generated with Dilib version V0.6.34. |  |