Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products

Detalhes bibliográficos
Autor(a) principal: Codevilla,Cristiane F.
Data de Publicação: 2004
Outros Autores: Barth,Thiago, Brum Júnior,Liberato, Fronza,Marcio, Dalmora,Sérgio L.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Revista brasileira de hematologia e hemoterapia (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842004000200007
Resumo: The identification of rhG-CSF was carried out in pharmaceutical preparations by non-reducing polyacrylamide gel electrophoresis and western blotting with specific antibodies, showing a single band in the 19 kDa region. The potency was assessed by the neutropenia mouse bioassay giving values between 88.4 and 122.4% of the stated potency. The precision index expressed by weight was between 141 and 432 for the independent assays. Batch-to-batch, the samples met the requirements for the safety test and bacterial endotoxins test. The biological and immunological results showed the quality of the products in clinical use and the specifications established contribute to assuring the safety and efficacy of biological medicines.
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spelling Biological potency evaluation and characterization of rhG-CSF in pharmaceutical productsFilgrastimrecombinant human granulocyte colony-stimulating factorneutropeniabioassayThe identification of rhG-CSF was carried out in pharmaceutical preparations by non-reducing polyacrylamide gel electrophoresis and western blotting with specific antibodies, showing a single band in the 19 kDa region. The potency was assessed by the neutropenia mouse bioassay giving values between 88.4 and 122.4% of the stated potency. The precision index expressed by weight was between 141 and 432 for the independent assays. Batch-to-batch, the samples met the requirements for the safety test and bacterial endotoxins test. The biological and immunological results showed the quality of the products in clinical use and the specifications established contribute to assuring the safety and efficacy of biological medicines.Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular2004-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842004000200007Revista Brasileira de Hematologia e Hemoterapia v.26 n.2 2004reponame:Revista brasileira de hematologia e hemoterapia (Online)instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)instacron:ABHHTC10.1590/S1516-84842004000200007info:eu-repo/semantics/openAccessCodevilla,Cristiane F.Barth,ThiagoBrum Júnior,LiberatoFronza,MarcioDalmora,Sérgio L.eng2005-03-09T00:00:00Zoai:scielo:S1516-84842004000200007Revistahttp://www.rbhh.org/pt/archivo/https://old.scielo.br/oai/scielo-oai.phpsbhh@terra.com.br||secretaria@rbhh.org1806-08701516-8484opendoar:2005-03-09T00:00Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)false
dc.title.none.fl_str_mv Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
title Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
spellingShingle Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
Codevilla,Cristiane F.
Filgrastim
recombinant human granulocyte colony-stimulating factor
neutropenia
bioassay
title_short Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
title_full Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
title_fullStr Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
title_full_unstemmed Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
title_sort Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
author Codevilla,Cristiane F.
author_facet Codevilla,Cristiane F.
Barth,Thiago
Brum Júnior,Liberato
Fronza,Marcio
Dalmora,Sérgio L.
author_role author
author2 Barth,Thiago
Brum Júnior,Liberato
Fronza,Marcio
Dalmora,Sérgio L.
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Codevilla,Cristiane F.
Barth,Thiago
Brum Júnior,Liberato
Fronza,Marcio
Dalmora,Sérgio L.
dc.subject.por.fl_str_mv Filgrastim
recombinant human granulocyte colony-stimulating factor
neutropenia
bioassay
topic Filgrastim
recombinant human granulocyte colony-stimulating factor
neutropenia
bioassay
description The identification of rhG-CSF was carried out in pharmaceutical preparations by non-reducing polyacrylamide gel electrophoresis and western blotting with specific antibodies, showing a single band in the 19 kDa region. The potency was assessed by the neutropenia mouse bioassay giving values between 88.4 and 122.4% of the stated potency. The precision index expressed by weight was between 141 and 432 for the independent assays. Batch-to-batch, the samples met the requirements for the safety test and bacterial endotoxins test. The biological and immunological results showed the quality of the products in clinical use and the specifications established contribute to assuring the safety and efficacy of biological medicines.
publishDate 2004
dc.date.none.fl_str_mv 2004-01-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842004000200007
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842004000200007
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S1516-84842004000200007
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular
publisher.none.fl_str_mv Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular
dc.source.none.fl_str_mv Revista Brasileira de Hematologia e Hemoterapia v.26 n.2 2004
reponame:Revista brasileira de hematologia e hemoterapia (Online)
instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)
instacron:ABHHTC
instname_str Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)
instacron_str ABHHTC
institution ABHHTC
reponame_str Revista brasileira de hematologia e hemoterapia (Online)
collection Revista brasileira de hematologia e hemoterapia (Online)
repository.name.fl_str_mv Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)
repository.mail.fl_str_mv sbhh@terra.com.br||secretaria@rbhh.org
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