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  1. AU="Marcus-Sekura, Carol"
  2. AU="Petagine, Lucy"
  3. AU="Jessa R. Alexander"
  4. AU=Rauner Martina
  5. AU="Richlen, Mindy L"
  6. AU="Merghani, Nada M"
  7. AU=Splitt M P
  8. AU="Zlatanović, Gordana"

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  1. Artikel ; Online: Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products.

    Marcus-Sekura, Carol / Richardson, James C / Harston, Rebecca K / Sane, Nandini / Sheets, Rebecca L

    Biologicals : journal of the International Association of Biological Standardization

    2011  Band 39, Heft 6, Seite(n) 359–369

    Abstract: Current U.S. requirements for testing cell substrates used in production of human biological products for contamination with bovine and porcine viruses are U.S. Department of Agriculture (USDA) 9CFR tests for bovine serum or porcine trypsin. 9CFR ... ...

    Abstract Current U.S. requirements for testing cell substrates used in production of human biological products for contamination with bovine and porcine viruses are U.S. Department of Agriculture (USDA) 9CFR tests for bovine serum or porcine trypsin. 9CFR requires testing of bovine serum for seven specific viruses in six families (immunofluorescence) and at least 2 additional families non-specifically (cytopathicity and hemadsorption). 9CFR testing of porcine trypsin is for porcine parvovirus. Recent contaminations suggest these tests may not be sufficient. Assay sensitivity was not the issue for these contaminations that were caused by viruses/virus families not represented in the 9CFR screen. A detailed literature search was undertaken to determine which viruses that infect cattle or swine or bovine or porcine cells in culture also have human host range [ability to infect humans or human cells in culture] and to predict their detection by the currently used 9CFR procedures. There are more viruses of potential risk to biological products manufactured using bovine or porcine raw materials than are likely to be detected by 9CFR testing procedures; even within families, not all members would necessarily be detected. Testing gaps and alternative methodologies should be evaluated to continue to ensure safe, high quality human biologicals.
    Mesh-Begriff(e) Animals ; Biological Products/analysis ; Cattle ; Drug Contamination/prevention & control ; Host Specificity ; Humans ; Serum/virology ; Swine ; Trypsin/analysis ; Virus Physiological Phenomena ; Viruses/isolation & purification
    Chemische Substanzen Biological Products ; Trypsin (EC 3.4.21.4)
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2011-10-13
    Erscheinungsland England
    Dokumenttyp Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2011.08.003
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel: Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products

    Marcus-Sekura, Carol / Richardson, James C / Harston, Rebecca K / Sane, Nandini / Sheets, Rebecca L

    Biologicals. 2011 Nov., v. 39, no. 6

    2011  

    Abstract: Current U.S. requirements for testing cell substrates used in production of human biological products for contamination with bovine and porcine viruses are U.S. Department of Agriculture (USDA) 9CFR tests for bovine serum or porcine trypsin. 9CFR ... ...

    Abstract Current U.S. requirements for testing cell substrates used in production of human biological products for contamination with bovine and porcine viruses are U.S. Department of Agriculture (USDA) 9CFR tests for bovine serum or porcine trypsin. 9CFR requires testing of bovine serum for seven specific viruses in six families (immunofluorescence) and at least 2 additional families non-specifically (cytopathicity and hemadsorption). 9CFR testing of porcine trypsin is for porcine parvovirus. Recent contaminations suggest these tests may not be sufficient. Assay sensitivity was not the issue for these contaminations that were caused by viruses/virus families not represented in the 9CFR screen. A detailed literature search was undertaken to determine which viruses that infect cattle or swine or bovine or porcine cells in culture also have human host range [ability to infect humans or human cells in culture] and to predict their detection by the currently used 9CFR procedures. There are more viruses of potential risk to biological products manufactured using bovine or porcine raw materials than are likely to be detected by 9CFR testing procedures; even within families, not all members would necessarily be detected. Testing gaps and alternative methodologies should be evaluated to continue to ensure safe, high quality human biologicals.
    Schlagwörter USDA ; Ungulate protoparvovirus 1 ; blood serum ; cattle ; fluorescent antibody technique ; host range ; humans ; manufacturing ; raw materials ; risk ; swine ; trypsin ; viruses ; United States ; covid19
    Sprache Englisch
    Erscheinungsverlauf 2011-11
    Umfang p. 359-369.
    Erscheinungsort Elsevier Ltd
    Dokumenttyp Artikel
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2011.08.003
    Datenquelle NAL Katalog (AGRICOLA)

    Volltext online

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    Verfügbar in ZB MED Köln/Königswinter

    Zs.A 879: Hefte anzeigen Standort:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
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  3. Artikel: Generation of HIV-1/HIV-2 Cross-Reactive Peptide Antisera by Small Sequence Changes in HIV-1 Reverse Transcriptase and Integrase Immunizing Peptides

    Klutch, Michael / Woerner, Amy M. / Marcus-Sekura, Carol J. / Levin, Judith G.

    Journal of Biomedical Science

    1998  Band 5, Heft 3, Seite(n) 192–202

    Abstract: We have generated peptide antisera against selected regions in HIV-1 and HIV-2 reverse transcriptase (RT) and integrase (IN) to investigate the specificity of determinants governing the immune response. Peptides representing homologous regions (>50%) in ... ...

    Körperschaft Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, and Laboratory of Molecular Genetics, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md., USA
    Abstract We have generated peptide antisera against selected regions in HIV-1 and HIV-2 reverse transcriptase (RT) and integrase (IN) to investigate the specificity of determinants governing the immune response. Peptides representing homologous regions (>50%) in the N- and C-termini and central portions of these proteins were synthesized and injected into rabbits. HIV-1 and HIV-2 IN peptide antisera inhibited IN-mediated cleavage of an HIV-1 DNA oligonucleotide substrate in a 3′ processing assay, while anti-RT or normal sera had no effect. None of the RT sera inhibited RT activity. In Western blots, HIV-2 antisera directed against RT or IN peptides recognized HIV-2 RT and IN proteins, respectively, as expected, but also cross-reacted with the corresponding HIV-1 proteins. By contrast, corresponding HIV-1 antisera were type-specific. In some cases, HIV-1 cross-reactive antisera could be generated by immunization with HIV-1 chimeric peptides with as few as two residues in the HIV-1 sequence changed to the corresponding HIV-2 amino acids. The finding that a type-specific response can be converted to a cross-reactive response suggests alternate strategies for developing new diagnostic reagents which detect HIV-1 and HIV-2. In addition, our results provide a general model for generating HIV peptide vaccines with dual specificity against HIV-1 and HIV-2.
    Schlagwörter Enzyme assays ; HIV-1 ; HIV-2 ; Synthetic peptides ; Peptide antisera ; Cross-reactive response ; Chimeric peptides ; Reverse transcriptase ; Integrase ; Peptide diagnostics
    Sprache Englisch
    Erscheinungsdatum 1998-07-02
    Verlag S. Karger AG
    Erscheinungsort Basel, Switzerland
    Dokumenttyp Artikel
    Anmerkung Original Paper
    ZDB-ID 1193378-1
    ISSN 1423-0127 ; 1021-7770
    ISSN (online) 1423-0127
    ISSN 1021-7770
    DOI 10.1159/000025331
    Datenquelle Karger Verlag

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    Zs.A 4037: Hefte anzeigen Standort:
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  4. Artikel: Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products

    Marcus-Sekura, Carol / Richardson, James C. / Harston, Rebecca K. / Sane, Nandini / Sheets, Rebecca L.

    Biologicals

    Band v. 39,, Heft no. 6

    Abstract: Current U.S. requirements for testing cell substrates used in production of human biological products for contamination with bovine and porcine viruses are U.S. Department of Agriculture (USDA) 9CFR tests for bovine serum or porcine trypsin. 9CFR ... ...

    Abstract Current U.S. requirements for testing cell substrates used in production of human biological products for contamination with bovine and porcine viruses are U.S. Department of Agriculture (USDA) 9CFR tests for bovine serum or porcine trypsin. 9CFR requires testing of bovine serum for seven specific viruses in six families (immunofluorescence) and at least 2 additional families non-specifically (cytopathicity and hemadsorption). 9CFR testing of porcine trypsin is for porcine parvovirus. Recent contaminations suggest these tests may not be sufficient. Assay sensitivity was not the issue for these contaminations that were caused by viruses/virus families not represented in the 9CFR screen. A detailed literature search was undertaken to determine which viruses that infect cattle or swine or bovine or porcine cells in culture also have human host range [ability to infect humans or human cells in culture] and to predict their detection by the currently used 9CFR procedures. There are more viruses of potential risk to biological products manufactured using bovine or porcine raw materials than are likely to be detected by 9CFR testing procedures; even within families, not all members would necessarily be detected. Testing gaps and alternative methodologies should be evaluated to continue to ensure safe, high quality human biologicals.
    Schlagwörter blood serum ; manufacturing ; host range ; humans ; cattle ; risk ; trypsin ; Ungulate protoparvovirus 1 ; raw materials ; viruses ; USDA ; fluorescent antibody technique ; swine
    Sprache Englisch
    Dokumenttyp Artikel
    ISSN 1045-1056
    Datenquelle AGRIS - International Information System for the Agricultural Sciences and Technology

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