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  1. Article ; 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  Volume 39, Issue 6, Page(s) 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 term(s) Animals ; Biological Products/analysis ; Cattle ; Drug Contamination/prevention & control ; Host Specificity ; Humans ; Serum/virology ; Swine ; Trypsin/analysis ; Virus Physiological Phenomena ; Viruses/isolation & purification
    Chemical Substances Biological Products ; Trypsin (EC 3.4.21.4)
    Keywords covid19
    Language English
    Publishing date 2011-10-13
    Publishing country England
    Document type 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
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 879: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (1.OG)
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  2. Article: 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.
    Keywords USDA ; Ungulate protoparvovirus 1 ; blood serum ; cattle ; fluorescent antibody technique ; host range ; humans ; manufacturing ; raw materials ; risk ; swine ; trypsin ; viruses ; United States ; covid19
    Language English
    Dates of publication 2011-11
    Size p. 359-369.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2011.08.003
    Database NAL-Catalogue (AGRICOLA)

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 879: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article: 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  Volume 5, Issue 3, Page(s) 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 ... ...

    Institution 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.
    Keywords Enzyme assays ; HIV-1 ; HIV-2 ; Synthetic peptides ; Peptide antisera ; Cross-reactive response ; Chimeric peptides ; Reverse transcriptase ; Integrase ; Peptide diagnostics
    Language English
    Publishing date 1998-07-02
    Publisher S. Karger AG
    Publishing place Basel, Switzerland
    Document type Article
    Note Original Paper
    ZDB-ID 1193378-1
    ISSN 1423-0127 ; 1021-7770
    ISSN (online) 1423-0127
    ISSN 1021-7770
    DOI 10.1159/000025331
    Database Karger publisher's database

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 4037: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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  4. Article: A consensus rating method for small virus-retentive filters. II. Method evaluation.

    Brorson, Kurt / Lute, Scott / Haque, Mohammed / Martin, Jerold / Sato, Terry / Moroe, Ichiro / Morgan, Michael / Krishnan, Mani / Campbell, Jennifer / Genest, Paul / Parrella, Joseph / Dolan, Sherri / Martin, Susan / Tarrach, Klaus / Levy, Richard / Aranha, Hazel / Bailey, Mark / Bender, Jean / Carter, Jeff /
    Chen, Qi / Dowd, Chris / Jani, Raj / Jen, David / Kidd, Stanley / Meltzer, Ted / Remington, Kathryn / Rice, Iris / Romero, Cynthia / Jornitz, Maik / Sekura, Carol Marcus / Sofer, Gail / Specht, Rachel / Wojciechowski, Peter

    PDA journal of pharmaceutical science and technology

    2008  Volume 62, Issue 5, Page(s) 334–343

    Abstract: Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter ... ...

    Abstract Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter Task Force to develop a common nomenclature and a standardized test method for classifying and identifying viral-retentive filters. A test method based on bacteriophage PP7 retention was chosen based on developmental studies. The detailed final consensus filter method is published in the 2008 update of PDA Technical Report 41: Virus Filtration. Here, we evaluate the method and find it to be acceptable for testing scaled-down models of small virus-retentive filters from four manufacturers. Three consecutive lots of five filter types were tested (Pegasus SV4, Viresolve NFP, Planova 20N and 15N, Virosart CPV). Each passed the criteria specified in the test method (i.e., >4 log10 PP7 retention, >90% intravenous immunoglobulin passage, and passing integrity/installation testing) and was classified as PP7-LRV4.
    MeSH term(s) Equipment Design ; Guidelines as Topic ; Immunoglobulins, Intravenous/analysis ; Levivirus/isolation & purification ; Materials Testing ; Membranes, Artificial ; Micropore Filters/standards ; Program Evaluation ; Reproducibility of Results ; Sterilization/instrumentation ; Sterilization/standards
    Chemical Substances Immunoglobulins, Intravenous ; Membranes, Artificial
    Language English
    Publishing date 2008-09
    Publishing country United States
    Document type Evaluation Studies ; Journal Article
    ISSN 1079-7440
    ISSN 1079-7440
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: A consensus rating method for small virus-retentive filters. I. Method development.

    Lute, Scott / Riordan, William / Pease, Leonard F / Tsai, De-Hao / Levy, Richard / Haque, Mohammed / Martin, Jerold / Moroe, Ichiro / Sato, Terry / Morgan, Michael / Krishnan, Mani / Campbell, Jennifer / Genest, Paul / Dolan, Sherri / Tarrach, Klaus / Meyer, Anika / Zachariah, Michael R / Tarlov, Michael J / EtzeL, Mark /
    Brorson, Kurt / Aranha, Hazel / Bailey, Mark / Bender, Jean / Carter, Jeff / Chen, Qi / Dowd, Chris / Jani, Raj / Jen, David / Kidd, Stanley / Meltzer, Ted / Remington, Kathryn / Rice, Iris / Romero, Cynthia / Jornitz, Maik / Sekura, Carol Marcus / Sofer, Gail / Specht, Rachel / Wojciechowski, Peter

    PDA journal of pharmaceutical science and technology

    2008  Volume 62, Issue 5, Page(s) 318–333

    Abstract: Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter ... ...

    Abstract Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter Task Force to develop a common nomenclature and a standardized test method for classifying and identifying viral-retentive filters. One goal of the task force was to develop a test method for small virus-retentive filters. Because small virus-retentive filters present unique technical challenges, the test method development process was guided by laboratory studies to determine critical variables such as choice of bacteriophage challenge, choice of model protein, filtration operating parameters, target log10 reduction value, and filtration endpoint definition. Based on filtration, DLS, electrospray differential mobility analysis, and polymerase chain reaction studies, a final rating based on retention of bacteriophage PP7 was chosen by the PDA Virus Filter Task Force. The detailed final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration.
    MeSH term(s) Advisory Committees ; DNA, Viral/isolation & purification ; Equipment Design ; Feasibility Studies ; Levivirus/genetics ; Levivirus/isolation & purification ; Levivirus/metabolism ; Light ; Materials Testing ; Membranes, Artificial ; Micropore Filters/standards ; Particle Size ; Program Development ; Protein Binding ; Reproducibility of Results ; Reverse Transcriptase Polymerase Chain Reaction ; Scattering, Radiation ; Serum Albumin, Bovine/metabolism ; Sterilization/instrumentation ; Sterilization/standards ; Virion/isolation & purification
    Chemical Substances DNA, Viral ; Membranes, Artificial ; Serum Albumin, Bovine (27432CM55Q)
    Language English
    Publishing date 2008-09
    Publishing country United States
    Document type Guideline ; Journal Article
    ISSN 1079-7440
    ISSN 1079-7440
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: 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

    Volume v. 39,, Issue 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.
    Keywords blood serum ; manufacturing ; host range ; humans ; cattle ; risk ; trypsin ; Ungulate protoparvovirus 1 ; raw materials ; viruses ; USDA ; fluorescent antibody technique ; swine
    Language English
    Document type Article
    ISSN 1045-1056
    Database AGRIS - International Information System for the Agricultural Sciences and Technology

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