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  1. Article ; Online: Omicron Severe Acute Respiratory Syndrome Coronavirus 2 Neutralization by Immunoglobulin Preparations Manufactured From Plasma Collected in the United States and Europe.

    Farcet, Maria R / Karbiener, Michael / Knotzer, Simone / Schwaiger, Julia / Kreil, Thomas R

    The Journal of infectious diseases

    2022  Volume 226, Issue 8, Page(s) 1396–1400

    Abstract: After >2 years of the coronavirus disease 2019 (COVID-19) pandemic, immunoglobulins (IGs) contain highly potent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies, based on the large proportion of United States (US) ... ...

    Abstract After >2 years of the coronavirus disease 2019 (COVID-19) pandemic, immunoglobulins (IGs) contain highly potent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies, based on the large proportion of United States (US) plasma donors who have gone through COVID-19 or vaccination against the virus. Neutralization of Omicron SARS-CoV-2 by antibodies generated after non-Omicron infection or vaccination has been lower though, raising concerns about the potency of IG against this new virus variant. Also, as plasma collected in the US remains the main source of IG, the neutralization of SARS-CoV-2 for plasma collected elsewhere has been less well studied. Here, we confirm Omicron neutralization by US as well as European Union plasma-derived IG lots.
    MeSH term(s) Antibodies, Neutralizing/immunology ; Antibodies, Viral ; COVID-19/immunology ; Europe ; Humans ; Neutralization Tests ; SARS-CoV-2 ; Spike Glycoprotein, Coronavirus ; United States
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
    Language English
    Publishing date 2022-09-02
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiac358
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Virus disinfection for biotechnology applications: Different effectiveness on surface versus in suspension

    Kindermann, Johanna / Karbiener, Michael / Leydold, Sandra M / Knotzer, Simone / Modrof, Jens / Kreil, Thomas R

    Biologicals. 2020 Feb. 04,

    2020  

    Abstract: Virus contamination events in cell culture-based biotechnology processes have occurred and have had a dramatic impact on the supply of life-saving drugs, and thus on the wellbeing of patients. Cleanup requires effective and robust virucidal ... ...

    Abstract Virus contamination events in cell culture-based biotechnology processes have occurred and have had a dramatic impact on the supply of life-saving drugs, and thus on the wellbeing of patients. Cleanup requires effective and robust virucidal decontamination procedures for both the liquid reactor content before discharge, as well as facility surfaces to prevent recurrence. Beyond rare contamination events, it is important to implement virucidal disinfection for change-over procedures as effective preventive measure in routine biomanufacturing. Knowledge of the virus inactivation capacity of commonly used disinfectants is therefore important. However, available virus inactivation data often refer to studies performed in suspension only, and not, as often more relevant, to virus inactivation on surfaces. In this study three liquid disinfectants, based on sodium hypochlorite, glutaraldehyde, or hydrogen peroxide/peroxyacetic acid, as well as one gaseous hydrogen peroxide-based disinfectant were investigated for inactivation of lipid enveloped and non-lipid enveloped model viruses, using suspension (for the liquid disinfectants) and carrier assay designs for their virucidal efficacy on surface. The results of these side-by-side investigations demonstrate that depending on the type of application, i.e. routine surface disinfection or decontamination of e.g. a contaminated bioreactor content, the most effective choice of disinfectant may be remarkably different.
    Keywords bioreactors ; decontamination ; disinfectants ; disinfection ; drugs ; glutaraldehyde ; hydrogen peroxide ; lipids ; liquids ; models ; patients ; peracetic acid ; sodium hypochlorite ; viruses
    Language English
    Dates of publication 2020-0204
    Publishing place Elsevier Ltd
    Document type Article
    Note Pre-press version
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2020.02.002
    Database NAL-Catalogue (AGRICOLA)

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  3. Article ; Online: Virus disinfection for biotechnology applications: Different effectiveness on surface versus in suspension.

    Kindermann, Johanna / Karbiener, Michael / Leydold, Sandra M / Knotzer, Simone / Modrof, Jens / Kreil, Thomas R

    Biologicals : journal of the International Association of Biological Standardization

    2020  Volume 64, Page(s) 1–9

    Abstract: Virus contamination events in cell culture-based biotechnology processes have occurred and have had a dramatic impact on the supply of life-saving drugs, and thus on the wellbeing of patients. Cleanup requires effective and robust virucidal ... ...

    Abstract Virus contamination events in cell culture-based biotechnology processes have occurred and have had a dramatic impact on the supply of life-saving drugs, and thus on the wellbeing of patients. Cleanup requires effective and robust virucidal decontamination procedures for both the liquid reactor content before discharge, as well as facility surfaces to prevent recurrence. Beyond rare contamination events, it is important to implement virucidal disinfection for change-over procedures as effective preventive measure in routine biomanufacturing. Knowledge of the virus inactivation capacity of commonly used disinfectants is therefore important. However, available virus inactivation data often refer to studies performed in suspension only, and not, as often more relevant, to virus inactivation on surfaces. In this study three liquid disinfectants, based on sodium hypochlorite, glutaraldehyde, or hydrogen peroxide/peroxyacetic acid, as well as one gaseous hydrogen peroxide-based disinfectant were investigated for inactivation of lipid enveloped and non-lipid enveloped model viruses, using suspension (for the liquid disinfectants) and carrier assay designs for their virucidal efficacy on surface. The results of these side-by-side investigations demonstrate that depending on the type of application, i.e. routine surface disinfection or decontamination of e.g. a contaminated bioreactor content, the most effective choice of disinfectant may be remarkably different.
    MeSH term(s) Animals ; Cattle ; Chlorocebus aethiops ; Disinfectants/chemistry ; Disinfectants/pharmacology ; Disinfection ; Humans ; Vero Cells ; Virus Inactivation/drug effects ; Viruses/metabolism
    Chemical Substances Disinfectants
    Language English
    Publishing date 2020-02-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2020.02.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Measuring the effectiveness of gaseous virus disinfectants.

    Knotzer, Simone / Kindermann, Johanna / Modrof, Jens / Kreil, Thomas R

    Biologicals : journal of the International Association of Biological Standardization

    2015  Volume 43, Issue 6, Page(s) 519–523

    Abstract: The efficacy of gaseous disinfection is critical for prevention and treatment of microbial contamination in biotechnological facilities. For an evaluation of gaseous disinfection efficacy, a down-scaled laboratory model was established, using currently ... ...

    Abstract The efficacy of gaseous disinfection is critical for prevention and treatment of microbial contamination in biotechnological facilities. For an evaluation of gaseous disinfection efficacy, a down-scaled laboratory model was established, using currently available carrier tests and a custom-made dry fog box. A mixture of peroxyacetic acid and hydrogen peroxide (PAA/HP) was investigated as example, at concentrations between 0.4 and 2.9 mL/m(3) for up to 3 h for inactivation of a panel of lipid-enveloped and non-lipid-enveloped viruses. The influenza viruses were most sensitive to PAA/HP treatment and minute virus of mice was most resistant. Bovine viral diarrhea virus and reovirus III showed intermediate stability and similar inactivation kinetics. Use of the dry fog box circumvents dedicating an entire lab for the investigation, which renders the generation of data more cost-effective and allows for production of highly reproducible kinetic data.
    MeSH term(s) Animals ; Cell Line ; Diarrhea Viruses, Bovine Viral/drug effects ; Diarrhea Viruses, Bovine Viral/physiology ; Disinfectants/pharmacology ; Disinfection ; Drug Evaluation ; Gases ; Hydrogen Peroxide/pharmacology ; Influenza A Virus, H3N2 Subtype/drug effects ; Influenza A Virus, H3N2 Subtype/physiology ; Influenza A Virus, H5N1 Subtype/drug effects ; Influenza A Virus, H5N1 Subtype/physiology ; Influenza B virus/drug effects ; Influenza B virus/physiology ; Mammalian orthoreovirus 3/drug effects ; Mammalian orthoreovirus 3/physiology ; Minute Virus of Mice/drug effects ; Minute Virus of Mice/physiology ; Peracetic Acid/pharmacology ; Time Factors ; Viral Load ; Virology/instrumentation ; Virus Cultivation ; Virus Inactivation/drug effects
    Chemical Substances Disinfectants ; Gases ; Hydrogen Peroxide (BBX060AN9V) ; Peracetic Acid (I6KPI2E1HD)
    Keywords covid19
    Language English
    Publishing date 2015-08-07
    Publishing country England
    Document type Comparative Study ; Journal Article
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2015.06.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Measuring the effectiveness of gaseous virus disinfectants

    Knotzer, Simone / Kindermann, Johanna / Modrof, Jens / Kreil, Thomas R

    The International Alliance for Biological Standardization Biologicals. 2015 Nov., v. 43

    2015  

    Abstract: The efficacy of gaseous disinfection is critical for prevention and treatment of microbial contamination in biotechnological facilities. For an evaluation of gaseous disinfection efficacy, a down-scaled laboratory model was established, using currently ... ...

    Abstract The efficacy of gaseous disinfection is critical for prevention and treatment of microbial contamination in biotechnological facilities. For an evaluation of gaseous disinfection efficacy, a down-scaled laboratory model was established, using currently available carrier tests and a custom-made dry fog box. A mixture of peroxyacetic acid and hydrogen peroxide (PAA/HP) was investigated as example, at concentrations between 0.4 and 2.9 mL/m3 for up to 3 h for inactivation of a panel of lipid-enveloped and non-lipid-enveloped viruses. The influenza viruses were most sensitive to PAA/HP treatment and minute virus of mice was most resistant. Bovine viral diarrhea virus and reovirus III showed intermediate stability and similar inactivation kinetics. Use of the dry fog box circumvents dedicating an entire lab for the investigation, which renders the generation of data more cost-effective and allows for production of highly reproducible kinetic data.
    Keywords Reoviridae ; Rodent protoparvovirus 1 ; Influenza A virus ; disinfectants ; hydrogen peroxide ; microbial contamination ; models ; viruses ; Bovine viral diarrhea virus 1 ; disinfection ; cost effectiveness ; peracetic acid ; covid19
    Language English
    Dates of publication 2015-11
    Size p. 519-523.
    Publishing place Elsevier Ltd
    Document type Article
    Note 2019-12-06
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2015.06.002
    Database NAL-Catalogue (AGRICOLA)

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