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  1. Article ; Online: Tetanus antibodies in normal human immunoglobulin preparations.

    Farcet, Maria R / Lackner, Cornelia / Schirmer, Andreas / Kreil, Thomas R

    Vox sanguinis

    2023  Volume 118, Issue 10, Page(s) 906–907

    Language English
    Publishing date 2023-08-08
    Publishing country England
    Document type Letter
    ZDB-ID 80313-3
    ISSN 1423-0410 ; 0042-9007
    ISSN (online) 1423-0410
    ISSN 0042-9007
    DOI 10.1111/vox.13506
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 74: Show issues Location:
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  2. Article ; Online: Feasibility of identifying plasma donors with high measles neutralizing antibody concentrations for the use of producing a measles hyperimmune globulin for postexposure prophylaxis.

    Lackner, Cornelia / Karbiener, Michael / Faltner, Lukas / Farcet, Maria R / Kreil, Thomas R

    Immunologic research

    2022  Volume 70, Issue 3, Page(s) 365–370

    Abstract: Immune globulin (IG) is administered as measles postexposure prophylaxis (PEP) in people with primary immunodeficiency disorders or individuals not eligible for live virus vaccination. However, measles virus (MeV) neutralizing antibody (nAb) levels in ... ...

    Abstract Immune globulin (IG) is administered as measles postexposure prophylaxis (PEP) in people with primary immunodeficiency disorders or individuals not eligible for live virus vaccination. However, measles virus (MeV) neutralizing antibody (nAb) levels in plasma for fractionation and IG products fractionated thereof have declined. Here, the feasibility of producing a measles hyperimmune globulin (HIG) for PEP of high-risk individuals was investigated. Plasma samples (n = 384) were selected based on donor self-identification for previous MeV infection or vaccination, to determine the MeV-nAb content and compare it to the potency of plasma pools (n = 13) from the current IG manufacture. Convalescent donors have higher mean MeV-nAb concentrations (3.9 IU/mL) than vaccinated donors (2.5 IU/mL), as previously reported. However, their selection would only result in a 1.4-fold elevated nAb concentration compared to current plasma pools, which is not sufficient for HIG production. Interestingly, thirty-two donors (8%) had a MeV-nAb concentration of ≥ 8 IU/mL. The selective use of these plasma donations would result in sixfold higher plasma pool concentrations, which should permit the manufacture of the measles HIG. Further, the longitudinal analysis of a subset of individuals who repeatedly donated plasma at a high frequency revealed only a minor decline (~ 30%) of MeV-nAb levels. Repeat donations of such high-potency donors would thus facilitate the production of the measles HIG. Due to its markedly raised MeV-nAb concentration compared to standard IG, such preparation could significantly shorten infusion time and thus improve the treatment experience for both physicians and patients, especially infants.
    MeSH term(s) Antibodies, Neutralizing ; Antibodies, Viral ; Feasibility Studies ; Humans ; Immunoglobulin G ; Immunoglobulins, Intravenous/therapeutic use ; Infant ; Measles/prevention & control ; Post-Exposure Prophylaxis
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; Immunoglobulin G ; Immunoglobulins, Intravenous
    Language English
    Publishing date 2022-03-09
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632857-x
    ISSN 1559-0755 ; 0257-277X
    ISSN (online) 1559-0755
    ISSN 0257-277X
    DOI 10.1007/s12026-022-09274-z
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    Zs.A 1755: Show issues Location:
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  3. Article ; Online: Neutralization of Rubella Vaccine Virus and Immunodeficiency-Related Vaccine-Derived Rubella Viruses by Intravenous Immunoglobulins.

    Chen, Min-Hsin / Perelygina, Ludmila / Hao, LiJuan / Beard, R Suzanne / Lackner, Cornelia / Farcet, Maria R / Karbiener, Michael / Icenogle, Joseph / Kreil, Thomas R

    The Journal of infectious diseases

    2024  

    Abstract: The association between granulomas and vaccine-derived rubella virus (VDRV) in people with primary immune deficiencies (PID) has raised concerns about the ability of immunoglobulin (IG) preparations to neutralize VDRVs. We investigated the capacity of IG ...

    Abstract The association between granulomas and vaccine-derived rubella virus (VDRV) in people with primary immune deficiencies (PID) has raised concerns about the ability of immunoglobulin (IG) preparations to neutralize VDRVs. We investigated the capacity of IG to neutralize rubella vaccine virus and four VDRV strains. As expected, the rubella vaccine virus itself was potently neutralized by IG preparations; however, the VDRV isolates from patients after intra-host evolution, 2-6 times less so. Diagnosis of immune deficiencies before possible live-virus vaccination is thus of critical importance, while IG replacement therapy can be expected to provide protection from rubella virus infection.
    Language English
    Publishing date 2024-04-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiae182
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    Uh II Zs.50: Show issues Location:
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    Zs.MO 445: Show issues

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  4. Article ; Online: Hepatitis E virus and the safety of plasma products: investigations into the reduction capacity of manufacturing processes.

    Farcet, Maria R / Lackner, Cornelia / Antoine, Gerhard / Rabel, Philip O / Wieser, Andreas / Flicker, Andreas / Unger, Ulrike / Modrof, Jens / Kreil, Thomas R

    Transfusion

    2015  Volume 56, Issue 2, Page(s) 383–391

    Abstract: Background: Hepatitis E virus (HEV) has been transmitted by transfusion of labile blood products and the occasional detection of HEV RNA in plasma pools indicates that HEV viremic donations might enter the manufacturing process of plasma products. To ... ...

    Abstract Background: Hepatitis E virus (HEV) has been transmitted by transfusion of labile blood products and the occasional detection of HEV RNA in plasma pools indicates that HEV viremic donations might enter the manufacturing process of plasma products. To verify the safety margins of plasma products with respect to HEV, virus reduction steps commonly used in their manufacturing processes were investigated for their effectiveness to reduce HEV.
    Study design and methods: Detection methods for HEV removal (by reverse transcription quantitative polymerase chain reaction) and inactivation (using an infectivity assay) were established. Immunoaffinity chromatography and 20-nm virus filtration for Factor (F)VIII, cold ethanol fractionation, and low-pH treatment for immunoglobulin, heat treatment for human albumin, and 35-nm nanofiltration for FVIII inhibitor-bypassing activity (FEIBA) were investigated for their capacity to reduce HEV or the physicochemically similar viruses feline calicivirus (FCV) and hepatitis A virus (HAV).
    Results: For FVIII, HEV reduction of 3.9 and more than 3.9 log was demonstrated for immunoaffinity chromatography and 20-nm nanofiltration, respectively, and the cold ethanol fractionation for immunoglobulin removed more than 3.5 log of HEV, to below the limit of detection (LOD). Heat treatment of human albumin inactivated more than 3.1 log of HEV to below the LOD and 35-nm nanofiltration removed 4.0 log of HEV from the FEIBA intermediate. The results indicated HAV rather than FCV as the more relevant model virus for HEV.
    Conclusion: Substantial HEV reduction during processes commonly used in the manufacturing of plasma products was demonstrated, similar to that previously demonstrated for HAV.
    MeSH term(s) Blood Safety/methods ; Factor VIII/chemistry ; Hep G2 Cells ; Hepatitis E virus ; Humans ; Plasma/chemistry ; Plasma/virology ; Reverse Transcriptase Polymerase Chain Reaction/methods ; Virus Inactivation
    Chemical Substances F8 protein, human (839MOZ74GK) ; Factor VIII (9001-27-8)
    Language English
    Publishing date 2015-09-24
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.13343
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    Zs.A 284: Show issues Location:
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  5. Article ; Online: Reduction of spiked porcine circovirus during the manufacture of a Vero cell-derived vaccine.

    Lackner, Cornelia / Leydold, Sandra M / Modrof, Jens / Farcet, Maria R / Grillberger, Leopold / Schäfer, Birgit / Anderle, Heinz / Kreil, Thomas R

    Vaccine

    2014  Volume 32, Issue 18, Page(s) 2056–2061

    Abstract: Porcine circovirus-1 (PCV1) was recently identified as a contaminant in live Rotavirus vaccines, which was likely caused by contaminated porcine trypsin. The event triggered the development of new regulatory guidance on the use of porcine trypsin which ... ...

    Abstract Porcine circovirus-1 (PCV1) was recently identified as a contaminant in live Rotavirus vaccines, which was likely caused by contaminated porcine trypsin. The event triggered the development of new regulatory guidance on the use of porcine trypsin which shall ensure that cell lines and porcine trypsin in use are free from PCV1. In addition, manufacturing processes of biologicals other than live vaccines include virus clearance steps that may prevent and mitigate any potential virus contamination of product. In this work, artificial spiking of down-scaled models for the manufacturing process of an inactivated pandemic influenza virus vaccine were used to investigate inactivation of PCV1 and the physico-chemically related porcine parvovirus (PPV) by formalin and ultraviolet-C (UV-C) treatment as well as removal by the purification step sucrose gradient ultracentrifugation. A PCV1 infectivity assay, using a real-time PCR infectivity readout was established. The formalin treatment (0.05% for 48h) showed substantial inactivation for both PCV1 and PPV with reduction factors of 3.0log10 and 6.8log10, respectively, whereas UV-C treatment resulted in complete PPV (≥5.9log10) inactivation already at a dose of 13mJ/cm but merely 1.7log10 at 24mJ/cm(2) for PCV1. The UV-C inactivation results with PPV were confirmed using minute virus of mice (MVM), indicating that parvoviruses are far more sensitive to UV-C than PCV1. The sucrose density gradient ultracentrifugation also contributed to PCV1 clearance with a reduction factor of 2log10. The low pH treatment during the production of procine trypsin was investigated and showed effective inactivation for both PCV1 (4.5log10) and PPV (6.4log10). In conclusion, PCV1 in general appears to be more resistant to virus inactivation than PPV. Still, the inactivated pandemic influenza vaccine manufacturing process provides for robust virus reduction, in addition to the already implemented testing for PCV1 to avoid any contaminations.
    MeSH term(s) Acids ; Animals ; Cercopithecus aethiops ; Circovirus ; Drug Contamination/prevention & control ; Formaldehyde ; Hydrogen-Ion Concentration ; Parvovirus, Porcine ; Swine ; Ultracentrifugation ; Ultraviolet Rays ; Vero Cells ; Viral Vaccines/pharmacology ; Virus Inactivation
    Chemical Substances Acids ; Viral Vaccines ; Formaldehyde (1HG84L3525)
    Language English
    Publishing date 2014-04-11
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2014.02.011
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1930: Show issues Location:
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    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 458: Show issues

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  6. Article: Reduction of spiked porcine circovirus during the manufacture of a Vero cell-derived vaccine

    Lackner, Cornelia / Birgit Schäfer / Heinz Anderle / Jens Modrof / Leopold Grillberger / Maria R. Farcet / Sandra M. Leydold / Thomas R. Kreil

    Vaccine. 2014 Apr. 11, v. 32, no. 18

    2014  

    Abstract: Porcine circovirus-1 (PCV1) was recently identified as a contaminant in live Rotavirus vaccines, which was likely caused by contaminated porcine trypsin. The event triggered the development of new regulatory guidance on the use of porcine trypsin which ... ...

    Abstract Porcine circovirus-1 (PCV1) was recently identified as a contaminant in live Rotavirus vaccines, which was likely caused by contaminated porcine trypsin. The event triggered the development of new regulatory guidance on the use of porcine trypsin which shall ensure that cell lines and porcine trypsin in use are free from PCV1. In addition, manufacturing processes of biologicals other than live vaccines include virus clearance steps that may prevent and mitigate any potential virus contamination of product. In this work, artificial spiking of down-scaled models for the manufacturing process of an inactivated pandemic influenza virus vaccine were used to investigate inactivation of PCV1 and the physico-chemically related porcine parvovirus (PPV) by formalin and ultraviolet-C (UV-C) treatment as well as removal by the purification step sucrose gradient ultracentrifugation. A PCV1 infectivity assay, using a real-time PCR infectivity readout was established. The formalin treatment (0.05% for 48h) showed substantial inactivation for both PCV1 and PPV with reduction factors of 3.0log10 and 6.8log10, respectively, whereas UV-C treatment resulted in complete PPV (≥5.9log10) inactivation already at a dose of 13mJ/cm but merely 1.7log10 at 24mJ/cm2 for PCV1. The UV-C inactivation results with PPV were confirmed using minute virus of mice (MVM), indicating that parvoviruses are far more sensitive to UV-C than PCV1. The sucrose density gradient ultracentrifugation also contributed to PCV1 clearance with a reduction factor of 2log10. The low pH treatment during the production of procine trypsin was investigated and showed effective inactivation for both PCV1 (4.5log10) and PPV (6.4log10). In conclusion, PCV1 in general appears to be more resistant to virus inactivation than PPV. Still, the inactivated pandemic influenza vaccine manufacturing process provides for robust virus reduction, in addition to the already implemented testing for PCV1 to avoid any contaminations.
    Keywords formalin ; influenza ; Influenza A virus ; live vaccines ; manufacturing ; models ; pandemic ; pathogenicity ; pH ; Porcine circovirus ; Porcine circovirus-1 ; quantitative polymerase chain reaction ; Rodent protoparvovirus 1 ; Rotavirus ; sucrose ; swine ; trypsin ; ultracentrifugation ; ultraviolet radiation ; Ungulate protoparvovirus 1 ; viruses
    Language English
    Dates of publication 2014-0411
    Size p. 2056-2061.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2014.02.011
    Database NAL-Catalogue (AGRICOLA)

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    Zs.MO 458: Show issues

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