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Article ; Online: Orthopox viruses and the safety margins of solvent-detergent treated plasma-derived medicinal products.

Kindermann, Johanna / Karbiener, Michael / Kreil, Thomas R

2022 Volume 62, Issue 12, Page(s) 2454–2457

Abstract: Background: The currently ongoing outbreak of monkeypox virus in many non-endemic countries around the world has also raised concerns about the safety of plasma-derived medicinal products. Based on what is known about the poxviridae, that is, that ... ...

Abstract	Background: The currently ongoing outbreak of monkeypox virus in many non-endemic countries around the world has also raised concerns about the safety of plasma-derived medicinal products. Based on what is known about the poxviridae, that is, that members are exceedingly large and carry a lipid envelope, effective removal and inactivation by plasma product manufacturing processes is expected. For the widely used solvent-detergent (S/D) treatments, however, poxviruses have been reported as potentially being a bit more resistant. Study design and methods: Using a S/D mixture comprising tri-n-butyl-phosphate, polysorbate 80 and Triton X-100 (TX-100), inactivation of vaccinia virus (a model closely resembling monkeypox virus, both within the same genus, i.e., Orthopoxvirus) in a plasma-derived process intermediate was analyzed over 60 min. As use of Triton X-100 will, based on environmental concerns, be restricted, similar experiments were conducted with a physicochemically virtually identical alternative, Nereid. Results: Fast inactivation of vaccinia virus to the assay detection limit, that is, reduction of infectivity by greater than 4 log Conclusion: As for other lipid-enveloped viruses, treatment of process intermediates with S/D mixtures containing TX-100 or the closely related detergent Nereid are highly effective in inactivating poxviruses. Thus, the current spread of monkeypox virus does not compromise the viral safety margins of plasma-derived medicines.
MeSH term(s)	Humans ; Solvents ; Viruses ; Lipids
Chemical Substances	Solvents ; Lipids
Language	English
Publishing date	2022-09-22
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.17131
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Article ; Online: Prevention and treatment of COVID-19 by mono- and poly-clonal antibodies.

McIntosh, David / Burnouf, Thierry / Karbiener, Michael / Farcet, Maria R / Kreil, Thomas R

Blood transfusion = Trasfusione del sangue

2023 Volume 21, Issue 5, Page(s) 375–377

MeSH term(s)	Humans ; COVID-19/prevention & control ; COVID-19/therapy ; Antibodies, Monoclonal/therapeutic use
Chemical Substances	Antibodies, Monoclonal
Language	English
Publishing date	2023-02-24
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2135732-8
ISSN	2385-2070 ; 0041-1787 ; 1723-2007
ISSN (online)	2385-2070
ISSN	0041-1787 ; 1723-2007
DOI	10.2450/BloodTransfus.436
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Article ; Online: Detergent-Mediated Virus Inactivation in Biotechnological Matrices: More than Just CMC.

Farcet, Jean-Baptiste / Karbiener, Michael / Zelger, Leonhard / Kindermann, Johanna / Kreil, Thomas R

International journal of molecular sciences

2023 Volume 24, Issue 9

Abstract: For decades, the ability of detergents to solubilize biological membranes has been utilized in biotechnological manufacturing to disrupt the lipid envelope of potentially contaminating viruses and thus enhance the safety margins of plasma- and cell- ... ...

Abstract	For decades, the ability of detergents to solubilize biological membranes has been utilized in biotechnological manufacturing to disrupt the lipid envelope of potentially contaminating viruses and thus enhance the safety margins of plasma- and cell-derived drugs. This ability has been linked to detergent micelles, which are formed if the concentration of detergent molecules exceeds the critical micelle concentration (CMC). Traditionally, the CMC of detergents is determined in deionized water (ddH
MeSH term(s)	Detergents/pharmacology ; Micelles ; Virus Inactivation ; Octoxynol/pharmacology ; Viruses
Chemical Substances	Detergents ; Micelles ; polyethylene glycol monooctylphenyl ether ; Octoxynol (9002-93-1)
Language	English
Publishing date	2023-04-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms24097920
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Article: Function matters: Coronavirus cross-binding antibodies do not cross-neutralize.

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

Frontiers in medicine

2022 Volume 9, Page(s) 924426

Abstract: Background: During the current pandemic, the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralization capacity of the immunoglobulin (IG) supply has changed from undetectable for lots manufactured from plasma collected before the ... ...

Abstract	Background: During the current pandemic, the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralization capacity of the immunoglobulin (IG) supply has changed from undetectable for lots manufactured from plasma collected before the pandemic, to now highly potent. Objective: As antibodies induced by exposure to or vaccination against coronaviruses were shown to be cross-coronavirus reactive, it was of interest to understand whether SARS-CoV-2 neutralizing antibodies would result in increased functional IG potency also against seasonal coronaviruses. Methods: IG lots from US plasma collected before SARS-CoV-2 emerged and collected during the pandemic were analyzed by live virus neutralization assay for SARS-CoV-2 and seasonal human coronaviruses (HCoVs) NL63 and OC43 neutralizing antibody content. Results: Pre-pandemic IG showed no SARS-CoV-2 neutralizing antibody titers. However, IG lots produced from plasma of post-coronavirus disease 2019 (COVID-19) individuals exhibited robust anti-SARS-CoV-2 potency (1,267 IU/ml) which further increased ~4-fold in pandemic IG lots reaching a mean titer of 5,122 IU/ml. Nonetheless, neutralizing antibody potencies to the HCoVs NL63 and OC43 remained stable over this period, i.e., have not increased correspondingly. Conclusion: The present results show that cross-coronavirus-reactive antibodies are not cross-neutralizing, i.e., SARS-CoV-2 antibodies do not neutralize seasonal coronaviruses NL63 and OC43.
Language	English
Publishing date	2022-08-02
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2022.924426
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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
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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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Article ; Online: Introducing a new type of alternative laryngeal mucosa model.

Grossmann, Tanja / Kirsch, Andrijana / Grill, Magdalena / Steffan, Barbara / Karbiener, Michael / Brcic, Luka / Darnhofer, Barbara / Birner-Gruenberger, Ruth / Gugatschka, Markus

PloS one

2023 Volume 18, Issue 6, Page(s) e0287634

Abstract: Research of human vocal fold (VF) biology is hampered by several factors. The sensitive microstructure of the VF mucosa is one of them and limits the in vivo research, as biopsies carry a very high risk of scarring. A laryngeal organotypic model ... ...

Abstract	Research of human vocal fold (VF) biology is hampered by several factors. The sensitive microstructure of the VF mucosa is one of them and limits the in vivo research, as biopsies carry a very high risk of scarring. A laryngeal organotypic model consisting of VF epithelial cells and VF fibroblasts (VFF) may overcome some of these limitations. In contrast to human VFF, which are available in several forms, availability of VF epithelial cells is scarce. Buccal mucosa might be a good alternative source for epithelial cells, as it is easily accessible, and biopsies heal without scarring. For this project, we thus generated alternative constructs consisting of immortalized human VF fibroblasts and primary human buccal epithelial cells. The constructs (n = 3) were compared to native laryngeal mucosa at the histological and proteomic level. The engineered constructs reassembled into a mucosa-like structure after a cultivation period of 35 days. Immunohistochemical staining confirmed a multi-layered stratified epithelium, a collagen type IV positive barrier-like structure resembling the basement membrane, and an underlying layer containing VFF. Proteomic analysis resulted in a total number of 1961 identified and quantified proteins. Of these, 83.8% were detected in both native VF and constructs, with only 53 proteins having significantly different abundance. 15.3% of detected proteins were identified in native VF mucosa only, most likely due to endothelial, immune and muscle cells within the VF samples, while 0.9% were found only in the constructs. Based on easily available cell sources, we demonstrate that our laryngeal mucosa model shares many characteristics with native VF mucosa. It provides an alternative and reproducible in vitro model and offers many research opportunities ranging from the study of VF biology to the testing of interventions (e.g. drug testing).
MeSH term(s)	Humans ; Laryngeal Mucosa ; Cicatrix ; Proteomics ; Larynx ; Epithelium
Language	English
Publishing date	2023-06-30
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0287634
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Article ; Online: Detergent-Mediated Virus Inactivation in Biotechnological Matrices

Jean-Baptiste Farcet / Michael Karbiener / Leonhard Zelger / Johanna Kindermann / Thomas R. Kreil

International Journal of Molecular Sciences, Vol 24, Iss 7920, p

More than Just CMC

2023 Volume 7920

Abstract	For decades, the ability of detergents to solubilize biological membranes has been utilized in biotechnological manufacturing to disrupt the lipid envelope of potentially contaminating viruses and thus enhance the safety margins of plasma- and cell-derived drugs. This ability has been linked to detergent micelles, which are formed if the concentration of detergent molecules exceeds the critical micelle concentration (CMC). Traditionally, the CMC of detergents is determined in deionized water (ddH 2 O), i.e., a situation considerably different from the actual situation of biotechnological manufacturing. This study compared, for five distinct detergents, the CMC in ddH 2 O side-by-side with two biopharmaceutical process intermediates relevant to plasma-derived (Immunoglobulin) and cell-derived (monoclonal antibody) products, respectively. Depending on the matrix, the CMC of detergents changed by a factor of up to ~4-fold. Further, the CMC in biotechnological matrices did not correlate with antiviral potency, as Triton X-100 (TX-100) and similar detergents had comparatively higher CMCs than polysorbate-based detergents, which are known to be less potent in terms of virus inactivation. Finally, it was demonstrated that TX-100 and similar detergents also have virus-inactivating properties if applied below the CMC. Thus, the presence of detergent micelles might not be an absolute prerequisite for the disruption of virus envelopes.
Keywords	virus inactivation ; Triton X-100 ; detergent ; Nereid ; Triton X-100 reduced ; CMC ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Subject code	500
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
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Article ; Online: Function matters

Maria R. Farcet / Julia Schwaiger / Michael Karbiener / Thomas R. Kreil

Frontiers in Medicine, Vol

Coronavirus cross-binding antibodies do not cross-neutralize

2022 Volume 9

Abstract: BackgroundDuring the current pandemic, the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralization capacity of the immunoglobulin (IG) supply has changed from undetectable for lots manufactured from plasma collected before the ... ...

Abstract	BackgroundDuring the current pandemic, the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralization capacity of the immunoglobulin (IG) supply has changed from undetectable for lots manufactured from plasma collected before the pandemic, to now highly potent.ObjectiveAs antibodies induced by exposure to or vaccination against coronaviruses were shown to be cross-coronavirus reactive, it was of interest to understand whether SARS-CoV-2 neutralizing antibodies would result in increased functional IG potency also against seasonal coronaviruses.MethodsIG lots from US plasma collected before SARS-CoV-2 emerged and collected during the pandemic were analyzed by live virus neutralization assay for SARS-CoV-2 and seasonal human coronaviruses (HCoVs) NL63 and OC43 neutralizing antibody content.ResultsPre-pandemic IG showed no SARS-CoV-2 neutralizing antibody titers. However, IG lots produced from plasma of post-coronavirus disease 2019 (COVID-19) individuals exhibited robust anti-SARS-CoV-2 potency (1,267 IU/ml) which further increased ~4-fold in pandemic IG lots reaching a mean titer of 5,122 IU/ml. Nonetheless, neutralizing antibody potencies to the HCoVs NL63 and OC43 remained stable over this period, i.e., have not increased correspondingly.ConclusionThe present results show that cross-coronavirus-reactive antibodies are not cross-neutralizing, i.e., SARS-CoV-2 antibodies do not neutralize seasonal coronaviruses NL63 and OC43.
Keywords	immune deficiency ; neutralizing antibodies ; COVID-19 ; intravenous immunoglobulin ; immunoglobulin ; plasma ; Medicine (General) ; R5-920
Subject code	572
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
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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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