Viral contamination in biologic manufacture and implications for emerging therapies von Barone, Paul W., Wiebe, Michael E., Leung, James C., Hussein, Islam T. M., Keumurian, Flora J., Bouressa, James, Brussel, Audrey, Chen, Dayue, Chong, Ming, Dehghani, Houman, Gerentes, Lionel, Gilbert, James, Gold, Dan, Kiss, Robert, Kreil, Thomas R., Labatut, René, Li, Yuling, Müllberg, Jürgen, Mallet, Laurent, Menzel, Christian, Moody, Mark, Monpoeho, Serge, Murphy, Marie, Plavsic, Mark, Roth, Nathan J., Roush, David, Ruffing, Michael, Schicho, Richard, Snyder, Richard, Stark, Daniel, Zhang, Chun, Wolfrum, Jacqueline, Sinskey, Anthony J., Springs, Stacy L.

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Modelling the concentration of anti-SARS-CoV-2 immunoglobulin G in intravenous immunoglobulin product batches von Stinca, Sara, Barnes, Thomas W., Vogel, Peter, Meyers, Wilfried, Schulte-Pelkum, Johannes, Filchtinski, Daniel, Steller, Laura, Hauser, Thomas, Manni, Sandro, Gardiner, David F., Popik, Sharon, Roth, Nathan J., Schuetz, Patrick

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Effective inactivation of a wide range of viruses by pasteurization von Gröner, Albrecht, Broumis, Connie, Fang, Randel, Nowak, Thomas, Popp, Birgit, Schäfer, Wolfram, Roth, Nathan J.

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Hepatitis A Virus Incidence Rates and Biomarker Dynamics for Plasma Donors, United States von Schoch, Stephanie, Walti, Martin, Schemmerer, Mathias, Alexander, Rick, Keiner, Bjoern, Kralicek, Carol, Bycholski, Keith, Hyatt, Kelley, Knowles, Jon, Klochkov, Denis, Simon, Toby, Wenzel, Juergen J., Roth, Nathan J., Widmer, Eleonora

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Robustness of nanofiltration for increasing the viral safety margin of biological products von Caballero, Santiago, Diez, José M., Belda, Francisco J., Otegui, Magdalena, Herring, Steven, Roth, Nathan J., Lee, Douglas, Gajardo, Rodrigo, Jorquera, Juan I.

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Impact of the isoelectric point of model parvoviruses on viral retention in anion‐exchange chromatography von Leisi, Remo, Wolfisberg, Raphael, Nowak, Thomas, Caliaro, Oliver, Hemmerle, Andreas, Roth, Nathan J., Ros, Carlos

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Choice of parvovirus model for validation studies influences the interpretation of the effectiveness of a virus filtration step von Nowak, Thomas, Popp, Birgit, Roth, Nathan J.

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Low hepatitis E virus RNA prevalence in a large‐scale survey of United States source plasma donors von Roth, Nathan J., Schäfer, Wolfram, Alexander, Rick, Elliott, Kevin, Elliott‐Browne, Wlenyeno, Knowles, Jonathan, Wenzel, Jürgen J., Simon, Toby L.

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Manufacturing of plasma-derived C1-inhibitor concentrate for treatment of patients with hereditary angioedema von Simon, Toby L., Kalina, Uwe, Laske, Reiner, Mycroft, Sarah, Widmer, Eleonora, Roth, Nathan J.

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Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection from Plasma Protein Therapeutics Asso... von Dichtelmüller, Herbert O., Biesert, Lothar, Fabbrizzi, Fabrizio, Falbo, Anna, Flechsig, Eckhard, Gröner, Albrecht, von Hoegen, Ilka, Kempf, Christoph, Kreil, Thomas R., Lee, Douglas C., Pölsler, Gerhard, Roth, Nathan J.

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Nanofiltration as a robust method contributing to viral safety of plasma‐derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers von Roth, Nathan J., Dichtelmüller, Herbert O., Fabbrizzi, Fabrizio, Flechsig, Eckhard, Gröner, Albrecht, Gustafson, Mary, Jorquera, Juan I., Kreil, Thomas R., Misztela, Dominika, Moretti, Elisa, Moscardini, Mila, Poelsler, Gerhard, More, John, Roberts, Peter, Wieser, Andreas, Gajardo, Rodrigo

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Characterization of a quasi-enveloped, fast replicating hepevirus from fish and its use as hepatitis E virus surrogate von Bochud, Maëlle, Schäfer, Wolfram, Roth, Nathan J., Ros, Carlos

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Effective coronavirus reduction by various production steps during the manufacture of plasma‐derived medicinal products von Schräder, Tobias, Koch, Julia, Ross, Rachael, Schäfer, Wolfram, Keiner, Björn, Roth, Nathan J., Widmer, Eleonora

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Analysis of 52 240 source plasma donors of convalescent COVID‐19 plasma: Sex, ethnicity, and age association with initial antibody levels and rate of dissipation von Schmidt, Amy E., Vogel, Peter, Chastain, Carrie A., Barnes, Thomas, Roth, Nathan J., Simon, Toby L.

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Determination of neutralising anti-SARS-CoV-2 antibody half-life in COVID-19 convalescent donors von Barnes, Thomas W., Schulte-Pelkum, Johannes, Steller, Laura, Filchtinski, Daniel, Jenness, Robin, Williams, Michelle R., Kober, Christina, Manni, Sandro, Hauser, Thomas, Hahn, Aaron, Kalina, Uwe, Simon, Toby L., Schuetz, Patrick, Roth, Nathan J.

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Hepatitis E virus: Efficacy of pasteurization of plasma‐derived VWF/FVIII concentrate determined by pig bioassay von Dähnert, Lisa, Schlosser, Josephine, Fast, Christine, Fröhlich, Andreas, Gröner, Albrecht, Lange, Elke, Roth, Nathan J., Schäfer, Wolfram, Schröder, Charlotte, Eiden, Martin, Groschup, Martin H.

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Prion removal capacity of plasma protein manufacturing processes von Cai, Kang, Gröner, Albrecht, Dichtelmüller, Herbert O., Fabbrizzi, Fabrizio, Flechsig, Eckhard, Gajardo, Rodrigo, von Hoegen, Ilka, Jorquera, Juan I., Kempf, Christoph, Kreil, Thomas R., Lee, Douglas C., Moscardini, Mila, Pölsler, Gerhard, Roth, Nathan J.

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Verification of effective Zika virus reduction by production steps used in the manufacture of plasma‐derived medicinal products von Roth, Nathan J., Schäfer, Wolfram, Popp, Birgit, Stucki, Martin, Fang, Randel

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Pathogen safety of a pasteurized four‐factor human prothrombin complex concentrate preparation using serial 20N virus filtration von Nowak, Thomas, Popp, Birgit, Gröner, Albrecht, Schäfer, Wolfram, Kalina, Uwe, Enssle, Karlheinz, Roth, Nathan J.

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Pathogen safety and characterisation of a highly purified human alpha1-proteinase inhibitor preparation von Kee, Scott, Weber, David, Popp, Birgit, Nowak, Thomas, Schäfer, Wolfram, Gröner, Albrecht, Roth, Nathan J.

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