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41 Results Found

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  1. Development of small-scale models to understand the impact of continuous downstream bioprocessing on integrated virus filtration

    Author
    Scott Lute, Julie Kozaili, et al.
    Organization
    U.S. FDA, Asahi Kasei Medical Co., Ltd.
    Journal
    Biotechnol Progress
    Year
    2020
    Access
    Open
  2. Microscopic visualization of virus removal by dedicated filters used in biopharmaceutical processing: Impact of membrane structure and localization of captured virus particles

    Author
    Adan-Kubo, J., et al.
    Organization
    Japanese Blood Products Organization, Asahi Kasei Medical Co., Ltd.
    Journal
    Biotechnol Progress.2019;35:e2875
    Year
    2019
    Access
    Open
  3. The Role of Nanofiltration in the Pathogen Safety of Biologicals: An Update

    Author
    Inouye, M. and Burnouf, T.
    Organization
    M.I.: Asahi Kasei Medical Co., Ltd., T.B.: Taipei Medical University
    Journal
    Current Nanoscience, 2019, 15, 1-10
    Year
    2019
    Access
    Open
  4. Inactivation and Removal of Chikungunya Virus and Mayaro Virus from Plasma-derived Medicinal Products

    Author
    Yue, C., et al.
    Organization
    Paul-Ehrlich-Institut, Asahi Kasei, Instituto Oswaldo Cruz
    Journal
    Viruses. 2019 Mar; 11(3): 234.
    Year
    2019
    Access
    Open
  5. Use of a noninfectious surrogate to predict minute virus of mice removal during nanofiltration

    Author
    Cetlin, D., et al
    Organization
    MockV Solutions, Inc.
    Journal
    Biotechnology Progress 34(5) pp.1113-1220
    Year
    2018
    Access
    Abstract Only
  6. Inactivation and removal of Zika virus during manufacture of plasma‐derived medicinal products

    Author
    Blumel, J. et al
    Organization
    Paul-Ehrlich-Institut
    Journal
    Transfusion 2017 (57) 790-796
    Year
    2017
    Access
    Open
  7. cGMP production and analysis of BG505 SOSIP.664, an extensively glycosylated, trimeric HIV‐1 envelope glycoprotein vaccine candidate

    Author
    Dey, A., et al
    Organization
    International AIDS Vaccine Initiative, Department of Microbiology and Immunology, et al
    Journal
    Biotechnology and Bioengineering 2018 (115) 885–899
    Year
    2018
    Access
    Open
  8. Hepatitis E virus derived from different sources exhibits different behaviour in virus inactivation and/or removal studies with plasma derivatives

    Author
    Yunoki, M., et al
    Organization
    Japan Blood Products Organization
    Journal
    Biologicals 44(5) 403-411
    Year
    2016
    Access
    Abstract Only
  9. Pathogen safety of a pasteurized four‐factor human prothrombin complex concentrate preparation using serial 20N virus filtration

    Author
    Nowak, T., et al
    Organization
    CSL Behring
    Journal
    Transfusion 57(5) 1184-1191
    Year
    2017
    Access
    Open
  10. Pathogen Safety of a New Intravenous Immune Globulin 10% Liquid

    Author
    Radomski, K., et al
    Organization
    Octapharma Biopharmaceuticals GmbH
    Journal
    BioDrugs (2017) 31: 125
    Year
    2017
    Access
    Open
  11. Evaluation of the virus clearance capacity and robustness of the manufacturing process for the recombinant factor VIII protein, turoctocog alfa

    Author
    Ellgaard, T., et al
    Organization
    Novo Nordisk A/S
    Journal
    Protein Expression and Purification 129 (2017) 94-100
    Year
    2017
    Access
    Open
  12. Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein

    Author
    McCue, J., et al
    Organization
    Biogen
    Journal
    Haemophilia 20(4): e327-e335
    Year
    2014
    Access
    Open
  13. BAY 81-8973, a full-length recombinant factor VIII: manufacturing processes and product characteristics

    Author
    Garger, S., et al
    Organization
    Bayer
    Journal
    Haemophilia 23(2): e67-e78
    Year
    2017
    Access
    Open
  14. Manufacturing process used to produce long-acting recombinant factor VIII Fc fusion protein

    Author
    McCue, J., et al
    Organization
    Biogen
    Journal
    Biologicals 43: 213–219
    Year
    2015
    Access
    Open
  15. Pathogen safety and characterisation of a highly purified human alpha1-proteinase inhibitor preparation

    Author
    Kee, S., et al
    Organization
    CSL Behring
    Journal
    Biologicals 47: 25–32
    Year
    2017
    Access
    Open
  16. Validation and implementation of Planova™ BioEX virus filters in the manufacture of a new liquid intravenous immunoglobulin in China"

    Author
    Ma, S., et al.
    Organization
    Shandong Taibang Biological Products Co., Ltd. and Asahi Kasei Medical Co., Ltd.
    Journal
    Biologicals 52 (2018) 37-43
    Year
    2018
    Access
    Abstract Only
  17. Characterizing the Impact of Pressure on Virus Filtration Processes and Establishing Design Spaces to Ensure Effective Parvovirus Removal

    Author
    Strauss, D., et al
    Organization
    Asahi Kasei Bioprocess America
    Journal
    Biotechnology Process e-pub
    Year
    2017
    Access
    Open
  18. Effect of Hydrodynamic Forces on Virus Removal Capability of Planova™ Filters

    Author
    Yamamoto, A. et al.
    Organization
    Asahi Kasei Corporation
    Journal
    AIChE Journal Vol.60, No.6 2286-2297
    Year
    2014
    Access
    Abstract Only
  19. Improved removal of viruslike particles from purified monoclonal antibody IgM preparation via virus filtration

    Author
    Maerz, H., et al.
    Organization
    University of Leipzig, Humboldt-University/Charite, Dr. Fooke Laboratorien GmbH, and Asahi Chemical Industries
    Journal
    Nature Biotechnology 14: 651-652
    Year
    1996
    Access
    No Abstract
  20. Development, upscaling and validation of the purification process for human-cl rhFVIII (Nuwiq), a new generation recombinant factor VIII produced in a human cell-line

    Author
    Winge, S., et al.
    Organization
    Octapharma AB
    Journal
    Protein Expression and Purification 115 (2015) 165–175
    Year
    2015
    Access
    Open
  21. Pathogen safety of intravenous Rh immunoglobulin liquid and other immune globulin products: Enhanced nanofiltration and manufacturing process overview

    Author
    Soluk, L., et al
    Organization
    Cangene Corporation and Baxter Healthcare Corporation
    Journal
    American Journal of Therapeutics 15: 435-443
    Year
    2008
    Access
    Abstract Only
  22. Capacity of the manufacturing process of Flebogamma® DIF, a new human high purity intravenous immunoglobulin, to remove a TSE model-agent

    Author
    Diez, J. M., et al.
    Organization
    Instituto Grifols S. A.
    Journal
    Biologicals 38: 670-674
    Year
    2010
    Access
    Abstract Only
  23. Virus removal from Factor IX by filtration: Validation of the integritytest and effect of manufacturing process conditions

    Author
    Roberts, P. L., et al.
    Organization
    Bio Products Laboratory
    Journal
    Biologicals 38: 303-31010
    Year
    2010
    Access
    Abstract Only
  24. Viral safety of C1-inhibitor NF

    Author
    Terpstra, F. G., et al.
    Organization
    Sanquin Research and Landsteiner Laboratory of the Academic Medical Center of the University of Amsterdam and Sanquin Plasma Products
    Journal
    Biologicals 35: 173-181
    Year
    2007
    Access
    Abstract Only
  25. Comparison of nanofiltration efficacy in reducing infectivity of centrifuged versus ultracentrifuged 263K scrapie-infected brain homogenates in "spiked" albumin solutions

    Author
    Cardone, F., et al.
    Organization
    Istituto Superiore di Sanità, CEA/DSV/iMETI/SEPIA and LFB
    Journal
    Transfusion 52: 953–962
    Year
    2012
    Access
    Abstract Only
  26. Removal of small non-enveloped viruses by nanofiltration

    Author
    Yokoyama, T., et al.
    Organization
    Japanese Red Cross and Sapporo Medical University School of Medicine & Department of Microbiology
    Journal
    Vox Sanguinis 86: 225–229
    Year
    2004
    Access
    Abstract Only
  27. Nanofiltration, a new specific virus elimination method applied to high-purity Factor IX and Factor XI concentrates

    Author
    Burnouf-Radosevich, M., et al.
    Organization
    Centre Régional de Transfusion Sanguine
    Journal
    Vox Sanguinis 67: 132-138
    Year
    1994
    Access
    Abstract Only
  28. Prion removal by nanofiltration under different experimental conditions

    Author
    Yunoki, M., et al.
    Organization
    Osaka University, Benesis Corporation, Mitsubishi Pharma Corporation, and Invitrogen BioServices
    Journal
    Biologicals 36: 27-36
    Year
    2008
    Access
    Abstract Only
  29. Manufacturing process of Anti-thrombin III concentrate: viral safety validation studies and effect of column re-use on viral clearance

    Author
    Morrica, A., et al.
    Organization
    Kedrion S.p.A. and Q-ONE Biotech Ltd
    Journal
    Biologicals 31: 165-173
    Year
    2003
    Access
    Abstract Only
  30. Phage passage after extended processing in small-virus-retentive filters

    Author
    Lute, S., et al.
    Organization
    Food and Drug Administration and Eli Lilly and Company
    Journal
    Biotechnol. Appl. Biochem. 47: 141-151
    Year
    2007
    Access
    Abstract Only