Development of small-scale models to understand the impact of continuous downstream bioprocessing on integrated virus filtration DOI Link Author Scott Lute, Julie Kozaili, et al. Organization U.S. FDA, Asahi Kasei Medical Co., Ltd. Journal Biotechnol Progress Year 2020 Access Open
Microscopic visualization of virus removal by dedicated filters used in biopharmaceutical processing: Impact of membrane structure and localization of captured virus particles DOI Link 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
The Role of Nanofiltration in the Pathogen Safety of Biologicals: An Update DOI Link 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
Inactivation and Removal of Chikungunya Virus and Mayaro Virus from Plasma-derived Medicinal Products DOI Link 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
Use of a noninfectious surrogate to predict minute virus of mice removal during nanofiltration DOI Link Author Cetlin, D., et al Organization MockV Solutions, Inc. Journal Biotechnology Progress 34(5) pp.1113-1220 Year 2018 Access Abstract Only
Inactivation and removal of Zika virus during manufacture of plasma‐derived medicinal products DOI Link Author Blumel, J. et al Organization Paul-Ehrlich-Institut Journal Transfusion 2017 (57) 790-796 Year 2017 Access Open
cGMP production and analysis of BG505 SOSIP.664, an extensively glycosylated, trimeric HIV‐1 envelope glycoprotein vaccine candidate DOI Link 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
Hepatitis E virus derived from different sources exhibits different behaviour in virus inactivation and/or removal studies with plasma derivatives DOI Link Author Yunoki, M., et al Organization Japan Blood Products Organization Journal Biologicals 44(5) 403-411 Year 2016 Access Abstract Only
Pathogen safety of a pasteurized four‐factor human prothrombin complex concentrate preparation using serial 20N virus filtration DOI Link Author Nowak, T., et al Organization CSL Behring Journal Transfusion 57(5) 1184-1191 Year 2017 Access Open
Pathogen Safety of a New Intravenous Immune Globulin 10% Liquid DOI Link Author Radomski, K., et al Organization Octapharma Biopharmaceuticals GmbH Journal BioDrugs (2017) 31: 125 Year 2017 Access Open
Evaluation of the virus clearance capacity and robustness of the manufacturing process for the recombinant factor VIII protein, turoctocog alfa DOI Link Author Ellgaard, T., et al Organization Novo Nordisk A/S Journal Protein Expression and Purification 129 (2017) 94-100 Year 2017 Access Open
Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein DOI Link Author McCue, J., et al Organization Biogen Journal Haemophilia 20(4): e327-e335 Year 2014 Access Open
BAY 81-8973, a full-length recombinant factor VIII: manufacturing processes and product characteristics DOI Link Author Garger, S., et al Organization Bayer Journal Haemophilia 23(2): e67-e78 Year 2017 Access Open
Manufacturing process used to produce long-acting recombinant factor VIII Fc fusion protein DOI Link Author McCue, J., et al Organization Biogen Journal Biologicals 43: 213–219 Year 2015 Access Open
Pathogen safety and characterisation of a highly purified human alpha1-proteinase inhibitor preparation DOI Link Author Kee, S., et al Organization CSL Behring Journal Biologicals 47: 25–32 Year 2017 Access Open
Validation and implementation of Planova™ BioEX virus filters in the manufacture of a new liquid intravenous immunoglobulin in China" DOI Link 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
Characterizing the Impact of Pressure on Virus Filtration Processes and Establishing Design Spaces to Ensure Effective Parvovirus Removal DOI Link Author Strauss, D., et al Organization Asahi Kasei Bioprocess America Journal Biotechnology Process e-pub Year 2017 Access Open
Effect of Hydrodynamic Forces on Virus Removal Capability of Planova™ Filters DOI Link Author Yamamoto, A. et al. Organization Asahi Kasei Corporation Journal AIChE Journal Vol.60, No.6 2286-2297 Year 2014 Access Abstract Only
Improved removal of viruslike particles from purified monoclonal antibody IgM preparation via virus filtration DOI Link 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
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 DOI Link Author Winge, S., et al. Organization Octapharma AB Journal Protein Expression and Purification 115 (2015) 165–175 Year 2015 Access Open
Pathogen safety of intravenous Rh immunoglobulin liquid and other immune globulin products: Enhanced nanofiltration and manufacturing process overview DOI Link 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
Capacity of the manufacturing process of Flebogamma® DIF, a new human high purity intravenous immunoglobulin, to remove a TSE model-agent DOI Link Author Diez, J. M., et al. Organization Instituto Grifols S. A. Journal Biologicals 38: 670-674 Year 2010 Access Abstract Only
Virus removal from Factor IX by filtration: Validation of the integritytest and effect of manufacturing process conditions DOI Link Author Roberts, P. L., et al. Organization Bio Products Laboratory Journal Biologicals 38: 303-31010 Year 2010 Access Abstract Only
Viral safety of C1-inhibitor NF DOI Link 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
Comparison of nanofiltration efficacy in reducing infectivity of centrifuged versus ultracentrifuged 263K scrapie-infected brain homogenates in "spiked" albumin solutions DOI Link 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
Removal of small non-enveloped viruses by nanofiltration DOI Link 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
Nanofiltration, a new specific virus elimination method applied to high-purity Factor IX and Factor XI concentrates DOI Link Author Burnouf-Radosevich, M., et al. Organization Centre Régional de Transfusion Sanguine Journal Vox Sanguinis 67: 132-138 Year 1994 Access Abstract Only
Prion removal by nanofiltration under different experimental conditions DOI Link 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
Manufacturing process of Anti-thrombin III concentrate: viral safety validation studies and effect of column re-use on viral clearance DOI Link 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
Phage passage after extended processing in small-virus-retentive filters DOI Link 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
Large-scale production and properties of human plasma-derived activated Factor VII concentrate DOI Link Author Tomokiyo, K., et al. Organization Kaketsuken Journal Vox Sanguinis 84: 54-64 Year 2003 Access Abstract Only
In vitro study of a triple-secured von Willebrand factor concentrate DOI Link Author Mazurier, C., et al. Organization Laboratoire Francais du Franctionnement et des Biotechnologies Journal Vox Sanguinis 86: 100-104 Year 2004 Access Abstract Only
Implementation of a 20-nm pore-size filter in the plasma-derived Factor VIII manufacturing process DOI Link Author Furuya, K., et al. Organization Japanese Red Cross Plasma Fractionation Center Journal Vox Sanguinis 91: 119-125 Year 2006 Access Abstract Only
Removal of small nonenveloped viruses by antibody-enhanced nanofiltration during the manufacture of plasma derivative DOI Link Author Kreil, T., et al. Organization Baxter BioScience Journal Transfusion 46: 1143-1151 Year 2006 Access Abstract Only
Removal of small viruses (parvovirus) from IgG solution by virus removal filter Planova™ 20N DOI Link Author Hongo, T., et al. Organization Asahi Kasei Medical Co., Ltd. and Yamaguchi University Journal Journal of Membrane Science 278: 3-9 Year 2006 Access Abstract Only
A new liquid intravenous immunoglobulin with three dedicated virus reduction steps: virus and prion reduction capacity DOI Link Author Poelsler, G., et al. Organization Baxter Bioscience Journal Vox Sanguinis 94: 184-192 Year 2008 Access Abstract Only
Flebogamma® 5% DIF development: rationale for a new option in intravenous immunoglobulin therapy DOI Link Author Jorquera, J. I. Organization Institute Grifols S.A. Journal Clinical and Experimental Immunology 157: 17-21 Year 2009 Access Open
Effect of antibody solution conditions on filter performance for virus removal filter Planova™ 20N DOI Link Author Hongo-Hirasaki, T., et al. Organization Asahi Kasei Medical Co., Ltd. Journal Biotechnology Progress 26: 1080-1087 Year 2011 Access Abstract Only
Effects of varying virus-spiking conditions on a virus-removal filter Planova™ 20N in a virus validation study of antibody solutions DOI Link Author Hongo-Hirasaki, T., et al. Organization Asahi Kasei Medical Co., Ltd. Journal Biotechnology Progress 27: 162-169 Year 2011 Access Abstract Only
Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process DOI Link Author Dichtelmuller H. O., et al. Organization Biotest AG and Biotest Pharmaceuticals Journal Results in Immunology 2: 19-24 Year 2012 Access Open
Virus filtration of high-concentration monoclonal antibody solutions DOI Link Author Marques, B., et al. Organization Merck and Co., Inc. Journal Biotechnology Progress 25: 483-491 Year 2009 Access Abstract Only