Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD |
| |
| Institution: | 1. Engineering Research Center of Optical Instrument and System, Ministry of Education, Shanghai Key Lab of Modern Optical System, Univesity of Shanghai for Science and Technology, No. 516 Jungong Road, Shanghai 200093, China;2. Institute for Biomedical Engineering, Consolidated Research Institute for Advanced Science and Medical Care (ASMeW), Waseda University, 513 Wasedatsurumaki-cho, Shinjuku-ku, Tokyo 162-0041, Japan;3. Photonics Advanced Research Center, Graduate School of Engineering, Osaka University, Yamadaoka Suita-city, Osaka 565-0871, Japan;1. Department of Cellular and Molecular Biotechnology, Institute of Biotechnology, Urmia University, Urmia, Iran;2. Department of Histology and Embryology, Faculty of Science, Urmia University, Urmia, Iran;3. Department of Molecular Genetics, National Institute of Genetic Engineering and Biotechnology, Tehran, Iran;4. Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran;5. Department of Microbiology, Faculty of Veterinary Medicine, Urmia University, Urmia, Iran;6. Department of Immunology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran;1. Laboratory of Structural Chemistry, Department of Applied Chemistry, College of Engineering, Kyungpook National University, Daegu, 41566, South Korea;2. Department of Physics, College of Natural Science, Kyungpook National University, Daegu, 41566, South Korea;3. Department of Chemistry, University of Hawaii, 2545 The Mall, Honolulu, HI, 96822, United States;1. Reference Center for Thrombotic Microangiopathies, Assistance Publique des Hôpitaux de Paris, Paris, France;2. Institut National de la Transfusion Sanguine, Paris, France;3. Faculty of Medicine of Saint-Etienne, University of Lyon, Saint-Etienne, France;4. University Hospitals of Strasbourg, Strasbourg, France;5. Université de Strasbourg, INSERM U_S1113/IRFaC, Strasbourg, France;6. Centre Hospitalier Emile-Muller, Mulhouse, France;7. Cerus Corporation, Concord, CA, United States;8. Service d’Hématologie biologique, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Paris, France;9. Cerus Europe, Amersfoort, the Netherlands;10. Service d’Hématologie, Hôpital Saint-Antoine, Assistance Publique des Hôpitaux de Paris, Paris, France;11. Sorbonne Universités, Paris, France |
| |
| Abstract: | Nanofiltration is incorporated into the manufacturing processes of many protein biopharmaceuticals to enhance safety by providing the capacity to retain pathogens while allowing protein drugs to pass through the filter. Retention is mainly a function of size; however, the shape of the pathogen may also influence retention. The ability of the Viresolve® Pro nanofilter to remove different sized viruses during the manufacture of a Coagulation Factor IX (Alphanine® SD) was studied at varying ionic strength, a process condition with the potential to affect virus shape and, hence, virus retention. Eight viruses were tested in a scale-down of the nanofiltration process. Five of the viruses (EMCV, Reo, BVDV, HIV, PRV) were nanofiltered at normal sodium processing conditions and three (PPV, HAV and WNV) were nanofiltered at higher and lower sodium. Representative Reduction Factors for all viruses were ≥4.50 logs and removal was consistent over a wide range of ionic strength. |
| |
| Keywords: | Viral safety Nanofiltration Factor IX Ion strength Virus removal |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
