1 |
H. Brough, C. Antoniou, J. Carter, J. Jakubik, Y. Xu, and H. Lutz, "Performance of a novel viresolve NFR virus filter", Biotechnol. Prog., 18, 782 (2002).
DOI
|
2 |
https://www.merckmillipore.com/KR/ko/, February 25 (2020).
|
3 |
K. Tarrach, A. Meyer, J. E. Dathe, and H. Sun, "The effect of flux decay on a 20 nm nanofilter for virus retention", Biopharm Int., 20, 58 (2007).
|
4 |
https://www.sartorius.com, February 25 (2020).
|
5 |
S. Emory, "Principles of integrity testing hydrophilic microporous membranes", Pharm. Technol., 13, 68 (1989).
|
6 |
A. Depalma, "Making Filtration Work", Bioprocess Int., 17, 4 (2019).
|
7 |
J. Bartels, A. G. Batista, S. Kroll, M. Maas, and K. Rezwan, "Hydrophobic ceramic capillary membranes for versatile virus filtration", J. Membr. Sci., 570-571, 85 (2019).
DOI
|
8 |
"Regulations on Product Approval and Examination of Biological Products", MFDS (2019).
|
9 |
"Overview of Biological Products", FDA (CDER) (2013).
|
10 |
"Biopharmaceutical Industry Trend Report", KoBIA (2018).
|
11 |
D. B. Yim, "Biopharmaceutical Market Opportunity and Global Competitiveness", Samjong KPMG ERI Co., 59 (2016).
|
12 |
P. Roberts, "Virus safety in bio products", J. Chem. Technol. Biotechnol., 59(1), 110 (1994).
DOI
|
13 |
"Points to consider in the manufacture and testing of monoclonal antibody products for human use, department of health and human services", FDA (CBER) (1996).
|
14 |
"Guidance for industry: Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin", ICH (1999).
|
15 |
M. Bakhshayeshirad, "Performance characteristics of virus filtration membranes: Protein fouling and virus retention", Penn State Univ. (2011).
|
16 |
S. Liu, M. Carroll, R. Iverson, C. Valera, J. Vennari, K. Turco, R. Piper, R. Kiss, and H. Lutz, "Development and qualification of a novel virus removal filter for cell culture applications", Biotechnol. Prog., 16, 425 (2000).
DOI
|
17 |
"Guideline on validation of biopharmaceuticals manufacture processes", MFDS (2016).
|
18 |
A. S. Rathore and A. Shirke, "Recent developments in membrane-based separations in biotechnology processes: Review", Prep. Biochem. Biotechnol., 41, 398 (2011).
DOI
|
19 |
A. A. Shukla, M. R. Etzel, and S. Gadam, "Process Scale Bioseparation for the Biopharmaceutical Industry", Taylor & Francis, New York, NY, 297 (2007).
|
20 |
W. P. Olson, "Separations Technology: Pharmaceutical and Biotechnology Applications", Interpharm Press, Buffalo Grove, IL, 122 (1995).
|
21 |
R. V. Reis and A. Zydney, "Bioprocess membrane technology", J. Membr. Sci., 297, 16 (2007).
DOI
|
22 |
M. A. Serabian and A. M. Pilaro, "Safety assessment of biotechnology -derived pharmaceuticals: ICH and beyond", Toxicol. Pathol., 27, 27 (1999).
DOI
|
23 |
A. S. Rosenberg, "Effects of protein aggregates: An immunologic perspective", AAPS J., 8, 501 (2006).
DOI
|
24 |
"Guideline on assessing virus stability of biotechnology products from cell lines", MFDS (2002).
|
25 |
D. Gail, "QA/QC for viral clearance", Genetic Engineering & Biotechnology News (www.genengnews.com), 26 (2006).
|
26 |
S. Chandra, A. Groener, and F. Feldman, "Effectiveness of alternative treatments for reducing potential viral contaminants from plasma-derived products", Thromb Res., 105, 391 (2002).
DOI
|
27 |
P. Roberts, "Resistance of vaccinia virus to inactivation by solvent/detergent treatment of blood products", Biologicals, 28, 29 (2000).
DOI
|
28 |
J. L. Lundblad and R. L. Seng, "Inactivation of lipid-enveloped viruses in proteins by caprylate", Vox Sang., 60, 75 (1991).
DOI
|
29 |
F. Brown, "An overview of the inactivation of FMDV and the implications when residual virus is present in vaccines", Dev. Biol. Stand., 75, 37 (1991).
|
30 |
M. F. Bachmann, T. M. Kundig, C. P. Kalberer, H. Hengartner, and R. M. Zinkernagel, "Formalin inactivation of vesicular stomatitis virus impairs T-cell but not T-help-independent B-cell responses", J. Virol., 67, 3917 (1993).
DOI
|
31 |
A. Scheidler, K. Rokos, T. Reuter, R. Ebermann, and G. Pauli, "Inactivation of viruses by beta-propiolactone in human cryo poor plasma and IgG concentrates", Biologicals, 26, 135 (1998).
DOI
|
32 |
W. R. Alonso, S. Trukawinski, M. Savage, R. A. Tenold, and D. J. Hammond, "Viral inactivation of intramuscular immune serum globulins", Biologicals, 28, 5 (2000).
DOI
|
33 |
S. A. Lawrence, "Beta-propiolactone: Viral inactivation in vaccines and plasma products", PDA J. Pharm. Sci. Technol., 54, 209 (2000).
|
34 |
M. Korneyeva, J. Hotta, W. Lebing, R. S. Rosenthal, L. Franks, and S. R. Petteway Jr, "Enveloped virus inactivation by caprylate: A robust alternative to solvent-detergent treatment in plasma derived intermediates", Biologicals, 30, 153 (2002).
DOI
|
35 |
H. Dichtelmuller, D. Rudnick, and M. Kloft, "Inactivation of lipid enveloped viruses by octanoic acid treatment of immunoglobulin solution", Biologicals, 30, 135 (2002).
DOI
|
36 |
Parenteral Drug Association (PDA), "PDA Technical Report No. 41: Virus filtration", PDA J. Pharm. Sci. Technol., 59 (2005).
|
37 |
M. Azari, J. A. Boose, K. E. Burhop, T. Camacho, J. Catarello, A. Darling, A. A. Ebeling, T. N. Estep, L. Pearson, S. Guzder, J. Herren, K. Ogle, J. Paine, K. Rohn, R. Sarajari, C. S. Sun, and L. Zhang, "Evaluation and validation of virus removal by ultrafiltration during the production of diaspirin crosslinked haemoglobin (DCLHb)", Biologicals, 28, 81 (2000).
DOI
|
38 |
T. Urase, K. Yamamoto, and S. Ohgaki, "Effect of pore structure of membranes and module configuration on virus retention", J. Membr. Sci., 115, 21 (1996).
DOI
|
39 |
K. Furuya, K. Murai, T. Yokoyama, H. Maeno, Y. Takeda, T. Murozuka, A. Wakisaka, M. Tanifuji and T. Tomono, "Implementation of a 20-nm pore-size filter in the plasma-derived Factor VIII manufacturing process", Vox Sang., 91, 119 (2006).
DOI
|
40 |
I. Laursen, G. Houen, P. Hojrup, N. Brouwer, L. B. Krogsoe, L. Blou, and P. R. Hansen, "Second-generation nanofiltered plasma-derived mannan-binding lectin product: Process and characteristics", Vox Sang., 92, 338 (2007).
DOI
|
41 |
T. R. Kreil, A. Wieser, A. Berting, M. Spruth, C. Medek, G. Pölsler, T. Gaida, T. Hämmerle, W. Teschner, H. P. Schwarz, and P. N. Barrett, "Removal of small nonenveloped viruses by antibody-enhanced nanofiltration during the manufacture of plasma derivatives", Transfusion, 46, 1143 (2006).
DOI
|
42 |
T. Burnouf and M. Radosevich, "Nanofiltration of plasma-derived biopharmaceutical products", Haemophilia, 9, 24 (2003).
DOI
|
43 |
A. Johnston, A. MacGregor, S. Borovec, M. Hattarki, K. Stuckly, D. Anderson, N. H. Goss, A. Oates, and E. Uren, "Inactivation and clearance of viruses during the manufacture of high purity factor IX", Biologicals, 28, 129 (2000).
DOI
|
44 |
K. H. Oshima, T. T. Evans-Strickfaden, and A. K. Highsmith, "Comparison of filtration properties of hepatitis B virus, hepatitis C virus and simian virus 40 using a polyvinylidene fluoride membrane filter", Vox Sang., 75, 181 (1998).
DOI
|
45 |
https://planova.ak-bio.com, February 25 (2020).
|
46 |
K. H. Oshima, T. W. Comans, A. K. Highsmith, and E. W. Ades, "Removal of human immunodeficiency virus by an 0.04-micron membrane filter", J. Acquir. Immune Defic. Syndr. Hum. Retrovirol., 8, 64 (1995).
|
47 |
K. H. Oshima, "Evans-Strickfaden T. T., Highsmith A. K., Ades E. W., The use of a microporous polyvinylidene fluoride (PVDF) membrane filter to separate contaminating viral particles from biologically important proteins", Biologicals, 24, 137 (1996).
DOI
|
48 |
H. Aranha-Creado, K. Oshima, S. Jafari, G. Howard, and H. Brandwein, "Virus retention by a hydrophilic triple-layer PVDF microporous membrane filter", PDA J. Pharm. Sci. Technol., 51, 119 (1997).
|
49 |
H. Aranha-Creado, J. Peterson, and P. Y. Huang, "Clearance of murine leukaemia virus from monoclonal antibody solution by a hydrophilic PVDF microporous membrane filter", Biologicals, 26, 167 (1998).
DOI
|
50 |
G. Miesegaes, S. Lute, H. Aranha, and K. Brorson, "Virus retentive filters", in: M. C. Flickinger(Ed.), Encyclopedia of Industrial Biotechnology, Bioprocess, Bioseparation, and Cell Technology, Wiley, New York, USA (2010)
|
51 |
https://shop.pall.com/us/en/biotech/filtration, February 25 (2020).
|
52 |
A. DiLeo, A. Allegrezza, and S. Builder, "High resolution removal of virus from protein solutions using a membrane of unique structure", Nat. Biotechnol., 10, 182 (1992).
DOI
|
53 |
A. J. DiLeo, D. A. Vacante, E, and F. Deane, "Size exclusion removal of model mammalian viruses using a unique membrane system, Part I: Membrane qualification", Biologicals, 21, 275 (1993).
DOI
|
54 |
A. J. DiLeo, D. A. Vacante, E, and F. Deane, "Size exclusion removal of model mammalian viruses using a unique membrane system, Part II: Model qualification and process simulation", Biologicals, 21, 287 (1993).
DOI
|
55 |
B. Hughes, A. Bradburne, A. Sheppard, and D. Young, "Evaluation of anti-viral filters", Dev. Biol. Stand., 88, 91 (1996).
|
56 |
J. Parkkinen, A. Rahola, L. von Bonsdorff, H. Tolo, and E. Torma, "A modified caprylic acid method for manufacturing immunoglobulin G from human plasma with high yield and efficient virus clearance", Vox Sang., 90, 97 (2006).
DOI
|
57 |
I. S. Kim, Y. W. Choi, Y. Kang, H. M. Sung, K. W. Sohn, and Y. S. Kim, "Improvement of virus safety of an antihemophilc factor IX by virus filtration process", J. Microbiol. Biotechnol., 18, 1317 (2008).
|
58 |
J. X. Zhou, F. Solamo, T. Hong, M. Shearer, and T. Tressel, "Viral clearance using disposable systems in monoclonal antibody commercial downstream processing", Biotechnol. Bioeng., 100, 488 (2008).
DOI
|