Effects of varying virus-spiking conditions on a virus-removal filter Planova™ 20N in a virus validation study of antibody solutions

Biotechnology Progress

Volumn 27, Issue 1, 2011, Pages 162-169

  Hongo Hirasaki, Tomoko ^a   Yamaguchi, Kazuhito ^b   Yanagida, Kouichirou ^a   Hayashida, Hirohisa ^a   Ide, Shoichi ^a  

^a Asahi Kasei Medical Co   (Japan)

^b YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

Filter performance; Parvovirus; Virus preparation method; Virus removal filter; Virus spike

Indexed keywords

FILTER PERFORMANCE; FILTRATION VOLUME; LOAD CONDITION; LOG REDUCTION VALUES; NORMAL LOADS; PARVOVIRUS; TRANSMISSION ELECTRON MICROPHOTOGRAPHY; VALIDATION STUDY; VIRUS REMOVAL; VIRUS REMOVAL FILTER;

BODY FLUIDS; PHOTOGRAPHY;

VIRUSES;

VIRUS ANTIBODY;

ARTICLE; CULTURE MEDIUM; FILTRATION; IMMUNOLOGY; INSTRUMENTATION; ISOLATION AND PURIFICATION; PORCINE PARVOVIRUS; TRANSMISSION ELECTRON MICROSCOPY; ULTRASTRUCTURE; VALIDATION STUDY;

ANTIBODIES, VIRAL; CULTURE MEDIA, SERUM-FREE; FILTRATION; MICROSCOPY, ELECTRON, TRANSMISSION; PARVOVIRUS, PORCINE;

PARVOVIRUS; PORCINE PARVOVIRUS;

EID: 79851500294     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.533     Document Type: Article

References (22)

1. EMEA. Note for Guidance on Plasma-Derived Medicinal Products, CPMP/BWP/269/95 rev. 3. London: EMEA; 2001.
2. Kim ID, Choi YW, Lee SR, Sung HM. Cold ethanol fractionation and heat inactivation of hepatitis A virus during manufacture of albumin from human plasma. Biotechnol Bioprocess Eng. 2004; 9: 65-68.
3. Brorson K, Krejci S, Lee K, Hamilton E, Stein K, Xu Y. Brackted generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins. Biotechnol Bioeng. 2003; 82: 321-329.
4. Horowitz B, Lazo A, Grossberg H, Page G, Lippin A, Swan G. Virus inactivation by solvent/detergent treatment and the manufacture of SD-Plasma. Vox Sang. 1998; 74 (Suppl. 1): 203-206.
5. Hongo-Hirasaki T, Yamaguchi K, Yanagida K, Okuyama K. Removal of small viruses (parvovirus) from IgG solution by virus removal filter Planova 20N. J Membr Sci. 2006; 278: 3-9.
6. Santagostino E, Mannucci PM, Gringeri A, Azzi A, Morfini M, Musso R, Santoro R, Schiavoni M. Transmission of parvovirus B19 by coagulation factor concentrates exposed to 100 degrees C heat after lyophilization. Transfusion. 1997; 37: 517-522.
7. Blumel J, Schmidt I, Effenberger W, Seitz H, Willkommen H, Brackmann HH, Lower J, Eis-Hubinger AM. Parvovirus B19 transmission by heat-treated clotting factor concentrates. Transfusion. 2002; 42: 1473-1481.
8. Wu CG, Mason B, Jong J, Erdman D, McKernan L, Oakley M, Souice M, Evatt B, Yu MY. Parvovirus B19 transmission by a high-purity factor concentrate. Transfusion. 2005; 45: 1003-1010.
9. EMEA. CPMP/ICH/295/95, ICH Q5A: Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. London: EMEA; 1997.
10. Marques BF, Roush DJ, Göklen KE. Virus filtration of high-concentration monoclonal antibody solutions. Biotechnol Prog. 2009; 25: 483-491.
11. Cabatingan M. Impact of virus stock quality on virus filter validation, a case study. BioProcess Int. 2005; 3 (Suppl.): 39-43.
12. Bolton G, Cabatingan M, Rubino M, Lute S, Broroson K, Bailey M. Normal-flow virus filtration; detection and assessment of the endpoint in bioprocessing. Biotechnol Appl Biochem. 2005; 42: 133-142.
13. Genest P, Campbell J, Crump S, Cabatingan M, Miao F. An improved method for virus filter qualification and implementation, using flow decay to determine processing endpoint. BioProcess Int. 2006; 4: 44-47.
14. Tarrach K, Meyer A, Dathe JE, Sun H. The effect of flux decay on a 20-nm nanofilter for virus retention. BioPharm Int. 2007; 20: 58-64.
15. Lute S, Bailey M, Combs J, Sulumar M, Broroson K. Phage passage after extended processing in small-virus-retentive filters. Biotechnol Appl Biochem. 2007; 47: 141-151.
16. Ide S, Noda T. Filter membrane for physiologically active substances. US Pat. 6, 797, 169, 2004.
17. Bradford M. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem. 1976; 72: 248-254.
18. Morimoto T, Fujisaki Y, Ito Y, Tanaka Y. Biological and physicochemical properties of porcine parvovirus recovered from stillborn piglets. Natl Inst Anim Health Q. 1972; 12: 133-144.
19. Reed LJ, Muench H. A simple method of estimating fifty per cent endpoints. Am J Hyg. 1938; 27: 493-497.
20. Yamaguchi K, Miyagawa E, Takahashi H, Miyazaki T, Ikeda H. Electron microscopic estimation of removal of parvovirus B19 (HPVB19) by nanofiltration with novel filter membrane. J Membr Sci. 2007; 298: 99-109.
21. Tsurumi T, Sato T, Osawa N, Hitaka H, Hirasaki T, Yamaguchi K, Hamamoto Y, Manabe S, Yamashiki T, Yamamoto N. Structure and filtration performances of improved cuprammonium regenerated cellulose hollow fiber (improved BMM hollow fiber) for virus removal. Polym J. 1990; 22: 1085-1100.
22. Hongo-Hirasaki T, Komuro M, Ide S. Effect of antibody solution conditions on filter performance for virus removal filter Planova™ 20N. Biotechnol Prog. 2010; 26: 1080-1087.