Limits in virus filtration capability? Impact of virus quality and spike level on virus removal with xenotropic murine leukemia virus

Biotechnology Progress

Volumn 31, Issue 1, 2015, Pages 135-144

  Roush, David J ^a   Myrold, Adam ^a   Burnham, Michael S ^b   Hughes, Joseph V ^b  

^a Biologics Process Development Process Development and Engineering   (United States)

^b WUXI APPTEC   (China)

Author keywords

Dynamic light scattering; Filtration model; V75; Viral filtration; XMuLV

Indexed keywords

ANTIBODIES; CHROMATOGRAPHY; DISEASES; DYNAMIC LIGHT SCATTERING; IMPURITIES; LIGHT SCATTERING; MAMMALS; MONOCLONAL ANTIBODIES; ONCOGENIC VIRUSES; PROTEINS; PURIFICATION; QUALITY CONTROL;

CHROMATOGRAPHIC PROCESS; FILTRATION CHARACTERISTICS; FILTRATION MODEL; LIMITS OF QUANTITATIONS; MONOCLONAL ANTIBODIES (MABS); MURINE LEUKEMIA VIRUS; TECHNICAL REQUIREMENT; XMULV;

VIRUSES;

MAMMALIA; XENOTROPIC MURINE LEUKEMIA VIRUS;

MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

BIOLOGICAL MODEL; BIOTECHNOLOGY; CHEMISTRY; FILTRATION; ISOLATION AND PURIFICATION; MURINE LEUKEMIA VIRUS; PHOTON CORRELATION SPECTROSCOPY; PROCEDURES; SAFETY; STANDARDS; VIRAL PLAQUE ASSAY;

ANTIBODIES, MONOCLONAL; BIOTECHNOLOGY; DYNAMIC LIGHT SCATTERING; FILTRATION; LEUKEMIA VIRUS, MURINE; MODELS, BIOLOGICAL; RECOMBINANT PROTEINS; SAFETY; VIRAL PLAQUE ASSAY;

EID: 84923272010     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.2020     Document Type: Article

References (20)

1. Miesegaes G, Bailey M, Willkommen H, Chen Q, Roush D, Blümel J, Brorson K. Proceedings of the 2009 Viral Clearance Symposium. Dev Biol (Basel). 2010;133:3-101.
2. Roberts PL. Virus elimination during the purification of monoclonal antibodies by column chromatography and additional steps. Biotech Prog. 2014. DOI 10.1002/btpr.1984.
3. Food and Drug Administration. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, issued by FDA CBER (Center for Biologics Evaluation and Research), 27 February 1997.
4. International Conference on Harmonisation (ICH) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Q5A. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland; 1999.
5. Gefroh E, Dehghani H, Mcclure M, Connell-Crowley L, Vedantham G. Use of MMV as a single worst-case model virus in viral filter validation studies. PDA J Pharm Sci Tech. 2014;68:297-311.
6. PDA Technical Report 47. Preparation of Virus Spikes Used for Virus Clearance Studies. Bethesda, MD: Parenteral Drug Association; 2010.
7. Miesegaes G, Lute S, Dement-Brown J, Kaushal S, Strauss D, Chen D, Brorson K. A survey of quality attributes of virus spike preparations used in clearance studies. PDA J Pharm Sci Tech. 2012;68:420-433.
8. Slocum A, Burnham M, Genest P, Venkiteshwaran A, Chen D, Hughes J. Impact of virus preparation quality on parvovirus filter performance. Biotechnol Bioeng. 2013;110:229-239.
9. Marques BM, Roush DJ, Goklen KE. Virus filtration of high-concentration monoclonal antibody solutions. Biotech Progr. 2009;25:483-449.
10. TM 20N in a virus validation study of antibody solutions. Biotech Progr. 2011;27:162-169.
11. Lute S, Bailey M, Combs J, Sukumar M, Brorson K. Phage passage after extended processing in small-virus-retentive filters. Biotechnol Appl Biochem. 2007;47:141-151.
12. Follman D, Fahrner RL. Factorial screening of antibody purification processes using three chromatography steps without Protein A. J Chromatogr A. 2004;1024:79-85.
13. Ireland T, Bolton G, Noguchi M. Optimizing virus filter performance with prefiltration. BioProcess Int. 2005;9:44-47.
14. Khan NZ, Parrella JJ, Genest PW, Colman MS. Filter preconditioning enable representative scaled-down modelling of filter capacity and viral clearance by mitigating the impact of virus spike impurities. Biotechnol Appl Biochem. 2009;52:293-301.
15. max testing for practical microfiltration train scale-up in biopharmaceutical processing. Pharm Tech 2005;19:64-76.
16. Laska M, Brooks R, Gayton M, Pujar N. Robust scale-up of dead end filtration: impact of filter fouling mechanisms and flow distribution. Biotech Bioeng. 2005;92:308-320.
17. Ho C-C, Zydney AL. Effect of membrane morphology on the initial rate of protein fouling during microfiltration. J Membr Sci. 1999;155:261-275.
18. max analysis. Desalination 2002;146:75-81.
19. Miesegaes G, Lute S, Brorson K. Analysis of viral clearance unit operations for monoclonal antibodies. Biotechnol Bioeng. 2010;106:238-246.
20. Stuckey J, Strauss D, Venkiteshwaran A, Gao J, Luo W, Quertinmount M, O'Donnell S, Chen D. A novel approach to achieving modular retrovirus clearance for a parvovirus filter. Biotech Progr. 2014;30:79-85.