Qualification of a novel inline spiking method for virus filter validation

Biotechnology Progress

Volumn 27, Issue 1, 2011, Pages 121-128

  Lutz, Herbert ^a   Chang, Wayne ^b   Blandl, Tamas ^b   Ramsey, Gisela ^c   Parella, Joe ^c   Fisher, John ^d   Gefroh, Eva ^d  

^a Millipore Corporation   (United States)

^b AMGEN INC   (United States)

^c EMD Millipore   (United States)

^d AMGEN INC   (United States)

Author keywords

Inline spiking; virus filter validation; Virus filtration; Virus safety; Virus spiking studies

Indexed keywords

BIOPROCESSING; DIRECT MEASUREMENT; IN-LINE; INJECTION RATES; MANUFACTURING PROCESS; PREFILTERS; PROTEIN SOLUTION; SCALE DOWN; SPIKING STUDY; TRACE CONTAMINANTS; VIRUS REMOVAL;

MAMMALS; PROTEINS; THROUGHPUT;

VIRUSES;

ADSORPTION; ARTICLE; FILTRATION; INSTRUMENTATION; ISOLATION AND PURIFICATION; STANDARD; VALIDATION STUDY; VIRUS;

ADSORPTION; FILTRATION; VIRUSES;

MAMMALIA; MINUTE VIRUS OF MICE; PARVOVIRUS;

EID: 79851480229     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.500     Document Type: Article

References (18)

1. Q5A(R1), Quality of biotechnological products, "Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin." International Conference on Harmonization, c/o IFPMA, Geneva, SW, September 25, 1999. Available at.
2. EMEA/CHMP/BWP/398498/2005 "Guideline on virus safety evaluation of biotechnological investigational products", London, ENG, July 2008. Available at.
3. EMEA/CPMP/BWP/268/95 "Note for guidance on virus validation studies: the design, contribution, and interpretation of studies validating the inactivation and removal of viruses", London, UK, February 1996. Available at.
4. Siwak M, Hong A, Cormier JR, Kinzlmaier D. U.S. Pat. 7, 465, 397, 2008.
5. Siwak M, Hong A, Cormier JR, Kinzlmaier D. U.S. Pat. 7, 118, 675, 2006.
6. Brough H, Antoniou C, Carter J, Jakubik J, Xu Y, Lutz H. Performance of a novel viresolve NFR virus filter. Biotechnol Prog. 2002; 18: 782-795.
7. Romanowski P, Schleh M, Rajurs V, Chinniah S, Dehghani H. Variables affecting titer and long-term stability of virus stocks. BioProcess Int. 2008; 2: 44-52.
8. Spearman C. The method of "right and wrong cases" (constant stimuli) with Gauss' formula. Br J Psychol. 1908; 2: 227-242.
9. Karber G. 50% end-point calculation. Arch Exp Pathol Pharmak. 1931; 162: 480-483.
10. Millipore Corporation, Viresolve® NFP Filter Data Sheet, Lit No. DS2174EN00 Rev. D 4/07.
11. Millipore Corporation, Viresolve® Pro Filter Data Sheet, Lit No. DS0006EN00 Rev. C 6/09.
12. Bolton G, Spector S, Lacasse D. Increasing the capacity of parvovirus-retentive membranes: performance of the Viresolve® prefilter. Biotechnol Appl Biochem. 2006; 43: 55-63.
13. Madrid L, Ireland T, McNerney T. Viresolve® NFP filtration development for a 150kD Protein: characterization of the fouling species and use of a novel virus prefilter. Poster at Recovery of Biological Products Conference RXII. Phoenix, AZ; 2006.
14. Lutz H, Siwak M, Bolton G, Ireland Y. Viral Filtration of Plasma-Derived Human IgG, Downstream, PPB '03. Amersham Biosciences, Uppsala, Sweden, 2004: 21.
15. Ireland, T, Lutz, H, Siwak, M, Bolton, G. Viral filtration of plasma-derived human IgG: a case study using viresolve NFP. Biopharm Int. 2004; 17: 38-44.
16. Wickramasinghe SR, Kalbfus B, Zimmerman A, Thom V, Reichl U. Tangential flow microfiltration and ultrafiltration for human influenza A virus concentration and purification. Biotechnol Bioeng. 2005; 92: 199-208.
17. Truskey GA, Gabler R, DiLeo A, Manter T. The effect of membrane filtration upon protein conformation. J Parenter Sci Technol. 1987; 41: 180-193.
18. PDA, Preparation of virus spikes used for virus clearance studies, Technical Report No. 47, ISBN: 978-0-939459-27-8, PDA, Bethesda, MD, 2010.