Detection of Cache Valley Virus in Biologics Manufactured in CHO Cells - Avoid manufacturing failures by effective viral inactivation. - BioPharm International

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Detection of Cache Valley Virus in Biologics Manufactured in CHO Cells
Avoid manufacturing failures by effective viral inactivation.


BioPharm International
Volume 21, Issue 10

REFERENCES

1. Hojman F, et al. Biological and molecular characterization of an endogenous retrovirus present in CHO/HBs—A Chinese hamster cell line. Dev Biol Stand. 1989;70:195–202.

2. Dinowitz M, et al. Recent studies on retrovirus-like particles in Chinese hamster ovary cells. Dev Biol Stand. 1992;76:210–207.

3. Garnick RL. Experience with viral contamination in cell culture. Dev Biol Stand. 1996;88:49–6.

4. Nims RW. Detection of adventitious viruses in biologicals—A rare occurrence. Dev Biol. 2006;123:153–164.

5. US FDA. Points to consider in the characterization of cell lines used to produce biologicals. FDA/CBER, 1993.

6. US FDA. Points to consider in the manufacture and testing of monoclonal antibody products for human use. FDA/CBER, 1997.

7. Gonzalez-Scarano F, Nathanson N. Bunyaviridae. In: Fields BN, Knipe DM, Howley PM, editors. Fields Virology, 3rd edition, Philadelphia, PA: Lippincott-Raven; 1996. p.1473–1504.

8. Blackmore CG, Grimstad PR. Cache Valley and Potosi viruses (Bunyaviridae) in white-tailed deer (Odocoileus virginianus): experimental infections and antibody prevalence in natural populations. Am J Trop Med Hyg. 1998;59:704–709.

9. Sahu SP, et al. Serologic survey of cattle in the northeastern and north central United States, Virginia, Alaska, and Hawaii for antibodies to Cache Valley and antigenically related viruses. Am J Trop Med Hyg. 2002;67:119–122.

10. McLean RG, Calisher CH, Parham GL. Isolation of Cache Valley virus and detection of antibody for selected arboviruses in Michigan horses in 1980. Am J Vet Res 1987;48:1039–1041.

11. Buescher EL, et al. Cache Valley virus in the Del Mar Va Peninsula. I. Virologic and serologic evidence of infection. Am J Trop Med Hyg. 1970;19:493–502.

12. Sexton DJ, et al. Life-threatening Cache Valley virus infection. N Engl J Med. 1997;336:547–550.

13. Campbell GL, et al. Second human case of Cache Valley virus disease. Emerg Infect Dis. 2006;12:854–856.

14. Nims R, et al. Adventitious agents: Concerns and testing for biopharmaceuticals. In: Rathore AS, Sofer G, editors. Process validation in manufacturing of biopharmaceuticals: guidelines, current practices, and industrial case studies. Boca Raton, FL: CRC Press/Francis Informa; 2005. p. 143–67.

15. Powell JW. Personal communication.

16. Onions D, unpublished data.


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