Fetal bovine serum: geographic origin and regulatory relevance of viral contamination

Abstract

The article aims to clarify an existing misunderstanding by the users of fetal bovine serum (FBS), who assume that certain countries, like Australia and New Zealand, have fewer cattle disease viruses and pose less risk for the presence of viruses, than do the other FBS producing countries. The article reviews the 2013 information from the World Organization for Animal Health (OIE), regarding the presence and absence of the 14 viruses of concern for FBS in the cattle populations of the 30 major FBS producing countries of the world. United States Department of Agriculture (USDA) and European Union (EU) regulations have identified 8 adventitious viruses and 6 additional viruses of importation concern that need to be tested for or eliminated in FBS, viruses that can cross the placental barrier from the donor cow to the fetus. A comparison is made regarding the number of viruses of concern reported presently in each of the FBS producing countries. The results of the comparison reveal that four Scandinavian countries report the fewest number of viruses of concern for FBS (six in total), while Australia and the USA are among the countries reporting the highest numbers of viruses of concern for FBS (ten in total). FBS from Australia and the USA has thus no advantage over the other FBS producing countries, regarding the number of viruses needed to be tested for and eliminated.

Keywords

Adventitious viruses / Animal health status / European Medical Agency (EMEA) / Fetal bovine serum (FBS) / United States Department of Agriculture (USDA) / Viruses of importation concern / World Organization for Animal Health (OIE)

References

Cruz H, Moreira J, Stacey G, Dias E, Hayes K, Looby D, . Adaptation of BHK cells producing a recombinant protein to serum-free media and protein-free medium. Cytotechnology, 1998

Davis D, Drake Hirschi S (2014) Fetal bovine serum: what you should ask your supplier and why. BioProcess J 13(1):19–21. http://dx.doi.org/10.12665/J131.DavisHirschi

Siegel W, Foster L (2013) Fetal bovine serum: the impact of geography. BioProcess J 12(3):28–30. http://dx.doi.org/10.12665/J123.Siegel

Veterinary Services Notice (1992) Ruminant serum (RS) import requirements, USDA-APHIS, October 29, 1992

Veterinary Services Notice 98-05 (1998) Ruminant serum import requirements, USDA-APHIS, March 19, 1998