FBS presents a significant risk to the manufacture of medicines, as it contains varying amounts of endotoxins, haemoglobin and other unwanted or harmful substances. Endotoxins may not only affect cell growth, they may also transmit disease, if serum is used in the production of vaccines, such as those against measles, mumps and polio, or in the production of medicines to treat cancer and multiple sclerosis. These are among the reasons why many health authorities in Denmark and other countries advise against use of foetal calf serum. It is particularly feared that cattle with mad cow disease (BSE: bovine spongiform encephalopathy) might be used for serum production.
“The use of serum or other poorly defined reagents is not recommended in the production of new biologicals from cell culture, and wherever possible chemically defined alternatives should be sought.”
-WHO, Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks, 2010
