Code No.	Description	Origin	Link
	FBS-001	Fetal Bovine Serum	EU-approved
	FBS-002	Fetal Bovine Serum	EU-approved with COS
	FBS-003	Fetal Bovine Serum	USA
	FBS-004	Fetal Bovine Serum	Australia

Tested for:

• Endotoxin
• Mycoplasma
• Bacterial  L-forms
• Viral contamination
• Viral antibodies against BVD-MD, BHV-1, PI-3

Fetal Bovine Serum (FBS; also named as 'FCS')

is still widely used in animal cell culture as an essential supplement. Bioprocessing on the industrial scale, is using FBS in substantial quantities because of increased protein-based drug production. Recently some concern was raised with the use of animal derived products in manufacturing processes of therapeutic proteins and vaccines. It has long been evaluated to cultivate cells in a serum free condition; however, after 20 years of bioprocessing technology, serum and protein free media have only been established for selected protocols. Being a by-product of the beef-packing industry, FBS can only be obtained where sufficient numbers of fetuses become available during the slaughtering process. The FBS is supplied either from South America, the US, and Australia.

Risk assessment and import restrictions

Derived from fetal blood, FBS may bear 4 possible risks:Presence of adventitious bovine viruses in the sterile end-product. At least 17 different types of viruses are able to penetrate the bovine placenta, and can thus be found in the fetal blood. The most common are Food-and-Mouth-Disease, Bovine Rhinotracheitis (IBR), Bovine Parainfluenza (PI3), and Bovine Diarrhoe virus (BVD). With respective geographical origins, contamination with Blue-Tongue-Virus (BTV) is also an issue. Infections of the dams by Bovine Spongiform Encephalopathy (BSE) have recently been linked with the long-known Creutzfeld-Jakob disease in humans. Consequently, all countries have to certify the absence of BSE prior to export their bovine serum products. Even a single case like with Canada, or more recently the US, may lead to a strict import ban as currently implemented by most Asian countries. During harvesting, and centrifugation of fetal blood, serum may become contaminated by bacteria and mycoplasma. Sterile filtration and strict sterile control of the end-product is therefore one of the key responsibilities of serum suppliers. Cell wall residues of gram negative bacteria, commonly named 'endotoxins', are another thread in the serum manufacturing process. Sloppy collecting and processing methods of the raw serum, may result in a higher endotoxin burden of the respective serum lot. Endotoxins are very hard to remove from the serum, and are even capable to pass the different filtration steps. Endotoxins can influence cell growth, but may also be passed to the end-product, intended for human therapy.

While global demand for FBS has steadily increased over the past years, import of FBS into the US and the EU are strictly controlled. Whereas the EU allows South American serum for the academic research market, the USDA keeps the border closed for South American serum. FBS used in bioprocessing to manufacture therapeutic proteins for a global market has to be either Australian/New Zealand or US sourced material. Most protocols for FBS in bioprocessing require the exposion to gamma irradiation at a minimum dose of 30 kGray (EMEA guideline).