On the origin of serum: Controlling FBS supply, a riposte from the ESPA

Do not confuse the methods and purposes for controlling the serum supply chain by misleading end-users into believing that some origins of serum are better and safer than others, says the European Serum Products Association (ESPA).

Last month, Bioprocess Insider published an article entitled: ‘Quality FBS, or just BS? Industry turning to supply chain certification’. The article detailed a presentation from the International Serum Industry Association (ISIA) at BPI Europe in Vienna, Austria and highlighted the application of independent audits, geographic testing and age testing in determining the quality of Fetal Bovine Serum (FBS) and detecting fraudulent labeling of the raw material.

However, the methods used to detect misrepresented origins or contents are no justification for promoting some geographic origins – specifically Australia, New Zealand and the US – as better quality and safer than other origins, Marc Wintgens from the European Serum Products Association (ESPA) and Percy Hawkes, an international agriculture and animal health consultant, argue in the following riposte:

No one continent or country which produces FBS seems to have a real advantage over the others, the ESPA claims. Image: iStock/locknloadlabrador

Serum from Australia, New Zealand and USA are still promoted to have the lowest risk of viral contamination and BSE

This myth has been disproved in a 2015 publication entitled ‘Fetal bovine serum: geographic origin and regulatory relevance of viral contamination’ by Hawkes[1]. The article compares the disease status of cattle populations from 30 countries, including Oceania, the Americas, and Europe, based on disease reports from each country to the World Organization for Animal Health (OIE).

Bovine serum from all countries, including Australia, New Zealand, and the USA must be tested and/or treated for the same adventitious bovine viruses[2] that are found in all cattle populations throughout the world (BVD, PI3, Reo3, BAV, BPV, BRSV, and IBR)[3]. It should also be noted that bovine serum from Australia must be tested or treated for Simbu sero-group viruses (Akabane and Aino), as well as Bovine Ephemeral Fever virus, which do not exist in any of the other major serum exporting countries[4].

The Hawkes (2015) article concludes that:

“Regardless of geographical location, FBS from all 30 countries needs to be tested and treated for the presence of multiple viruses. No one continent or country which produces FBS seems to have a real advantage over the others, since all countries have viruses of regulatory concern needing to be tested for and eliminated in FBS.

“Just because the prices of FBS from certain origins might be higher, does not mean that those origins are ‘safer,’ in terms of the number of viruses needing to be tested for and eliminated.

“Once having passed importation requirements, safety testing and sterilization treatment, FBS is considered to be free of all viruses of importation concern, and comparable to FBS from any other approved origin.”

In relation to the use of bovine serum in processes where viral safety is important, ESPA recommends the use of > 25 kGy gamma irradiation as the solution of choice. Such treatment has absolute preference over geographical origin as a viral safety parameter. ESPA refers to the article on Gamma Irradiation of Animal Serum, by Plavsic M, et.al. 2016[5].  ESPA believes that such treatment enhances the viral safety equivalency of bovine serum regardless of its origin.

Besides viral safety, the same article by Hawkes handles the irrelevance of BSE in the context of blood products:

“However, as knowledge of BSE advanced, scientists and government regulators from the World Organization for Animal Health (OIE), the European Union (EU) and the United States Department of Agriculture (USDA) determined that BSE is not transmitted in bovine blood or blood products, when appropriate slaughter practices are adhered to.”

Truthfulness in labeling is the purpose of traceability audits, geographic and age testing

The ISIA traceability audit certification program started by the International Serum Industry Association was created in order to promote transparency and honesty in the processing and labeling of animal serum, with the purpose of bringing into compliance, companies who did not control their supply chain.

At the same time, it must be underlined that traceability is not aimed at identifying a higher or lower quality product based on its geographical origin. Rather, high-quality serum can originate in any country, as long as it is collected, imported, and processed following all the applicable regulatory and industry requirements.

Let’s not confuse the methods and purposes for controlling the serum supply chain, by misleading end-users into believing that some origins of serum are better and safer than others. In terms of viral safety >25 kGy irradiation adds a lot more value than geographical origin.

Marc Wintgens heads regulatory affairs at the European Serum Products Association (ESPA) and is director of European serum supply company Biosera. Percy Hawkes is a consultant for international agriculture and animal health at Hawkes Consulting.

[1] Hawkes, PW. Fetal bovine serum: geographic origin and regulatory relevance of viral contamination, Bioresources and Bioprocessing 2015 2:34. https://doi.org/10.1186/s40643-015-0063-7

[2] USDA 9 CFR 113.46-53; and EMEA-CPMP-BWP-1793-02

[3] Bovine Viral Diarrhea, ParaInfluenza 3, Reovirus 3, Bovine Adenovirus, Bovine Parvovirus, Bovine Respiratory Syncytial Virus, and Infectious Bovine Rhinotracheitis.

[4] Veterinary Services Notice (1992) Ruminant serum (RS) import requirements. USDA-APHIS, October 29, 1992, and
Veterinary Services Notice 98-05 (1998) Ruminant serum import requirements, USDA-APHIS, March 19, 1998

[5] Plavsic M, Nims R, Wintgens M, Versteegen R. Gamma irradiation of animal serum: validation of efficacy for pathogen reduction and assessment of impacts on serum performance. BioProcess J, 2016; 15(2): 12–21. http://dx.doi.org/10.12665/J152.Plavsic.