Biowest informs FBS sourcing concerns are ‘ill-founded’

Nuaille, France: – Biowest SAS, the world-respected supplier of animal sera and cell culture media, informs that recent concerns about sourcing high quality Fetal Bovine Serum (FBS) are ill-founded.

Biowest confirms that FBS can safely be sourced from any country provided normal industry standards and regulatory guidelines are met.

It spoke out following an article entitled Shifting Qualities of FBS May Impact Your Experiments by Dr. Alyssa Master, in Genetic and Biotechnology News (GEN), which provided inaccurate information on sourcing high quality FBS.

These claims have been refuted by Biowest Regulatory Affairs Consultant and Veterinarian, Dr. Percy W. Hawkes in a subsequent GEN article: High-Quality FBS May Come from any Authorized Country of Origin, which appeared in the April issue.

Inaccurate conclusions

“Some information presented in the (Master) article is not based on the most recent scientific and regulatory information available, and can lead to inaccurate conclusions,” Dr. Hawkes writes.

He says Dr. Master is correct in describing the importance of FBS in cell culture and stating that the International Serum Industry Association (ISIA), of which Biowest is a founding member, has started a traceability program in order to promote transparency and honesty in the processing and labeling of animal serum.

“But traceability is not aimed at identifying a higher or lower quality product based on its geographical origin. Rather, high-quality serum needed for the reproducibility of scientific research, can originate from any country, as long as it is collected, imported, and processed following all the applicable regulatory and industry requirements,” Dr. Hawkes declares.

BSE ‘not a concern’ for FBS

Dr. Hawkes also takes issue with the claim that bovine spongiform encephalopathy (BSE) is one of the diseases of concern when selecting a country of origin for FBS, noting that “some FBS companies continue to promote certain countries of origin of FBS based on the obsolete Geographical BSE Risk Assessment (GBR) classification.”

In 2011 the World Organization for Animal Health (OIE), created a new BSE risk classification for countries and products, in an effort to put an end to misinformation about the trade risks associated with BSE, clarifying that blood and blood products do not play a role in the transmission of BSE.

“The OIE also emphasized that regardless of the BSE status of the exporting country, blood and blood products should not be subject to any import restrictions relating to BSE,” says Dr. Hawkes, noting that the US Food & Drug Administration (FDA) and US Department of Agriculture (USDA) have also both recently determined that BSE is not transmitted by FBS.

Australian ‘zero risk’ misconception

Dr. Hawkes also takes issue with the implication in the earlier GEN article that Australian products have the lowest viral risks.

“Being an island and having strict importation regulations, does not mean that Australia enjoys the same fortunate animal health status as New Zealand. Some serum companies have erroneously put Australia in the same low viral risk status as New Zealand,” says Dr. Hawkes.

He notes that while New Zealand is indeed free of several cattle viruses, including Bluetongue, the Simbu serogroup viruses (Akabane and Aino), and Bovine Ephemeral Fever, all of these viruses are present in Australia.

“It should be noted that FBS from all countries, including New Zealand and Australian FBS must be tested and/or treated for the same adventitious bovine viruses (BVD, PI3, Reo3, BAV, BPV, BRSV, and IBR) that are found in all regions of the world. Neither New Zealand nor Australia are free from these adventitious bovine virus diseases,” writes Dr. Hawkes.

FMD distinction ‘pointless’

Finally, Dr. Hawkes states that the assertion that Australia and New Zealand are free of foot and mouth disease (FMD) is ‘pointless’, because all major serum-producing countries are officially recognized by the OIE as being free of FMD.

A 2015 article by Hawkes, entitled Fetal Bovine Serum- Geographical Origin and Regulatory Relevance of Viral Contamination, gives further detailed information regarding of the presence of bovine viruses of regulatory concern, present in the major FBS producing regions of the world.

Dr. Hawkes concludes:
“High-quality FBS needed for the reproducibility of scientific research can come from any country of origin, as long as regulatory and industry standards are adhered to.”

About Biowest

Biowest SAS (Biowest) is the European leader in the collection and processing of animal sera and cell culture media, offering the widest range of sera and media available on the market. Biowest controls the production of the sera throughout the entire process, from collections around the world to final shipment of bottled serum from its warehouse.

Biowest offers standard cell culture media as well as custom-made formulations for specific applications, using its outstanding knowledge of cell culture products.

Biowest can also offer highest quality and premium service, ability to address special requirements and full traceability and security guaranteed by vertical integration.

Founded in 1987, Biowest has since 2004 been a member of the Viking/Serascandia group, collectors of animal by-products in Latin America; thus becoming the first serum company vertically integrated from raw material to finished product.

Biowest is also a founding member of ISIA: the International Serum Industry Association that establishes, promotes and assures conformity with uncompromised standards of excellence and ethics for the animal serum supply industry worldwide.