We believe in transparency. Any reputable serum supplier should be willing to cooperate and share certificate of suitability, certificate of origin, and/or a certificate of analysis. On –site facility inspection should be welcomed and encouraged. Credibility can be demonstrated by suppliers being registered or inspected through internationally recognized bodies such as FDA, ISO, USDA, TRACES, or industry associations. As Davis and Hirschi concluded in the BioProcessing Journal article Fetal Bovine Serum: Risk Management, “Any hesitation in this regard on the part of a supplier is a serious cause for concern.”[1]
Once you receive the COA from your supplier compare it to other industry COAs, if it doesn’t match up (testing specs, results, etc.) ask why.
Be very cautious when a company is offering FBS at a price that seems “too good to be true” or much lower than quotations from others. There is probably a valid reason to question the composition or sourcing of the cheaper product.
The most common form of misrepresentation is declared origin. This happens when FBS from a less expensive origin such as Mexico or South America, is sold as the more expensive US or Australian origin. Misrepresentation can also happen by mixing the origins and only declaring the more expensive origin. It causes violations of import regulations, declaration of material for clinical trials, and experiments published in journals. Falsified origins violate government, industry and consumer standards of honesty and traceability while generating a greater profit for the seller at the expense of the end user.
In today’s all-time high FBS market where the demand is exceeding the supply, FBS can be misrepresented by mixing it with serum from non-fetal animals such as newborn and labeling the finished product as Fetal Bovine Serum. This again generates large profits at the expense of the end user and will cause serious regulatory problems for companies that are manufacturing products for commercial use or for published journal articles referencing FBS.
Atlas Biologicals produces several blended products (FBS Products and FBS alternatives) and the prices are reflective. Our FBS alternatives are not labeled “Fetal Bovine Serum”. We have been in the business of developing FBS suitable alternatives for many years with the intention of providing high quality serum products to the end user at substantial savings.
Download article about fraudulent serum blending for more information
Article Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=117863
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http://www.serumindustry.org/documents/Davis_Hirschi_article.pdf
