The use of animal serum as a vital component in biotechnology manufacturing processes has raised questions regarding the reliability of geographic origin and possible adulteration. The International Serum Industry Association (ISIA) has implemented a traceability certification program designed to demonstrate traceability from slaughterhouse to the end user. Certification is based on an audit performed by an approved independent third-party auditor according to an established audit plan, using a comprehensive checklist. Recent advances have led to the development of a complementary testing program to determine the material’s geographic origin. The methodology described in this paper differentiates fetal bovine serum (FBS) from newborn calf serum based on biochemical composition.
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