Counterfeit serum threatens pharma, vaccine safety

Sales of counterfeit foetal bovine serum (FBS) - a reagent used in the production of biologic drugs and vaccines - are on the rise, according to report in Nature.

FBS may contain infectious agents such as bovine spongiform encephalopathy (BSE), so material from low-risk countries such as Australia, New Zealand and the US carries premium pricing, and creates an incentive for fraudsters to mislabel the country of origin for FBS from higher-risk countries. Authentic bottles are sometimes refilled with bogus material, according to the report.

The problem is so acute that FBS supplier GE Healthcare and traceability specialist Oritain have launched a screening test designed to identify the country of origin of the material by examining trace elements in FBS, which change in accordance with the diet of source cows.

GE is already traceability-certified by the International Serum Industry Association (ISIA), but will now put its sera products through the new testing process, which it says "goes beyond industry-standard traceability practices."

FBS is a cell growth supplement used in the manufacturing of biopharmaceuticals and vaccines for human health and veterinary purposes, as well as in basic research and drug discovery. Serum plays an important role in the cell-based production of high-quality vaccines and therapeutics for people and animals around the world, says GE.

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