GE announced its partnership with testing services firm Oritain this week, explaining the idea is to help drug firms verify the origin of the FBS the use for culturing by comparing it with reference samples from low risk source countries, specifically New Zeland, the US and Australia.
Robert Curry, GE Healthcare senior product manager for cell culture serum, told us "Since FBS is derived from animals, the presence of virus and other infectious agents in serum is unavoidable and different countries of origin present different levels of risk of these agents being present.
"Consequently, the country of origin is of utmost priority“ he continued, adding "in addition, many manufactures have specific countries of origin written into their regulatory filing. "
Serum fraud
Serum from low risk countries – those where the icidence of bovine illnesses like mad cow disease and foot and mouth is low – is more expensive than countries where such diseases are more common.
This price difference "opens the door for fraud" according to Curry, who told us "to ensure that the raw sera are from the claimed origin, GE Healthcare has decided to put its sera products through a testing process that goes beyond industry standard practices.”
He explained that Oritain analyzes samples from global sources to create a fingerprint of origin that GE can use for comparative purposes.
The fingerprints “cannot be changed or tampered with in any way without detection as we are dealing with concentrations in the parts per million across over 20 different variables” Curry continued.
He went on to say the testing service will be available to all GE customers, explaining that: “We believe that all our customers will find this technology beneficial, but we envision this testing being a differentiator in Asia where serum fraud is more common.”