GE Healthcare Life Sciences and Oritain have launched an independent traceability test to authenticate the country of origin of foetal bovine serum
FBS is used in basic research and drug discovery
Foetal bovine serum (FBS) is a cell growth supplement used in the manufacture of biopharmaceuticals and vaccines for human health and veterinary purposes, it is also used 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.
Morgan Norris, General Manager for Upstream and Cell Culture at GE Healthcare, said: “Different countries of origin present different risk levels for a range of virus contamination and using serum that we know to be from low risk countries is a top priority for our clients.
FBS is used to manufacture vaccines that protect people from a variety of diseases. We want to ensure that our customers can access high-quality products with the lowest risk possible when producing their vaccines and biopharmaceuticals.
GE Healthcare is traceability certified by the International Serum Industry Association (ISIA), but to ensure premium raw serum from Australia, New Zealand and the US, is in fact from the stated country of origin, GE will now put its sera products through a testing process, which goes beyond industry standard traceability practices.
Oritain will perform independent testing of batch samples of FBS from Australia, New Zealand and the US, as part of GE’s new testing programme.
Customers will then be able to retrieve an independent verification certificate linked to the serum lot they have purchased, by entering the lot number found on the bottle marked with Oritain’s proprietary Trustmark and QR code, click here for the website
Grant Cochrane, CEO of Oritain, said: “Scientific Traceability measures the naturally occurring chemical elements that exist within the serum itself as a result of the particular environment the cows are being raised in.
"With FBS samples obtained from GE manufacturing sites all over the world, we have analysed each one to create a unique fingerprint of origin for sera that comes from the USA, Australia and New Zealand. This cannot be changed or tampered with in any way without detection, as we are dealing with concentrations in the parts per million across more than 20 different variables.”