GE Healthcare and Oritain are today launching an independent test-based traceability program to authenticate the country of origin of Fetal Bovine Serum (FBS). 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.
Morgan Norris, General Manager for Upstream and Cell Culture, GE Healthcare Life Sciences, says that the country of origin is important – especially when FBS is used in biomanufacturing. “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,” he says.
GE Healthcare is already traceability-certified by the International Serum Industry Association (ISIA), but to ensure that premium raw serum from Australia, New Zealand and the United States is indeed from that country of origin, GE will now put its sera products through a testing process that goes beyond industry-standard traceability practices.
“FBS is used to manufacture vaccines that protect people from a variety diseases. We want to ensure that our customers can access high-quality products with the lowest risk possible when producing their vaccines and biopharmaceuticals. This test-based traceability is another tool we have to assure this,” says Norris. “By partnering with Oritain, we are committing to supply our customers with products of exceptional quality and integrity,” he says.
With GE’s new testing program, Oritain will perform independent testing of batch samples of FBS from Australia, New Zealand and the United States. Customers will then be able to retrieve an independent verification certificate linked to the serum lot that they have purchased, by entering the lot number found on the bottle marked with Oritain’s proprietary Trustmark and QR code on this website: http://oritain.com/gehealthcare/
Oritain CEO Grant Cochrane says that Oritain’s Scientific Traceability method is unique in the fact that it does not rely on paper or labels, but rather authenticates the origin of the product itself. “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 analyzed 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,” says Cochrane.
“We are delighted to be providing proof of origin services for these GE Healthcare products that are making the world a safer and healthier place. Oritain’s country of origin verification service for FBS products means greater authenticity and trust for GE’s clients, as it minimizes the likelihood of product fraud or counterfeiting in the supply chain in high-risk countries,” says Cochrane.