Did You Know?

 The ISIA traceability audit is tailored and customized to the individual company’s processes.  The audit includes:

• Review sourcing documentation

• Assessing chain-of-custody records to include mass balance verification

• Reviewing compliance with industry standards and regulations

• Random sampling of serum by the auditor for geographic testing

Geographic testing for fetal bovine serum (FBS) is a chemical analysis method that uses trace elements to verify the geographic origin of a serum product. The International Serum Industry Association (ISIA) developed this method in partnership with Oritain Global Limited to support their traceability program. The database created by this partnership can identify serum from many geographies. 

While the country of origin can be a factor in regulatory requirements, the quality of FBS is not necessarily tied to its geographic origin. The quality of FBS is more dependent on how it's collected, processed, and tested. High-quality FBS can come from any country as long as it meets regulatory and industry standards. 

Some factors that can impact the availability and price of FBS include:

• Animal health: The risk of infectious diseases and the health status of animals in the country of origin can impact the availability of FBS.

• Global events: Weather events can make it difficult for farmers to manage animal husbandry, which can impact the supply of FBS.

• Demand: The global demand for FBS, a finite resource, increases year after year.

Learn more about our partnership and the testing process in the ISIA/Oritain whitepaper.