FBS & Global Biological Risk


You may be familiar with the terms “traceability” and “origin” in reference to fetal bovine serum (FBS), but how do these topics really impact the use of serum in cell culture? “Origin” is simply the country in which the raw material was collected. “Traceability” refers to the documentation roadmap that connects serum origin to final manufacturing and distribution.

So, why is origin important?

As viral patterns shift around the globe, the supply and quality of bovine products such as FBS are affected. One of the most recent issues to alter the global supply‐and‐ demand dynamic is Bovine Spongiform Encephalopathy (BSE), more commonly known as “mad cow disease.” BSE is a chronic, degenerative disease affecting the central nervous system of cattle. The United States Department of Agriculture (USDA) only permits the importation of bovine products from those countries that are considered to be at low risk for BSE. The spread of BSE, therefore, limits the global supply of FBS, driving up demand for serum from the low‐risk countries and linking FBS prices to perceived BSE risk; the lower the BSE risk, the higher the cost of serum.

Where is the risk?

Some countries, such as those within the European Union, are considered to present a very high risk of BSE and are not allowed to import bovine products into the United States. On the other end of the spectrum are those countries that present no demonstrable risk at all. For example, New Zealand has never reported a single case of BSE. Due, in part, to its geographic isolation, New Zealand is perceived to be the safest current source for FBS.

As indicated on the map above, the Food and Agriculture Organization of the United Nations recognizes for risk categories for BSE:

  1. Negligible Risk
  2. Controlled Risk
  3. Unknown Risk

Gemini Bio‐Products sources all fetal bovine serum from the “Negligible Risk” category. Our GemCell™ US Origin FBS comes exclusively from the United States, while our other FBS products (such as BenchMark™ and Foundation™) are also sourced from countries considered “negligible risk”. Well‐documented traceability ensures the lowest risk.

Gemini collects raw serum only from countries that have been declared by the USDA to be free of specified bovine viruses, such as BSE. Each lot of our fetal bovine serum is fully documented and certified as to its country of origin. We work in close cooperation with the USDA to monitor FBS health and quality, employing an aggressive viral testing scheme to deliver only the safest and most well‐characterized products to our customers.

For more than thirty years, Gemini Bio‐Products has delivered culture with exceptional value.