{"id":2872,"date":"2026-08-21T21:07:52","date_gmt":"2026-08-21T20:07:52","guid":{"rendered":"https:\/\/seamlessbio.de\/?p=2872"},"modified":"2026-08-21T21:07:55","modified_gmt":"2026-08-21T20:07:55","slug":"fbs-south-american-origin-tse-bse-guide","status":"publish","type":"post","link":"https:\/\/seamlessbio.de\/de\/fbs-south-american-origin-tse-bse-guide\/","title":{"rendered":"FBS South American Origin"},"content":{"rendered":"

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August 2026 \u00b7 6 min read<\/em><\/p>\n

When you order FBS, the supplier will tell you it is “South American origin” \u2014 and for most applications, that is the end of the conversation. But if you are developing a GMP process, submitting an IND, or simply want to understand what origin actually means for your risk assessment, here is what you need to know.<\/p>\n

Why origin matters \u2014 the TSE\/BSE risk framework<\/h2>\n

Transmissible spongiform encephalopathies (TSEs) \u2014 including BSE (bovine spongiform encephalopathy, “mad cow disease”) \u2014 are prion diseases. Prions are misfolded proteins that are not inactivated by standard sterilisation methods including autoclaving, gamma irradiation, or filtration. A country’s BSE status is therefore the primary determinant of TSE risk in bovine-derived biological materials.<\/p>\n

The European Medicines Agency (EMA) and FDA assess BSE risk in bovine materials based on the country of origin’s OIE (World Organisation for Animal Health) BSE status classification. Countries with historically higher BSE incidence (primarily Western Europe in the 1990s) carry higher risk ratings. Countries with no documented or minimal BSE cases carry lower risk ratings.<\/p>\n

BSE risk by FBS origin country<\/h2>\n\n\n\n\n\n\n\n\n\n\n
Origin Region \/ Country<\/th>\nOIE BSE Status<\/th>\nRegulatory risk rating<\/th>\nStandard for FBS?<\/th>\n<\/tr>\n
Brazil<\/strong><\/td>\nNegligible BSE risk (OIE certified)<\/td>\nLowest risk \u2014 preferred by EMA<\/td>\nYes \u2014 primary global source<\/td>\n<\/tr>\n
Argentinien<\/strong><\/td>\nNegligible BSE risk<\/td>\nLowest risk<\/td>\nYes \u2014 major source<\/td>\n<\/tr>\n
Uruguay<\/strong><\/td>\nNegligible BSE risk<\/td>\nLowest risk<\/td>\nYes \u2014 significant source<\/td>\n<\/tr>\n
Chile<\/strong><\/td>\nNegligible BSE risk<\/td>\nLowest risk<\/td>\nYes \u2014 available on request<\/td>\n<\/tr>\n
Australia \/ New Zealand<\/strong><\/td>\nNegligible BSE risk<\/td>\nLowest risk<\/td>\nYes \u2014 premium pricing, available on request<\/td>\n<\/tr>\n
Vereinigte Staaten<\/strong><\/td>\nControlled BSE risk<\/td>\nModerate \u2014 documented low incidence<\/td>\nYes \u2014 USDA permit required for EU import<\/td>\n<\/tr>\n
Mexiko<\/strong><\/td>\nNegligible BSE risk<\/td>\nLowest risk<\/td>\nYes \u2014 available on request<\/td>\n<\/tr>\n
Western Europe (UK, Germany, France etc.)<\/strong><\/td>\nControlled or undetermined BSE risk<\/td>\nHigher risk \u2014 requires additional documentation<\/td>\nRarely \u2014 not standard for FBS production<\/td>\n<\/tr>\n<\/table>\n

Why South America dominates FBS production<\/h2>\n

South America \u2014 primarily Brazil, Argentina, and Uruguay \u2014 produces approximately 70\u201380% of the world’s FBS for three reasons:<\/p>\n

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  1. Cattle population:<\/strong> Brazil has the world’s largest commercial cattle herd (>220 million head) and a massive slaughter industry, providing the volume of foetal blood needed for FBS production at scale.<\/li>\n
  2. BSE history:<\/strong> South American cattle populations were not exposed to the meat-and-bone meal feeding practices that caused the BSE epidemic in Europe. OIE-certified negligible BSE risk status makes South American FBS the lowest-risk option for regulatory submissions.<\/li>\n
  3. Cost:<\/strong> The combination of large cattle populations, established processing infrastructure, and lower labour costs makes South American FBS price-competitive relative to Australian or US-origin material.<\/li>\n<\/ol>\n

    Is Australian or New Zealand FBS “better”?<\/h2>\n

    Australia and New Zealand FBS carries the same OIE negligible BSE risk status as South American material \u2014 from a regulatory risk perspective, they are equivalent. The practical difference is price (Australian FBS is typically 20\u201340% more expensive) and availability (smaller cattle populations limit production volume).<\/p>\n

    Australian FBS is occasionally preferred for specific regulatory submissions where auditors historically preferred it \u2014 but this preference is not based on a documented risk difference and is becoming less common as South American BSE certification has strengthened over the past decade.<\/p>\n

    What origin documentation should your CoA contain?<\/h2>\n

    A complete origin documentation package for FBS should include:<\/p>\n