August 2026 · 6 min read
When you order FBS, the supplier will tell you it is “South American origin” — 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.
Why origin matters — the TSE/BSE risk framework
Transmissible spongiform encephalopathies (TSEs) — including BSE (bovine spongiform encephalopathy, “mad cow disease”) — 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.
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.
BSE risk by FBS origin country
| Origin Region / Country | OIE BSE Status | Regulatory risk rating | Standard for FBS? |
|---|---|---|---|
| Brazil | Negligible BSE risk (OIE certified) | Lowest risk — preferred by EMA | Yes — primary global source |
| Argentinien | Negligible BSE risk | Lowest risk | Yes — major source |
| Uruguay | Negligible BSE risk | Lowest risk | Yes — significant source |
| Chile | Negligible BSE risk | Lowest risk | Yes — available on request |
| Australia / New Zealand | Negligible BSE risk | Lowest risk | Yes — premium pricing, available on request |
| Vereinigte Staaten | Controlled BSE risk | Moderate — documented low incidence | Yes — USDA permit required for EU import |
| Mexiko | Negligible BSE risk | Lowest risk | Yes — available on request |
| Western Europe (UK, Germany, France etc.) | Controlled or undetermined BSE risk | Higher risk — requires additional documentation | Rarely — not standard for FBS production |
Why South America dominates FBS production
South America — primarily Brazil, Argentina, and Uruguay — produces approximately 70–80% of the world’s FBS for three reasons:
- Cattle population: 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.
- BSE history: 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.
- Cost: 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.
Is Australian or New Zealand FBS “better”?
Australia and New Zealand FBS carries the same OIE negligible BSE risk status as South American material — from a regulatory risk perspective, they are equivalent. The practical difference is price (Australian FBS is typically 20–40% more expensive) and availability (smaller cattle populations limit production volume).
Australian FBS is occasionally preferred for specific regulatory submissions where auditors historically preferred it — 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.
What origin documentation should your CoA contain?
A complete origin documentation package for FBS should include:
- Certificate of Origin (CoO): Specifies the country of blood collection
- TSE/BSE statement: Confirms OIE risk category of the country of origin at the time of collection
- Slaughterhouse certification: USDA or local authority registration of the collection facility
- Species declaration: Confirms bovine origin (relevant for mixed-species processing facilities)
- USDA import permit documentation: Required for FBS imported into the US; relevant for EU manufacturers exporting to the US market
All SeamlessBio FBS is South American origin (Brazil, Argentina, Uruguay) as standard — OIE negligible BSE risk certified. Alternative origins (Australia, US, Mexico, Chile, New Zealand) available on request. Full origin documentation package included with every lot shipment.
What SeamlessBio supplies
- Standard: South American origin (Brazil/Argentina/Uruguay)
- On request: Australian, New Zealand, US, Mexican, Chilean origin
- Processing and QC: Biophyll GmbH, Dietersburg, Germany
- Documentation: CoA, CoO, TSE/BSE statement, sterility, mycoplasma, endotoxin, viral panel
→ View FBS Portfolio | → Request documentation package
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