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Fetal Bovine Serum Collection and Manufacturing
Where does fetal bovine serum come from?
Fetal bovine serum (FBS) is sourced from bovine fetuses as a byproduct of the meatpacking industry. To ensure safety and quality, FBS can only be drawn in licensed facilities and in aseptic conditions that meet federal regulations.
Gibco FBS—extraordinary measures and exceptional standards for FBS production
Wondering how Gibco fetal bovine serum is extracted and the measures taken to ensure quality during fetal bovine serum production? Being vertically integrated, Thermo Fisher Scientific has full oversight of the FBS collection process in most countries. Whereas other companies often utilize a third party for the initial steps of the extraction and collection process, Thermo Fisher prioritizes having this oversight from “farm to bench.”
Follow the step-by-step journey of Gibco sera manufacturing, so you can learn what sets Thermo Fisher apart as an FBS manufacturer.
How is FBS collected?
 | Gibco FBS is collected from government-approved facilities with clinically examined healthy animals under veterinary supervision, using only the strictest aseptic collection techniques. Cows pass both veterinary pre- and post-mortem inspections. During extraction, blood is drawn via cardiac puncture from the expired fetus in a closed system using best practices to regulate hemoglobin and endotoxin levels. Blood is refrigerated to encourage clotting and processed into raw serum. |
Extraordinary measure: Unlike most FBS suppliers, we invest in Thermo Fisher Scientific FBS collectors, who obtain the majority of our supply straight from the collection site.
 | The FBS is immediately packed on ice and kept at an ideal temperature, then shipped to quality audited processing facilities. |
Extraordinary measure: Our innovative process provides a completely closed system, blocking all air exposure to help ensure low levels of endotoxin and hemoglobin.
Did you know...
Thermo Fisher Scientific was the first global serum provider to be awarded the International Serum Industry Association Traceability certification , which requires rigorous records of the origin and quality of FBS throughout the entire supply chain starting at the collection phase.
How is FBS processed?
| At processing facilities, numerous quality checks, such as testing hemoglobin levels, are conducted to ensure that the integrity of the product is maintained. |
Extraordinary measure: We continuously monitor the temperature throughout the process to maintain product integrity.
| Blood and sera are centrifuged multiple times to the lowest hemoglobin levels. |
 | Frozen serum is transported to the next facility in a freezer truck and stored in large walk-in freezers. |
Did you know...
The Gibco brand was the first serum to utilize FBS fingerprinting technology, powered by Oritain . We can now measure elements in our source regions to create a unique "fingerprint" for every batch of Gibco FBS, verifying that each product is genuine.
What are the final steps of fetal bovine serum production?
| Raw serum is thawed overnight in a temperature-controlled thaw room to minimize bacteria buildup. |
| FBS is transferred to a clean room for sterile filtration. |
Extraordinary measure: Gibco serum is manufactured in its country of origin whenever feasible, to avoid any possible risk of cross-contamination. Furthermore, processed Gibco FBS is never blended from different origins.
Note: While filter pores can remove fungi and bacteria, they are unable to eradicate viruses. Therefore, each batch is viral tested. Depending on customer requirements, the serum may be gamma irradiated to deactivate viral load.
| FBS is tested before clearing quality checks (QC) and being packaged for shipment. |
Extraordinary measure: We provide Gibco FBS in innovative packaging like the ergonomically designed 500 mL bottle and the aliquot-free One Shot FBS 50 mL bottle.
Did you know...
Gibco FBS is transferred to the clean room in specially designed stainless steel pipes where it then undergoes 0.1 μm triple filtration to eradicate biological contaminants.
How is FBS collected?
| Gibco FBS is collected from government-approved facilities with clinically examined healthy animals under veterinary supervision, using only the strictest aseptic collection techniques. Cows pass both veterinary pre- and post-mortem inspections. During extraction, blood is drawn via cardiac puncture from the expired fetus in a closed system using best practices to regulate hemoglobin and endotoxin levels. Blood is refrigerated to encourage clotting and processed into raw serum. |
Extraordinary measure: Unlike most FBS suppliers, we invest in Thermo Fisher Scientific FBS collectors, who obtain the majority of our supply straight from the collection site.
| The FBS is immediately packed on ice and kept at an ideal temperature, then shipped to quality audited processing facilities. |
Extraordinary measure: Our innovative process provides a completely closed system, blocking all air exposure to help ensure low levels of endotoxin and hemoglobin.
Did you know...
Thermo Fisher Scientific was the first global serum provider to be awarded the International Serum Industry Association Traceability certification , which requires rigorous records of the origin and quality of FBS throughout the entire supply chain starting at the collection phase.
How is FBS processed?
| At processing facilities, numerous quality checks, such as testing hemoglobin levels, are conducted to ensure that the integrity of the product is maintained. |
Extraordinary measure: We continuously monitor the temperature throughout the process to maintain product integrity.
| Blood and sera are centrifuged multiple times to the lowest hemoglobin levels. |
| Frozen serum is transported to the next facility in a freezer truck and stored in large walk-in freezers. |
Did you know...
The Gibco brand was the first serum to utilize FBS fingerprinting technology, powered by Oritain . We can now measure elements in our source regions to create a unique "fingerprint" for every batch of Gibco FBS, verifying that each product is genuine.
What are the final steps of fetal bovine serum production?
| Raw serum is thawed overnight in a temperature-controlled thaw room to minimize bacteria buildup. |
| FBS is transferred to a clean room for sterile filtration. |
Extraordinary measure: Gibco serum is manufactured in its country of origin whenever feasible, to avoid any possible risk of cross-contamination. Furthermore, processed Gibco FBS is never blended from different origins.
Note: While filter pores can remove fungi and bacteria, they are unable to eradicate viruses. Therefore, each batch is viral tested. Depending on customer requirements, the serum may be gamma irradiated to deactivate viral load.
| FBS is tested before clearing quality checks (QC) and being packaged for shipment. |
Extraordinary measure: We provide Gibco FBS in innovative packaging like the ergonomically designed 500 mL bottle and the aliquot-free One Shot FBS 50 mL bottle.
Did you know...
Gibco FBS is transferred to the clean room in specially designed stainless steel pipes where it then undergoes 0.1 μm triple filtration to eradicate biological contaminants.
How much serum is produced during fetal bovine serum extraction?
The age and size of the bovine fetus determine the amount of FBS that can be produced.
- A 3-month-old fetus yields approximately 150 mL of raw FBS.
- A 6-month-old fetus yields approximately 350 mL of raw FBS.
- A 9-month-old fetus yields approximately 550 mL of raw FBS.
Approximately 500,000 L of FBS are produced annually, requiring the harvest of about one million bovine fetuses [1].
Examples of quality tests performed during FBS production
Processing and quality testing are vital to ensuring that FBS is suitable for cell culture. These steps can be particularly extensive depending on the intended use and required testing of the FBS.
Examples of FBS quality tests conducted include:
- Endotoxin testing
- Hemoglobin
- Mycoplasma testing
- Osmolality
- Performance (growth)
- Total protein
- 9CFR virus testing
- EMA virus testing (on selected lots)
Each stage of FBS treatment is stringently documented for every batch, but customers are also able to test products prior to purchasing. Based on application, additional tests may be conducted.
There are also several special treatments that sera may undergo:
- Charcoal treatment—activated carbon binds to lipophilic molecules and is used to remove hormones (e.g., androgen, cortisol, estradiol, testosterone, etc.) that often impede immunoassay systems and insulin examination procedures.
- Dialysis—removes any molecule with a molecular weight less than 10,000, including antibiotics, amino acids, cytokines, glucose, and hormones.
- Heat inactivation—by placing FBS in a water bath at 56°C for 30 minutes, inhibitors are deactivated. However, this is not a recommended treatment for most cell cultures since it can disable growth factors and may cause precipitates to form.
- Treatment to lower IgG—capture chromatography can significantly decrease IgG content.
Who regulates fetal bovine serum collection and manufacturing?
 | Government agencies (DEFRA, USDA, MPI, DAWR, etc.) set standards for the animal sera industry’s requirements and regulations for the global import and export of animal byproducts. |
However, certain geographical regions have varying levels of viral risk. FBS imported from Canada and New Zealand into the US, for instance, require no further safety testing by the USDA. On the other hand, Australian sourced FBS must be tested for two viruses, Akabane and Bluetongue. Mexican and Central American FBS also require USDA safety testing for Bluetongue upon import into the US.
International Serum Industry Association (ISIA) regulation
In addition to government agencies, the International Serum Industry Association (ISIA) was established in 2006 to regulate the animal serum industry and focuses on four key areas:
- Education—to inform animal serum users and producers
- Regulation—to assist in the development of governance of the industry
- Standardization—to systematize import/export, standards, and testing methodology
- Traceability—to improve and promote the ISIA Traceability Program [2]
Effective February 12, 2014, ISIA traceability certification was awarded to Thermo Fisher Scientific for Gibco FBS.
Fingerprinting technology
FBS fingerprinting technology is another innovative method being utilized to push transparency in the sera collection and distribution process. Produced by Oritain, fetal bovine serum fingerprinting technology takes the measurements of natural elements absorbed by animals, plants, and soil, and then constructs a fingerprint that allows for verification of each serum’s origin.
Discover how Gibco FBS fingerprinting powered by Oritain is helping to assure product authenticity
Standards of FBS production for medicinal and pharmaceutical purposes
| When animal sera are intended for use in pharmaceutical production or medicinal merchandise, testing and requirements become more rigorous. Robust Quality Management Systems (QMS) and following current Good Manufacturing Practices (cGMP) are required to meet the serum industry standards. GMP is an elaborate system of stipulations that exist to promote products of the highest quality, especially concentrated on raw materials like FBS. |
References
Resources
Fetal Bovine Serum Basics
Learn the basics of FBS for cell culture, including information on the FBS uses, components, and the market dynamics driving this industry.
Cell Culture Basics
Learn the fundamentals of cell culture for achieving consistent results, including laboratory setup, safety, and aseptic techniques.
Gibco iMatch Sera Lot Matching Tool
Provide your previous Gibco FBS lot number or answer a few questions to find your ideal serum match.
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