The ISIA traceability certification was awarded to Gibco by Thermo Fisher Scientific in 2014. This certification provides researchers with peace of mind and the confidence that Gibco sera are manufactured under the highest traceability standards.
Gibco sera provide researchers with transparency and confidence
Thermo Fisher Scientific offers Gibco sera that are ISIA Traceability Certified as well as fetal bovine serum (FBS) fingerprinting technology that provides empirical and statistical certainty over the origin and authenticity. Both traceability and fingerprinting give customers the transparency and confidence they demand from their FBS supplier. Since serum is the only ingredient in cell culture that is undefined, researchers are often convinced that when things go wrong, it’s the result of bad serum. Therefore, providing a reliable and trustworthy source of FBS is critical to helping ensure research success.
International Serum Industry Association (ISIA) traceability certification
What does traceability certification mean?
As a form of risk mitigation, the ISIA:
- Requires an independent third-party audit
- Covers identification and tracking of the product throughout every step of the process
- Grants certification based on the approved third-party audit
Thermo Fisher Scientific is committed to maintaining this certification and FBS quality:
- We maintain records of traceability from origin throughout the supply chain for all serum batches.
- We maintain the history for both quality and quantity of material, from point of collection through final processing.
- We retain the documentation supporting all stages of processing, transportation, and commercial transactions.
ISIA traceability certification diminishes the risk of using animal-derived materials in medical, science, and research industries.
The ISIA Traceability Program is not a required measure but a process that companies undergo willingly to certify serum traceability. ISIA approved and trained auditors will identify and report discrepancies from the first to the very last stage of FBS production, and review of records are required for certification. The ISIA ultimately endorses that product labels and descriptions are accurate and authentic.
Which FBS suppliers are certified by the International Serum Industry Association?
To learn more about whether your current FBS supplier is certified by ISIA, visit serumindustry.org.
Gibco FBS fingerprinting, powered by Oritain, provides reassurance regarding FBS origin
In partnership with Oritain, Gibco FBS fingerprinting helps ensure the quality of sera obtained from low viral risk regions. This technology measures the naturally occurring elements in the environment that are absorbed by plants, animals, and soils, and then compiles those measurements into a "fingerprint". Using this fingerprint, we can link serum to its specific geographical location—providing a robust means to verify if a product is genuine. Gibco sera are the first to be offered with this technology, giving scientists reassurance regarding the origin of each lot of serum.
Figure 1. Basis for FBS fingerprinting. Naturally occurring elements are absorbed by organisms, soil, and water. Levels of these elements vary geographically, meaning the concentrations found in natural products such as FBS are different depending on the environment where a source animal or plant was produced.
Figure 2. The collection process. (1) Product samples are collected. (2) Samples are analyzed to determine fingerprints. (3) Fingerprints are stored in a database and are ready to audit against “suspect” samples.
FBS origin analysis graphs
Figure 3. Statistical representation of the chemical fingerprint of origin for Australian, Brazilian, Mexican, New Zealand, and USA derived Fetal Bovine Serum. Each 3D graph is a different perspective of the same data set. Lot # described in this report is labeled with a black star.
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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