Definitions of common FBS terms

If you’re new to using Fetal Bovine Serum (FBS), some of the terms in the industry may be overwhelming or confusing. We’ve put together this list of common FBS terms and definitions to help make your search easier.

• Adult Bovine Serum – Serum derived from blood of healthy, slaughtered cattle 12 months or age or older.
• Certificate of Suitability – The role of the Certificate of Suitability is to ensure that bovine serum products meet the requirements to satisfy relevant monograph of the European Pharmacopoeia for medicinal products for human or veterinary use.
• Donor Bovine Serum – Serum derived from adult bovines of controlled hears whose health status is confirmed by regular inspection by competent, legally authorized veterinarians.
• EDQM – European Directorate for the Quality of Medicines.
• Filtered Serum/Serum Product – Semi-processed serum that has been thawed, pooled, mixed to create uniformity, and subjected to filtration before being aseptically dispensed into final packaging and appropriately labeled for distribution.
• For Further Manufacturing Use – Serum used for processing or manufacturing of another drug or device for clinical or diagnostic use.
• For Research Use – Serum Intended for use in the conduct of research on not approved for clinical or diagnostic use.
• Good Manufacturing Practices – Requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.
• In Vitro Diagnostic Products – Regents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
• Lot or Batch – One or more components or finished devices that consist of a single type, model class, size composition that are manufactured under essentially the same conditions and that are intended to have uniform characteristic and quality within specified limits.
• Newborn Bovine (Calf) Serum (NBCS) – Serum derived from blood of healthy, slaughtered bovine claves less than 20 days old.
• Plasma – The liquid fraction of un-clotted blood.
• Raw or Semi-Processed Serum – Prepared by centrifuging until the clot and remaining blood cells are separated from the liquid phase. The collected serum is then stored frozen pending further processing.
• Serum – The clear yellowish fluid obtained upon separating clotted blood that is depleted of cells, fibrin and clotting factors.
• Trade Control and Expert System (TRACES) – A trans-European network for veterinary health which notifies, certifies and monitors imports, exports and trade in animal and animal products.
• Whole Blood – Collected blood, in which none of the elements have been removed.

If you run into any other common FBS terms you have questions about, please don’t hesitate to reach out. We’re here to help!