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 this list of common FBS terms and definitions together to help ease ​your search.

• Adult Bovine Serum – Serum derived from blood of healthy, slaughtered cattle 12 months of 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 mature animals from controlled herds whose health status is confirmed by regular inspection by legally authorized veterinarians.
  
• EDQM – European Directorate for the Quality of Medicines.
  
• Filtered Serum/Serum Product – This is semi-processed serum that has been thawed, pooled, mixed up 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 in 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 but may not be suitable for clinical or diagnostic use.
  
• Good Manufacturing Practices – Requirements related to the methods, facilities, and controls used for design, manufacture, packaging, labeling, storage, installation 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 completed devices that consist of a single type, model class, or size composition that are manufactured under essentially the same conditions, and that are intended to have uniform characteristic and quality within specific limits.
  
• Newborn Bovine (Calf) Serum (NBCS) – Serum derived from blood of healthy, slaughtered calves less than 20 days old.
  
• Plasma – The fluid fraction of un-clotted blood.
  
• Raw or Semi-Processed Serum – Serum prepared using a centrifuging so that the clot and blood cells are separated from the liquid. The serum is then frozen pending additional processing.
  
• Serum – The clear to yellowish fluid obtained by separating clotted blood that is depleted of cells, fibrin, and clotting factors.
  
• Trade Control and Expert System (TRACES) –A veterinarian certification tool used by the European Union for controlling the import, export, and trade of live animals and animal products.
  
• Whole Blood – 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!