Serum and Origin Definitions

Serum

Serum is the liquid fraction of clotted blood. It is depleted of cells, fibrin and clotting factors. Serum differs from plasma in that anti-coagulant is never added to the blood after collection from the animal. Serum is prepared by centrifuging until the clot and remaining blood cells are separated from the liquid phase. The serum is then removed and stored frozen pending further processing.

Fetal Bovine Serum

Semi-processed or raw Fetal bovine serum (FBS) is obtained as described above from the blood of fetuses of healthy, pre-partum bovine dams that have been subjected to ante and/or post-mortem veterinary inspection. It is collected in abattoirs inspected by the competent authority in the country of origin. Fetal blood is collected aseptically using cardiac puncture, thereby reducing the risk of microbial contamination and resultant endotoxins. Collection occurs in an area of the abattoir specifically set aside for this purpose to minimize the risk of contamination by other fluids.  There are no deletions or additions (including preservatives) allowed.

Specialty Fetal Bovine Serum

This is semi-processed FBS or sterile filtered FBS that has been subjected to one or more modification processes. Examples are Dialyzed, Charcoal Stripped, Ultra-low IgG, ES Cell, MSC and Exosome-Depleted.

Newborn Calf Serum

Newborn Calf Serum (NBCS) is defined as the liquid fraction of clotted blood derived from healthy, slaughtered bovine calves aged less than 20 days, deemed fit for human consumption through ante- and/or post- mortem inspection. It is collected in abattoirs inspected by the competent authority of the country of origin. There are no deletions or additions (including preservatives) allowed.

Donor Bovine Serum            (also known Donor Calf              Serum)

Donor-sourced Bovine Serum (DBS) is defined as the liquid fraction of clotted blood derived from healthy cattle 12 months of age or older from controlled donor herds whose health status is confirmed by regular inspection by competent, legally authorized veterinarians.

Bovine Serum                            (also known as Adult Bovine    or Calf Serum)

Bovine Serum is defined as the liquid fraction of clotted blood derived from healthy, slaughtered cattle 12 months of age or older, deemed to be fit for human consumption by ante- and/or post- mortem inspection. It is collected in abattoirs inspected by the competent authority of the country of origin.

Country of Collection

This is the country where the animal was slaughtered and the blood was collected or, in the case of donor animals, where the blood was collected. This includes animals born and raised in the country of collection, as well as imported animals, and may include animals imported for immediate slaughter. This is the country shown on the label as “origin”. The Country of Collection is required to be shown on the Certificate of Analysis (CoA) and Certificate of Origin (CoO). The process of collecting blood and separating serum is considered substantial transformation.

Country of Manufacturing

This is the country where filtration, bottling, and labeling occur and includes any other processes performed prior to filtration and bottling. Other acceptable terms include “Manufacturing Address” or “Site of Manufacture”. This should be listed on the CoA. This is not considered substantial transformation.

Country of Further Treatment

This is the country in which the product is treated after sterile filtration. Examples of further treatment are gamma irradiation or heat inactivation.  These processes should be listed individually on the CoA and are not considered substantial transformation.