Fetal bovine serum (FBS) is the light-brown liquid fraction of clotted fetal bovine blood. It is depleted of cells, fibrin, and clotting factors. Although the complete composition of FBS is undefined, FBS contains high levels of growth factors and low levels of immunoglobulins. In addition, it contains other key ingredients that are essential in supporting proliferation of cells in culture. This product is used both in life science basic research and industrial manufacturing. FBS is a by-product of the meat industry and is collected from bovine fetuses removed from cattle found to be pregnant at slaughter. FBS is harvested from abattoirs that are inspected by the competent authority in the country of origin. Trained personnel following written and approved procedures should perform collection and processing. Blood is collected in a closed system in a dedicated area within the facility, and processed quickly to prevent hemolysis. The blood is allowed to clot and then typically is centrifuged in a refrigerated centrifuge to separate the serum from the other components. Serum typically is removed from the clot, transferred to labeled containers, and frozen. All manufacturers employ sterile filtration before final packaging. Additionally, gamma irradiation provides the highest assurance of the abs ence of viral activity. Gamma irradiation doses of 25–40 kGy provide significant log reduction of viral and other adventitious agents while preserving cellular growth performance.
The screening of FBS for viral contamination is accomplished by using all applicable testing described in the Code of Federal Regulations 9 CFR 113.53 (known as full 9 CFR testing). Mycoplasma assays are performed as described in Mycoplasma Tests 〈63〉.
IDENTIFICATION
•Identification—Radial Immunodiffusion
Reagents
FBS test samples
Horse serum, negative control samples
Bovine IgG calibrator (500 mg/L)
Sheep albumin diluent (1% Sheep albumin, 0.18% EDTA, 1.75% NaCl, and 1.21% Tris/HCl pH 7.4).
Source from USP and Please refer to USP for details:
RTU(ready to use) 2ml COP vial
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