Home   |    Search

Important Terms to Know When Evaluating FBS

9CFR virus testing

Virus panel testing according to Code of Federal Regulations, (CFR), Title 9, Part 113.53 (c) [113.46, 113.47]. Detected by fluorescent antibody.

Biochemical and hormone profile

Quantification of biochemical and hormonal (estradiol, insulin, progesterone, testosterone, and thyroxine) profiling that may have impact on cell culture.

BSE status

BSE (bovine spongiform encephalopathy) is a disease for which the OIE (The World Organization for Animal Health) has established official recognition of the sanitary status of countries and zones. Regions that have negligible risk of bovine spongiform encephalopathy (mad cow disease) have lesser biosafety risk for import.

EMA virus testing

Virus panel testing according to Code of Federal Regulations, (CFR), Title 9, Part 113.53 (c) [113.46, 113.47]. Detected by fluorescent antibody.

Endotoxin testing

Endotoxin is directly related to the quality of collection and processing of serum, the higher the level, the more introduction to gram-negative bacteria.

Filtration

Triple (0.1 ┬Ám) filtration: Aseptic process that has been validated to ensure that all products meet the industry standard sterility assurance level of 10-3.

Haemoglobin/hemoglobin

Indicator of proper and/or improper collection and processing of blood and/or serum.

Mycoplasma and Mycoplasma supplemental testing (H-Stain)

Direct culture and Hoechst stain. Testing indicates Mycoplasma - Not Detected.

Origin confirmation

We use a proprietary fingerprinting technology to confirm FBS origin and eliminate the potential for counterfeit product.

Osmolality

Osmolality of FBS, a measure of the concentration of solutes like salts and sugars, should be similar to culture media to avoid osmotic shock that may impact cell viability.

Performance: relative growth promotion (RGP)

The growth promotion assay measures the ability of each FBS lot to support proliferation of fastidious human diploid fibroblasts through multiple subcultures.

pH: relative pH promotion

Serum acts as a buffer in the cell culture system; the pH is tested to ensure accurate cell culture quality and performance.

Total protein

FBS is rich in a variety of proteins that can impact cultured cells; the total protein in serum is measured by taking a chemistry panel of the serum.

_________________________________________________________________________________________________________________________________________________________________________________________________

Click here to see the previous section, Serum and Origin Definitions


Click here to see the next section, FBS Production & Testing

Join The ISIA Global Network Today