In the manufacture of viral vaccines, the virus may be grown in cells. During immunohistochemistry, which is the process that uses antibodies to identify antigens in cells, tissue sections are often incubated with BSA blockers to bind nonspecific binding sites. However, FDA wants to minimize any chance that the BSE agent could be introduced into biologic products during manufacture. BSA has numerous biochemical applications including ELISAs (Enzyme-Linked Immunosorbent Assay), immunoblots, and immunohistochemistry. 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. CBER inspects vaccine manufacturers on a routine basis to determine whether sourcing and documentation are consistent with current recommendations contained in letters and guidance documents. Bovine serum is filtered through 0.2 µm filters.
The growth promotion assay measures the ability of each FBS lot to support proliferation of fastidious human diploid fibroblasts through multiple subcultures.
Testing indicates Mycoplasma - Not Detected. How did the FDA discover that some manufacturers are not universally following letters, Points to Consider (PTC) and guidance documents? Refer to our in-depth guides below to learn more about FBS collection, applications, and more.
The color does not affect the FBS performance. It is collected in abattoirs inspected by the competent authority of the country of origin.
FBS contains growth factors and very low levels of antibodies, allowing for versatility in many different cell culture applications. Use a calibrated thermometer only! This is semi-processed FBS or sterile filtered FBS that has been subjected to one or more modification processes. In December 1993 and May 1996 FDA issued letters advising that bovine derived materials from animals born in or residing in countries where BSE had occurred should not be used to manufacture FDA-regulated products intended for administration to humans. Collection occurs in an area of the abattoir specifically set aside for this purpose to minimize the risk of contamination by other fluids.
Serum is the liquid fraction of clotted blood.
Indicator of proper and/or improper collection and processing of blood and/or serum. Fetal bovine serum (FBS) provides the most robust culture system for the widest range of cell types both cell lines and primary cells.
The price and availability of FBS can be difficult to predict. We use a proprietary sera fingerprinting technology for Gibco sera to confirm FBS origin and eliminate the potential for counterfeit product.
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This is a normal characteristic of FBS, especially heat-inactivated FBS, and will not affect product performance.
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.
In the late 19th century, microbiologists began to grow bacteria in the laboratory. Before sharing sensitive information, make sure you're on a federal government site.
What measures have the FDA taken to ensure that people are not exposed to the BSE agent in vaccines?
Nutrients and energy sources necessary for growth, Buffering capacity/protection – pH shifts, proteases, toxins, Typically used at a concentration of 5–10% in a basal medium, FBS composition is undefined, and varies from lot-to-lot, Agents that would typically break up monolayers of adherent cells (FBS acts to inactivate these agents), Lacking in undesirable changes in differentiation, Not hampered by the introduction of detrimental contaminants.