Is Fetal Bovine Serum Used in Vaccines?
What is Fetal Bovine Serum (FBS)?
Due to its high concentration of factors that promote embryonic growth, foetal bovine serum (FBS) is the most often utilised growth supplement for cell culture media. It provides a variety of known and unknown substances that, when used at the right concentrations, have been demonstrated to meet unique metabolic requirements for cell culture. Growth factors, proteins, trace elements, vitamins, and hormones are all included in the complex mixture of biomolecules that makes up FBS. Both in vivo and culture, are crucial for the growth and upkeep of cells.
How do you use FBS?
Fetal bovine serum is used for a variety of purposes. The field of bio pharmaceuticals and vaccines is the most significant. It is utilised in the discovery, production, and control of numerous cutting-edge pharmaceuticals as well as human and veterinary vaccines.
Numerous studies also make use of foetal bovine serum. Bovine serum is frequently utilised in the production of bio-pharmaceuticals, including vaccinations, using a method known as "Cell culture."
How is FBS obtained?
FBS is obtained from the foetuses of pregnant cows that have been slaughtered following international veterinary inspection standards and OIE (World Animal Health Organization) regulations.
In essence, FBS is a natural product. Every FBS batch has distinctive qualities that set it apart from other batches.
However, FBS is becoming less and less accessible. Prices for meat and calves are rising as beef consumption rises in some nations and cattle breeding methods continue to advance. Fewer pregnant cows are being slaughtered as a result of these combined reasons. For many years, the collection of FBS in new countries offset the decline in supply; however, there are no longer any new producer nations accessible. FBS is currently in short supply and will continue to decline.
Cell growth and FBS
Cell growth is unaffected by the source of the serum. Biowest studied cell growth in FBS from seven different nations across three continents and found that all cell lines tested had the same average performance regardless of the nation of origin. For one particular cell line, one batch of FBS might be effective, but not for another. Each cell line has a unique "serum quality." Because of this, analysing FBS is frequently done while working with delicate cell lines. Biowest conducts the industry's most thorough analyses of biochemical variables and tests on cell lines, publishing the results on Certificates of Analysis.
Country where the serum comes from is bound to receive USDA approval. This indicates that serum is made from blood obtained in nations whose ruminant serum exports to the United States have been authorised by the United States Department of Agriculture (USDA). Australia, Canada, Chile, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, New Zealand, Nicaragua, and Panama are among the nations that are permitted to export foetal bovine serum to the United States.
Vaccines and FBS
With the most recent advancements in science, such as stem cells, cell therapy, novel vaccines, and proteomics, the demand for FBS is increasing.
Because Australia is thought to be a "safer" origin for BSE and cow infections, Australian FBS prices are higher. The first nations outside of the USA where FBS was created were Canada and Australia. North American BSE instances in the 1980s developed into a compelling argument in favour of Australian FBS. It was said that Australia was undoubtedly the safest origin because of its "isolation."
FBS imports are less controlled in the EU than they are in the USA. The US FBS sector rejected a USDA request to adopt the same import regulations for FBS as the EU in 1994. The International Serum Industry Association (ISIA) encourages adherence to the OIE standards and supports attempts to unify import regulations. FBS is still more than twice as expensive in the USA as it is in Europe.
One or more active compounds are the main components in every vaccine. Other than this, water is the primary component of vaccinations. The majority of injectable vaccines comprise 0.5 millilitres, or a few drops, of liquid. The total weight of the remaining ingredients is zero grammes or a few milligrammes at most.
Contrary to food products, vaccine ingredient lists may include items utilised in manufacturing even if they are not present in the final product. There are very trace amounts of additional components (usually a few milligrams). None of the materials needed to make the vaccinations or cultivate the active components may make it into the finished product. If they do, there are simply traces of them.
Ingredients in vaccines can seem strange. However, it's critical to keep in mind that a lot of the ingredients in vaccinations are produced naturally by the body. For instance, many vaccinations contain salts based on sodium and potassium, which are vital for life (see the section on "Acidity regulators"). Although formaldehyde is typically thought of as a chemical produced by humans, it is also naturally present in the circulation in minute amounts.
There is no evidence to suggest that any of the chemicals in vaccines, which are all present in extremely minute amounts, are harmful. The rare individuals who may be extremely allergic to a vaccine ingredient, even if it is present in minuscule amounts, are the exception to this rule (for example, egg proteins or antibiotics used in vaccine manufacture). Although some of the components in vaccines may be dangerous, the majority of them are present in vaccines in concentrations that are entirely acceptable for human bodies. Even common salt (sodium chloride), which is necessary for the body to operate normally, is dangerous in big doses.
Active components are the components of the vaccination (also known as "antigens") generated from viruses or bacteria. So that it can produce antibodies to attack the disease, they put the immune system to work. Only a few micrograms (millionths of a gramme) of active chemicals are present in each vaccine. One paracetamol pill includes 500 milligrammes of the medication to give you a sense of how little these amounts are. The amount of the active component in this is thousands of times greater than what is present in the majority of vaccines. A single teaspoon of the active ingredient might be used to make hundreds of thousands of unique vaccinations.
Is Heat inactivated fetal bovine serum necessary or recommended?
The complement system was once inactivated for immunoassays by heating serum to 56°C for 30 minutes. Other unidentified inhibitors of cell growth in culture have also been reported to be rendered inactive by heat activation. However, the procedure is pricy and labour-intensive. As too high of a temperature or for too long of a period may damage some growth factors, the procedure must be strictly followed.
Due to laboratory history or the convenience of keeping only one type of serum, heat inactivation of serum is occasionally utilised.
To inactivate the complement protein present in newborn calf serum, Coriell previously employed only heat-inactivated serum for their cell cultures. Since switching to foetal bovine serum, we have discovered that most cell lines do not require heat-inactivated fetal bovine serum. The majority of lymphoblast and fibroblast lines do not appear to be affected by whether the serum is heat-inactivated or not, yet occasionally we do identify a differentiated cell line that grows better in heat-inactivated fetal bovine serum. The original cell line's serum can be found in the online Coriell catalogues (either heat-inactivated or "not inactivated"). The culture conditions are modified to mirror current practice when we create an expansion slot of the cell line ("not inactivated") for most cell lines.
So to conclude, you can utilise heat-inactivated fetal bovine serum without any issues if your lab typically keeps it on hand. In actuality, the heat-inactivated serum is used in a large number of labs that use Coriell cell lines. And FBS has proven to be the most effective supplement.
- Libny Auguste