Are Biowest products sterile?
Except where notified on product labels, Biowest sera and liquid media are sterile filtered. Sterility is not guaranteed after opening. The use of aseptic manipulation techniques is recommended.
What about bovine viruses?
Some cattle viruses can cross the placenta of the cow and infect the calf fetus, thus contaminating FBS and potentially making it unsuitable for use in cell culture. Some of these cattle viruses have a limited distribution and only exist in certain parts of the world. These are viruses of concern when importing FBS from infected countries - See Table of Diseases of Importation Concern for FBS. Other cattle viruses exist in all countries, and regardless of country of origin, the FBS must be tested or treated to assure freedom from these and other viruses (See USDA 9 CFR 113.53 and EMEA-CPMP-BWP-1793-02). The treatment of choice for most FBS is gamma irradiation at 25-45 kGy to guarantee freedom from viruses.
Foot and mouth disease (FMD): does it matter?
FMD is relevant for regulatory import purposes but not for cell growth. The USA and a few other countries only allow FBS imports from countries free from FMD, WITHOUT vaccination while most other countries also accept FMD-free WITH vaccination. Both types of FMD-free countries are free of FMD outbreaks and circulating FMD viruses, as verified by the OIE and declared equally safe.
What is BSE?
Bovine spongiform encephalopathy (BSE), more commonly known as "mad cow" disease, is a fatal neurodegenerative disease (encephalopathy) in cattle.
What is the risk of BSE in serum products?
According to the OIE (World Animal Health Organization), there is no risk of BSE being transmitted in several products, including: milk, hides and skins, deboned meat, blood and blood by-products, such as fetal bovine serum (OIE Terrestrial Code 11.4 BSE). Most OIE member countries have adopted this position, including the European Union and the United States (USDA).
For some time, BSE was an argument used in favor of certain origins. After the OIE has determined that BSE is not transmitted by blood products, these arguments have become obsolete.
What are the sampling rules for sterility tests on sera?
The sampling for sterility tests of all Biowest products conforms to the European Pharmacopeia requirements.
How are the samples tested for viruses?
Biowest tests the serum for the viruses (BVD, IBR, PI3) by using a cell culture method, so that live viruses, if present, are detected in the serum.
Why is FBS sometimes gamma irradiated?
FBS is sometimes gamma irradiated to eliminate all potential virus risks.
Does gamma irradiation affect FBS performance?
At standard dosage of gamma irradiation, no loss of performance is observed on the first generations of cells. We notice no change on hormones, osmolarity, pH, endotoxins nor electrophoretic profile of the FBS. As ionizing radiations kill viruses, it also break some proteins and decolorate the product by reducing haemoglobin level. Radiations also decrease the serum metabolites (ALP, ALT, AST, LDH) and may slightly affect growth promotion, plating efficiency and cloning efficiency with some cell lines.
Biowest suggests you test your cell lines with gamma irradiated serum in order to define the potential impact of the treatment on your applications.
If viruses seem to modify the results of your work, Biowest also proposes you test FBS Biopharm, our highest quality, certified free of 11 major cattle viruses.
Why not use PCR testing for viruses?
A simple PCR test will detect DNA and RNA from both live and dead viruses. PCR testing must be combined with cell cultures tests to detect live viruses.