Traceability is important because it provides a chain of identity of the product from the country and slaughterhouse of origin to the processing, packaging and labeling facilities ready for sale and final distribution. As you can verify, traceability ensures that the product you purchase was made respecting regulations at each level. This unbroken chain of information means complete transparency and entire compliance for all levels of research and settings.
SeraPrime works directly with manufacturers who have implemented supply chain controls from harvesting the raw material to filling sterile bottles.
These rigorous traceability controls guarantees complete product traceability, from raw material until the finished product. This enables SeraPrime to determine batch lineage and global traceability.
(*) Art to Science, Vol.19, No.2, “Serum Stability at Refrigerated Temperatures (2-8°C).
Serum is thawed at 2-8°C to prevent degradation; alternatively, it may be thawed at room temperature with periodic agitation to resuspend the contents. Thawed serum should be mixed thoroughly before being added to cell culture medium.
Temperatures above 37°C can compromise serum performance by accelerating the degradation of critical serum factors and should be avoided in the lab.
Turbidity and flocculent material may be present after thawing or after prolonged freezing and/or refrigeration. Our experience indicates these modifications do not affect the biological performance of the serum.
- Some of the precipitates are due to fibrin:
Our collection procedures and rapid freezing may leave some fibrinogen in the serum. Fibrinogen is the soluble precursor of the clot-forming protein, fibrin. The fibrin may appear after thawing or heat inactivation. Fibrin does not alter the capacity of the serum to promote cell growth. It is recommended to use the serum without treatment (filtration or centrifugation).
- Some of the precipitates are due to Calcium Phosphate:
Serum that is incubated at 37°C for extended periods will become cloudy and deposits may appear. They are composed of calcium and phosphorous. To the best of our knowledge, this does not alter the performance of the serum in cell cultures.
For most cell culture applications, heat inactivation of serum is not recommended. Heat inactivation degrades complement proteins that may interfere with immunological assays. Heating serum for prolonged periods of time can reduce or destroy growth factors, as well as increase the formation of deposits which are commonly mistaken for microbial contamination.
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 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.
Endotoxin is lipopolysaccharide found in gram negative bacteria’s outer cell membrane. Endotoxin is measured in “Endotoxin Units” per mL (EU/mL).
Suggested industry standard is <10 EU/mL, some manufacturers will advertise lowest levels are “better” for cell growth and justify a higher serum cost. If your application does not have endotoxin requirements than the use of a “Standard Grade” with slightly elevated levels will offer savings and same quality/performance.
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.
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. 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.
The serum is tested for the viruses (BVD, IBR, P13) by using a cell culture method, so that live viruses, if present, are detected in the serum.
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 breaks some proteins and decolorate the product by reducing hemoglobin 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.
SeraPrime suggests you test your cell lines with gamma irradiated serum in order to define the potential impact of the treatment on your applications.