Fetal Bovine Serum - Optima, Gamma Irradiated, Heat Inactivated

Fetal Bovine Serum - Optima, Gamma Irradiated, Heat Inactivated Summary

Key Benefits

• Ideal for use in virus, vaccine, and biomanufacturing
• Cobalt-60 source gamma irradiation, 25 – 40 kGy
• US-origin and certified
• High lot-to-lot consistency, low endotoxin, and low hemoglobin levels
• Extensive biochemical and virus testing
• Manufactured in our ISO 9001:2015 certified facility

Why Use Gamma Irradiated Fetal Bovine Serum?

When using fetal bovine serum to supplement into cell culture medium there is low risk for introducing contaminating agents, such as adventitious viruses or mycoplasma. Treating serum with gamma irradiation is a common method to reduce pathogen burden while maintaining the performance integrity of fetal bovine serum. Gamma irradiation has been reported to result in a 6-8 log reduction in contaminating agents in serum. Gamma irradiated fetal bovine serum is often required in biomanufacturing workflows to reduce the risk of contamination for virus or vaccine production.

FBS – Optima, Gamma Irradiated is exposed to a Cobalt-60 source of irradiation, delivered at a dose of 25.0 – 40.0 kGy, which has been shown to remove up to 6 logs of many contaminating pathogens. Irradiation is performed following production and bottling of FBS – Optima, R&D Systems US-origin and USDA-APHIS certified fetal bovine serum. Optima FBS is manufactured in ISO 9001:2015 certified facility.

Heat Inactivation - Serum is inactivated by raising the temperature to 56 °C for 30 minutes under controlled conditions. The objective of heat inactivation is to destroy complement activity in the serum without affecting the growth-promoting characteristics of the product. Removal of complement activity from the serum is not required for most cell cultures, but may be necessary for cultures that are sensitive to the complement activity. Since heat inactivation of the serum may, to some extent, decrease the growth performance properties of the serum, this procedure should only be performed if actually required for optimal cell growth. Researchers should evaluate the applicability of heat inactivation in regards to their own application. If heat inactivation is required, the process should be carefully controlled to avoid increased formation of crystalline and flocculent precipitates, gelling of serum proteins and excessive loss of growth performance. Significant damage to serum can occur when it is subjected to higher than required temperatures or heated over extended lengths of time.



Protocol for Heat Inactivation of Serum Products.
Protocol for Fetal Bovine Serum Storage, Thawing, and Freezing.

Collection, Processing, and Testing of R&D Systems FBS

Collection and Processing - R&D Systems FBS is manufactured under a process that meets USDA requirements for animal products and ensures the product is traceable back to the date and location of collection. Our FBS manufacturing adheres to closed-system collection, processing in positive pressure, HEPA-filtered clean rooms, and triple 0.1 um filtration to remove contaminants. Strict control of the process from collection through processing enables us to provide a stable, consistent performing, and traceable supply of quality serum throughout global fluctuations in serum availability and regulatory requirements.

Virus Testing - Fetal Bovine Serum – Optima undergoes testing for adventitious viruses, such as: Bovine Viral Diarrhea Virus (BVDV), Infectious Bovine Rhinotracheitis Virus (IBRV), Parainfluenza-3 Virus (PI-3V), Bluetongue Virus (BTV), Bovine Respiratory Syncytial Virus (BRSV), Bovine Parvovirus (BPV), Bovine Adenovirus, Type 3 (BAV-3), Bovine Adenovirus, Type 5 (BAV-5), Reo virus, and Rabies virus.

Biochemical Testing - R&D Systems FBS undergo biochemical profiling including total protein, albumin, globulin, IgG, total bilirubin, glucose, iron, cholesterol, triglycerides, sodium and potassium. View the product insert for a complete list of biochemical profiling components, which may vary between grades.

Chemical Analysis - Each lot of FBS is tested for osmolality, pH, hemoglobin, endotoxin (LAL method) and microbiological contamination (using methods recommended by the U.S. Pharmacopeia).

Specifications

Limitations

For research use only. Not for diagnostic use.

Product Datasheets