Fetal Bovine Serum - Premium Select, Gamma Irradiated

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 – Premium Select, 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 – Premium Select, R&D Systems highest quality fetal bovine serum. Lots are manufactured from USA origin or USDA-approved origin material following stringent manufacturing and quality control procedures. All lots of FBS - Premium Select are manufactured in our ISO 9001:2015 certified facility.

Gamma Irradiated fetal bovine serum should be stored and handled correctly to assure long-term stability and to preserve growth performance consistency throughout its shelf-life. In addition, heat inactivation of serum is frequently desired to inactivate complement within the serum. Below are protocol links for serum storage/handling and heat inactivation.
Protocol for Heat Inactivation of Serum Products
Protocol for Fetal Bovine Serum Storage, Thawing, and Freezing.

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 – Premium Select 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).