Each lot is screened by growing human mesenchymal stem cells (hMSC) over a minimum of three subculture generations with 10 percent serum. Human MSC are then observed for evidence of nutritional deficiency, cytotoxicity or morphological aberrations. The serum is tested in parallel with a control lot which has been demonstrated to support the growth of hMSC.

HyClone™ Characterized Fetal Bovine Serum (FBS) is produced using true pool processing, which minimizes bottle-to-bottle variability. This FBS product is filtered through three sequential 100 nm (0.1 µm) pore size-rated filters. Each lot of FBS is subjected to virus panel testing according to 9 CFR 113.53. HyClone™ Characterized FBS is assayed for many components, including gamma globulin, glucose, and IgG.

Additional treatments available including heat-inactivation and irradiation. Additional testing, including EMA-conforming testing, is also available.