BP000037-GD12: Recombinant Human FVIII Protein
Source: 293 cell-derived
The potency per mg of recombinant human FVIII protein was tested and found to be 11,000 Units/mg.
Endotoxin Level: <1.0 EU per 1 ug of the protein by the LAL method.
Purity > 95%, by SDS-PAGE under reducing conditions and visualized by silver stain.BP000470-PRO-317: Human Coagulation Factor-VIII (FVIII) Protein
Source: Human Plasma-derived.
The potency per mg of Human Coagulation Factor-VIII was tested and found to be 150 Units/mg.BP000470-PRO-318: Recombinant Human Coagulation Factor-VIII (FVIII) Protein
Source: CHO cells-derived.
The specific activity of recombinant human FVIII Protein was found to be 7428 IU/mg.
Purity: > 97.0% as determined by SDS-PAGE.C017: ReFacto Biosimilar Stable Cell Line (CHO)
The yield of ReFacto biosimilar from the CHO stable cell line was above 60 IU/mL in a 50 liter manufacturing.