C018: Advate / Kogenate Biosimilar Stable Cell Line
The yield of Advate / Kogenate Biosimilar from the CHO stable cell line was above 60 IU/ml in a 50 liter manufacturing.
BP001601-C272: Recombinant Human Apoptosis-Inducing Factor 1 Mitochondrial (AIFM1) Protein
Source: E. coli-derived.
Purity: > 95% by SEC-HPLC and reducing SDS-PAGE.
Endotoxin: < 0.1 ng/ug (1 IEU/ug).BP000691-ENZ-349: Recombinant Human Activated protein C cofactor (APC)
Source: Chinese Hamster Ovary Cells (CHO)-derived.
Purity: > 99%, by RP-HPLC and SDS-PAGE.C019: BeneFIX Biosimilar Stable Cell Line (CHO)
The yield of BeneFIX biosimilar from the CHO stable cell line was above 20 IU/mL in a 15 liter manufacturing.
C019P: BeneFIX Biosimilar, Recombinant Factor IX
The yield of BeneFIX biosimilar from the CHO stable cell line was above 20 IU/mL in a 15 liter manufacturing.
C018: Advate / Kogenate Biosimilar Stable Cell Line
The yield of Advate / Kogenate Biosimilar from the CHO stable cell line was above 60 IU/ml in a 50 liter manufacturing.
BP000469-PRO-353: Human Factor IX Protein
Source: Human Plasma-derived.
The activity per mg was tested and found to be 195 Units per mg.
Purity: > 95% by SDS-PAGE.BP000036-GD10: Recombinant Human FVII Protein
Source: HEK 293 cell derived.
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.BP000036-GD11: Recombinant Human FVIIa Protein
Source: 293 cell derived.
The potency per mg of recombinant human FVIIa protein was tested and found to be 50,000 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.BP001902-PRO-331: Recombinant Human Coagulation Factor VIIa (FVIIa) Protein
Source: BHK cells-derived.
The potency per mg of recombinant human FVIIa protein was tested and found to be 50,000 Units/mg.
Purity: > 98.0% as determined by (a) Analysis by RP-HPLC; (b) Analysis by SDS-PAGE.