A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Refacto Online, Description, Chemistry, Ingredients - Antihemophilic Factor
Refacto Online, Description, Chemistry, Ingredients - Antihemophilic Factor
DESCRIPTION
ReFacto® Antihemophilic Factor (Recombinant) is a purified protein produced
by recombinant DNA technology for use in therapy of factor VIII deficiency.
ReFacto is a glycoprotein with an approximate molecular mass of 170 kDa consisting
of 1438 amino acids. It has an amino acid sequence that is comparable to the
90 + 80 kDa form of factor VIII, and post-translational modifications that are
similar to those of the plasma-derived molecule. ReFacto has in vitro functional
characteristics comparable to those of endogenous factor VIII.
ReFacto is produced by a genetically engineered Chinese hamster ovary (CHO)
cell line. The CHO cell line secretes B-domain deleted recombinant factor VIII
into a defined cell culture medium that contains human serum albumin and recombinant
insulin, but does not contain any proteins derived from animal sources. The
protein is purified by a chromatography purification process that yields a high-purity,
active product. The potency expressed in international units (IU) is determined
using the European Pharmacopoeial chromogenic assay against the WHO standard.
The specific activity of ReFacto is 11,200-15,500 IU per milligram of protein.
ReFacto is not purified from human blood and contains no preservatives or added
human components in the final formulation.
ReFacto is formulated as a sterile, nonpyrogenic, lyophilized powder preparation
for intravenous (IV) injection. It is available in single-use vials containing
the labeled amount of factor VIII activity (IU). Each vial contains nominally
250, 500, or 1000 IU of ReFacto per vial. The formulated product is a clear
colorless solution upon reconstitution and contains sodium chloride, sucrose,
L-histidine, calcium chloride, and polysorbate 80.
top
