F8 Human
Human Plasma.
Description
Human Factor VIII produced from Human Plasma contains 2332 amino acids and having a molecular mass of 330kDa. Factor-VIII is effective in the correction and prevention of severe bleeding episodes attributed to Factor VIII deficiency.
The Factor-VIII is purified by proprietary chromatographic techniques.
Product Specs
Human Factor VIII, derived from human plasma, consists of 2332 amino acids and possesses a molecular mass of 330kDa. This factor plays a crucial role in correcting and preventing bleeding episodes associated with Factor VIII deficiency.
Purification of Factor-VIII is achieved through proprietary chromatographic techniques.
The lyophilized protein, at a concentration of 200IU/ml, is prepared from a sterile solution containing 1.5% Glycine, 160mM Calcium chloride, 25mM NaCitrate, and 25mM NaCl.
Reconstitution of the lyophilized Factor-VIII is recommended using sterile 18MΩ-cm H2O to achieve a concentration of 200IU/ml. This solution can be further diluted with other aqueous solutions as needed.
Ensure the vial is at room temperature before reconstitution to prevent potential precipitation.
While lyophilized Factor-VIII remains stable at room temperature for up to one week, it is recommended to store it desiccated between 2-8°C. Following reconstitution, Factor-VIII should be stored at 4°C.
The determined potency is 10 Units/mg.
Plasma is sourced from donors who have been vaccinated against Hepatitis B.
Every unit of plasma undergoes rigorous testing for HBsAg, Anti-HIV-1/2 plus O, and Anti-HCV using FDA-approved imported kits.
Human Plasma.
Product Science Overview
Factor VIII is a large glycoprotein that circulates in the plasma in an inactive form, bound to von Willebrand factor (vWF). Upon vascular injury, Factor VIII is activated and separates from vWF. The active form, known as Factor VIIIa, acts as a cofactor for Factor IXa. In the presence of calcium ions (Ca²⁺) and phospholipids, this complex converts Factor X to its activated form, Factor Xa .
The F8 gene produces two alternatively spliced transcripts. Transcript variant 1 encodes a large glycoprotein, isoform a, which circulates in plasma and associates with vWF in a noncovalent complex. Transcript variant 2 encodes a smaller protein, isoform b, which consists primarily of the phospholipid-binding domain essential for coagulant activity .
Human Coagulation Factor VIII is produced in the liver’s sinusoidal cells and endothelial cells outside the liver. It is prepared from human plasma that complies with specific monographs on plasma fractionation . Recombinant DNA technology has also enabled the production of synthetic Factor VIII, which is used in the treatment of Hemophilia A to replace the deficient or defective protein .
