The Factor VIII is isolated from the culture medium through the use of a mouse antibody which attaches itself to the Factor VIII molecules at a certain step in the manufacturing process. The unattached material is then washed away. Another substance is added to separate the Factor VIII from the mouse antibody. As an additional purification step, Recombinate tm goes through a 2-stage ion exchange process. The recombinant antihemophilic factor in Recombinate tm has the same biological effects as human antihemophilic factor which is derived from plasma Recombinate tm contains trace amounts of mouse, hamster and bovine protein.
Human albumin is added to the final product as a stabilizer.
In addition, human albumin is added to the final product. Human albumin has never been known to transmit viruses or other pathogens. Because of the presence of these human proteins, it cannot be said that Recombinate tm is free of human blood-borne pathogens. However, most experts agree that recombinant products offer a margin of safety in comparison to plasma-derived products. At present, there is no test to screen out CJD-associated donations, nor do current viral inactivation methods eliminate the abnormal prion protein.