Key steps in the manufacturing are ion exchange chromatography and size exclusion chromatography. The Factor VIII is isolated from the culture medium through the use of a monoclonal antibody immunoaffinity chromatography process. This extracts the purified Factor VIII protein. The unattached material is then washed away. Another substance is added to separate the Factor VIII from the mouse antibody.
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. 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. However, there have been no reported cases of CJD transmission through blood transfusions, even though the CJD agent has been around for many years.