The Factor VIII is isolated from the other plasma proteins 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. An ion exchange process is used to further the purification. The monoclonal antibody process results in a very pure Factor VIII product with no other plasma proteins.
M contains trace amounts of mouse protein.
M is made from human blood, collected from paid apharesis donors. Therefore the presence of infectious agents, including unknown diseases, cannot be excluded. However, studies have shown, over more than 10 years of usage, no reported cases of HIV, hepatitis B or hepatitis C transmission. Their plasma is not used if any screening test is positive. M goes through 3 independent manufacturing steps which remove viruses.