Does Helixate® FS contain albumin?
A. Unlike many other factor VIII concentrates (both plasma-derived and recombinant), Helixate® FS uses sucrose instead of albumin in the final product to stabilize the recombinant factor VIII molecule. However, human albumin is needed to protect and stabilize the recombinant factor VIII protein that is being secreted by the baby hamster kidney cells in the fermentation medium. Most of the albumin is removed during the many purification steps, but a minimal amount of albumin (.007 milligrams/mL) does remain in the product. That is 1000 times less albumin than original Helixate® Antihemophilic Factor (Recombinant). Albumin is not added during the purification or formulation steps.
