The recombinant factor VIII production cells are created by first isolating the active part of human gene for factor FVIII. This part is then inserted into a production cell. The recombinant production cells are then placed in specially made containers called bioreactors where the cells grow, multiply and produce the FVIII protein in high quantities under controlled conditions.
The Nuwiq® production cell line is a recombinant human cell line and thus the produced protein is similar to the FVIII naturally occurring in man.
The purification process of Nuwiq® includes five chromatography purification steps and two dedicated steps for viral inactivation and removal: solvent detergent process for inactivation of enveloped viruses and nanofiltration for removal of viruses. After purification, recombinant FVIII is formulated and freeze-dried as Nuwiq®.
No animal or human-derived materials are added during the manufacturing process or to the final product, making it naturally free from the risk of transmission of blood-borne pathogens.
