Coagulation factor replacement therapy products are either plasma-based or recombinant—made without human blood, plasma or proteins. Compared to plasma-based treatments, recombinant manufacturing minimizes the risk of blood-borne pathogens.1
Our manufacturing process
Novo Nordisk manufactures only recombinant factor products, which are produced in cell lines engineered to include the gene for human clotting factors. These cell lines are considered to be free of viruses.2
Recombinant factor products undergo multiple steps to ensure safety and purity2
Cell Bank: Cells are created that produce clotting factor identical or similar to the one that occurs naturally in the human body
Production: The clotting factor is made by cells grown under careful lab conditions
Purification: A cleansing process removes any remaining impurities
Preparation: The factor is freeze-dried and prepared for long-term storage and use as needed
Quality control: A final inspection ensures a high quality product
The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) issues expert recommendations, statements, and advisories on treatment and care of bleeding disorders.
Guidelines for bleeding disorders
Access MASAC recommendations to determine when recombinant products are recommended for the management of bleeding disorders.
- National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #263. New York, NY: National Hemophilia Foundation; 2020.
- Pipe SW. Recombinant clotting factors. Thromb Haemost. 2008;99(5):840-850.