NUWIQ is produced using human cells instead of hamster cells
- Expresses only human post-translational modifications to more closely resemble the Factor VIII protein the body produces naturally3
Why human cell line?
- Human cells can more closely replicate human glycosylation patterns
- Expresses only human post-translational modifications to more closely resemble the Factor VIII protein the body produces naturally
- Non-human glycosylation patterns may trigger an immune response
- Although development of inhibitors may occur, NUWIQ may reduce the potential to trigger an immune response and form inhibitors
Glycosylation is the process of adding carbohydrates (sugars) to proteins
Recombinant Factor VIII (rFVIII) protein expression in hamster cells results in carbohydrate structures such as Gal-α1-3-Gal and Neu5Gc. Factor VIII products produced in hamster cells have been associated with the development of inhibitors.
BHK = Baby hamster kidney; CHO = Chinese hamster ovary;
HEK = Human embryonic kidney.
NUWIQ has been shown to have high binding to von Willebrand factor (VWF)1,3
- VWF is a clotting protein that’s produced by the body
- VWF helps minimize unprotected Factor VIII, which may reduce the potential for the development of inhibitors*
VWF binding prevents Factor VIII from being rapidly cleared from circulation3
- In clinical studies in patients with severe Hemophilia A, NUWIQ showed7:
- A 17.1 hour mean Factor VIII half-life in adults and adolescents
*In clinical studies with 135 PTPs (74 adults, 3 adolescents, and 58 children), non-neutralizing antibodies without any inhibitor activity were reported in 4 patients (3%). The most frequently occurring adverse reactions (>0.5%) in clinical trials were paresthesia, headache, injection site inflammation, injection site pain, non-neutralizing anti-Factor VIII antibody formation, back pain, vertigo and dry mouth. Development of FVIII neutralizing antibodies (inhibitors) may occur.
NUWIQ is a B-domain-deleted recombinant human Factor VIII (FVIII) without chemical modification or fusion with any other protein1–6
Two dedicated viral clearance steps are incorporated into the NUWIQ manufacturing process2,6,7:
- Solvent/detergent (S/D) treatment for viral inactivation
- 20 nm nanofiltration for virus removal