Molecular Design Implications
Unlike most of the currently available rFVIII products that are manufactured using a hamster cell line (Chinese Hamster Ovary or Baby Hamster Kidney cells), NUWIQ is produced in a human cell line.1,2
In fact, NUWIQ is the first and only rFVIII produced in a human cell line without chemical modification or protein fusion.1,2
NUWIQ – Produced in a Human Cell Line
- Human cell lines express only human post-translational modifications, like glycosylation and sulfation, to produce a rFVIII protein that closely resembles the FVIII the body produces naturally 3
- Protein expression in hamster cell lines results in glycosylation with non-human epitopes, which are potentially antigenic to humans3
- NUWIQ contains only human glycan epitopes
Glycan Epitopes Found on rFVIII Molecules Produced in Human and Hamster Cell Lines
NUWIQ Contains Only Human Glycan Epitopes
HEK = Human embryonic kidney; CHO = Chinese hamster ovary; BHK = Baby hamster kidney
NUWIQ – Minimizing Unbound FVIII1,3
- FVIII and von Willebrand factor (VWF) are naturally bound together in circulation
- Full sulfation of Tyrosine 1680 (Tyr1680) is vital for VWF-binding affinity and FVIII protection
- NUWIQ is fully sulfated at Tyr1680, with high VWF-binding affinity and less than 1% unbound FVIII
- Minimizing unbound FVIII in circulation may help reduce the risk of FVIII inhibitor development 1
References
- Sandberg H, et al. Thromb Res.2012;130:808-817.
- Casademunt E, et al. Eur J Haematol. 2012;89:165-176.
- Kannicht C, et al. Thromb Res. 2013;131:78-88.