Table 2.
Recombinant coagulation factor IX products approved for Hemophilia B treatment.
| Product | Company | Generation | Cell line | Main characteristics | Approval year |
|---|---|---|---|---|---|
| BeneFIX® | Pfizer | 3 | CHO | Molecule with Ala-148 polymorphism | 1997, FDA |
| Non mAb-based chromatography | |||||
| Sucrose as stabilizer | |||||
| t1/2=18.8h | |||||
| Rixubis® | Baxter/Baxalta | 3 | CHO | Molecule with Ala-148 polymorphism | 2013, FDA |
| Non mAb-based chromatography | |||||
| Mannitol/Sucrose as stabilizer | |||||
| t1/2=25.4-26.7h | |||||
| Alprolix® | Biogen Idec | 4 | HEK-293 | rFIX-IgG1 Fc fusion protein | 2014, FDA |
| Protein A affinity chromatography | |||||
| Mannitol/Sucrose as stabilizer | |||||
| t1/2=82.1h | |||||
| Ixinity® | Emergent Biosolutions | 3 | CHO | Molecule with Thr-148 polymorphism | 2015, FDA |
| Mannitol/Trehalose as stabilizer | |||||
| t1/2=24h | |||||
| Idelvion® | CSL Behring | 3 | CHO | rFIX-Albumin fusion protein | |
| Mannitol/Sucrose as stabilizer | 2016, FDA | ||||
| t1/2=92-94,8h |
Abbreviations: CHO – Chinese Hamster Ovary cells; Hek-293; Human Embryonic Kidney cells.