Table 2.
Characteristics of licensed factor IX concentrates
| Brand name | Company | Source | Fractionation | Viral inactivation | Specific activity (IU/mg) |
|---|---|---|---|---|---|
| Aimafix® | Kedrion | Plasma | Anion exchange, DEAE Sephadex®/Sepharose®, and heparin affinity chromatography | TNBP/polysorbate 80; dry heat, 100°C for 30 minutes; nanofiltration, 35 + 15 nm | >100 |
| AlphaNine® SD | Grifols | Plasma | Dual polysaccharide ligand affinity chromatography | S/D: TNBP/polysorbate 80; nanofiltration | 210 |
| Berinin® P | CSL Behring | Plasma | DEAE Sephadex and heparin affinity chromatography | Pasteurization at 60°C for 10 hours | 146 |
| Betafact® | LFB | Plasma | Ion exchange and affinity chromatography | TNBP/polysorbate 80; nanofiltration, 15 nm | 110 |
| Factor IX Grifols® | Grifols | Plasma | Precipitation and multiple chromatography | S/D; nanofiltration, 15 nm | >150 |
| Haemonine® | Biotest | Plasma | Anion exchange, immunoaffinity, and hydrophobic interaction chromatography | TNBP/polysorbate 80; nanofiltration, 15 nm | >70 |
| Hemo-B-RAAS | Shanghai RAAS | Plasma | Ion exchange and affinity chromatography | S/D; dry heat; nanofiltration | >50 |
| Immunine® | Baxter BioScience | Plasma | Ion exchange and hydrophobic interaction chromatography | Polysorbate 80; vapor heating, 60°C for 10 hours, 190 mbar, then 80°C for 1 hour, 375 mbar | ~100 |
| Mononine® | CSL Behring | Plasma | Immunoaffinity chromatography | Sodium thiocyanate; ultrafiltration | >190 |
| Nanotiv® | Octapharma | Plasma | Ion exchange and affinity chromatography | TNBP/Triton® × 100; nanofiltration | >150 |
| Nonafact® | Sanquin | Plasma | Immunoaffinity and hydrophobic interaction chromatography | TNBP/polysorbate 80; nanofiltration, 15 nm | ≥200 |
| Octanine F® | Octapharma | Plasma | Ion exchange and affinity chromatography | TNBP/polysorbate 80; nanofiltration | >120 |
| Replenine®-VF | Bio products laboratory | Plasma | Metal chelate chromatography | S/D; nanofiltration, 15 nm | 200 |
| TBSF FIX | CSL biotherapies | Plasma | Ion exchange and heparin affinity chromatography | TNBP/polysorbate 80; nanofiltration | >50 |
| BeneFIX® | Pfizer | Recombinant | Anionic chromatography | Nanofiltration | ≥200 |
Abbreviations: DEAE, diethylaminoethanol; S/D, solvent–detergent; TNBP, tri-n-butyl phosphate.