Table 2.
VWF/FVIII concentrates licensed for the treatment of von Willebrand disease in Europe and North America
Product | Manufacturer | Purification | Viral inactivation | VWF:RCo/Ag# (Ratio) | VWF: RCo/FVIII# (Ratio) |
---|---|---|---|---|---|
Alphanate | Grifols | Heparin ligand chromatography | S/D + dry heat (80°C, 72 h) | 0.47 ± 0.1 | 0.91 ± 0.2 |
Factor 8Y | BioProducts | Heparin/glycine precipitation | Dry heat (80°C, 72 h) | 0.29 | 0.81 |
Fanhdi | Laboratory Grifols | Heparin ligand chromatography | S/D + dry heat (80°C, 72 h) | 0.47 ± 0.1 | 1.04 ± 0.1 |
Haemate P/ | |||||
Humate | CSL Behring | Multiple precipitation | Pasteurization (60°C, 10 h) | 0.59 ± 0.1 | 2.45 ± 0.3 |
Talate | Shire | Ion exchange chromatography | S/D + vapor heat (60°C, 10 h) | 0.47 | 1.1 |
Wilate | Octapharma | Ion exchange + size exclusion | S/D + dry heat (100°C, 2 h) | - | 0.9 |
Wilfactin | LFB | Chromatography Ion Exchange + affinity | S/D, 35 nm filtration, dry Heat (80°C, 72 h) | ≈0.95 | ≈50 |
VonVendi | Shire | Chinese Hamster Ovary (CHO) cell line co-expressing the VWF and FVIII genes, in absence of any animal or other human plasma proteins; purified by immune-affinity chromatography | - | - | - |