Table 1.
Product, manufacturer | Purification method | Viral Inactivation method | VWF:RCo/Ag (ratio)* | VWF:RCo/FVIII (ratio)* |
---|---|---|---|---|
Alphanate, Grifols | Heparin ligand CT | S/D + dry heat (80°C, 72 h) | 0.9 | 1.2 |
Factor 8Y, Bio Products Laboratory | Heparin/glycine precipitation | Dry heat (80°C, 72 h) | 0.6 | 1.8 |
Fanhdi, Grifols | Heparin ligand CT | S/D + dry heat (80°C, 72 h) | 0.8 | 1.2 |
Haemate P, CSL Behring | Multiple precipitation | Pasteurization (60°C, 10 h) | 0.8 | 2.4 |
Immunate, Baxalta | Ion exchange CT | S/D + vapor heat (60°C, 10 h) | 0.6 | 0.8 |
Talate, Takeda | Ion exchange CT | S/D + vapor heat (60°C, 10 h) | 0.5 | 1.1 |
Voncento/Biostate, CSL Behring | Multiple precipitation + albumin ligand CT | S/D + dry heat (80°C, 72 h) | 0.8 | 2.4 |
Vonvendi, Takeda | Recombinant VWF, IA purification | NF | – | Negligible FVIII |
Wilate, Octapharma | Ion exchange + size exclusion CT | S/D + dry heat (100°C, 72 h) | 0.9–1.0 | 1.0 |
Wilfactin, LFB | Ion exchange + affinity CT | S/D + NF + dry heat (80°C, 72 h) | 0.7 | 60 |
Ag, antigen; CT, chromatography; FVIII, factor VIII; IA, immune-affinity; NF, nanofiltration; RCo, ristocetin cofactor; S/D, solvent/detergent; VWF, von Willebrand factor.
Data derived from the WFH Online Registry of Clotting Factor Concentrates, 2018.