Major differences between pdFVIII and rFVIII products
| . | pdFVIII . | HEK293-derived rFVIII . | Second-generation BHK-derived rFVIII . | Third-generation CHO-derived rFVIII . | References . |
|---|---|---|---|---|---|
| Galα1-3Gal | Not present | Not present | Found in 3% (molar ratio) of N-linked glycans | Below limit of detection | 12, 13 |
| Neu5Gc | Not present | Not present | Below limit of detection | Present in 0.5% (molar ratio) of N-linked glycans | 12, 13 |
| ABO antigens | Present | Not present | Not present | Not present | 12, 13 |
| % nonsulfated Tyr1680 | Undetectable | Undetectable | 1.55% ± 0.07% | 6.65% ± 1.91% | 12 |
| Culture conditions | NA | No proteins of animal or human origin | Contains human plasma proteins | Co-expressed with VWF without any animal or human plasma protein additives | 14 (product monograph) |
| Additional proteins | VWF, fibronectin, fibrinogen, IgM, IgG, albumin, inter-α inhibitor, TGF-β, and others | Not reported | Not reported | Not reported | 15, 16 |
| FVIII sequence differences | ≥56 nonsynonymous variants in 2353 healthy individuals | Not reported (B-domain deleted) | Aspartic acid at amino acid 1241 | Glutamic acid at amino acid 1241 | 10, 11 |
| . | pdFVIII . | HEK293-derived rFVIII . | Second-generation BHK-derived rFVIII . | Third-generation CHO-derived rFVIII . | References . |
|---|---|---|---|---|---|
| Galα1-3Gal | Not present | Not present | Found in 3% (molar ratio) of N-linked glycans | Below limit of detection | 12, 13 |
| Neu5Gc | Not present | Not present | Below limit of detection | Present in 0.5% (molar ratio) of N-linked glycans | 12, 13 |
| ABO antigens | Present | Not present | Not present | Not present | 12, 13 |
| % nonsulfated Tyr1680 | Undetectable | Undetectable | 1.55% ± 0.07% | 6.65% ± 1.91% | 12 |
| Culture conditions | NA | No proteins of animal or human origin | Contains human plasma proteins | Co-expressed with VWF without any animal or human plasma protein additives | 14 (product monograph) |
| Additional proteins | VWF, fibronectin, fibrinogen, IgM, IgG, albumin, inter-α inhibitor, TGF-β, and others | Not reported | Not reported | Not reported | 15, 16 |
| FVIII sequence differences | ≥56 nonsynonymous variants in 2353 healthy individuals | Not reported (B-domain deleted) | Aspartic acid at amino acid 1241 | Glutamic acid at amino acid 1241 | 10, 11 |
IgM, immunoglobulin M; NA, not applicable.