Coagulation factor concentrates for use in recessively inherited coagulation disorders
Coagulation factor (brand) . | Manufacturer . | Fractionation . | Viral inactivation . | Comments . |
|---|---|---|---|---|
| Fibrinogen (Haemocomplettan HS) | ZLB Behring, Marburg, Germany | Multiple precipitation | Pasteurization at 60°C, 20 h | Albumin added |
| Fibrinogen (Clottagen) | LFB, Les Ulis, France | Cryoprecipitation, adsorption on aluminum hydroxide gel, anion exchange chromatography | TNBP/polysorbate 80 | — |
| Fibrinogen | SNBTS, Edinburgh, Scotland | Multiple precipitation, ion exchange chromatography | TNBP/polysorbate 80; dry heat, 80°C, 72 h | — |
| Fibrinogen (Fibroraas) | RAAS, Shanghai, China | Multiple fractionation | TNBP/polysorbate 80 | — |
| Factor VII | Bio Products Laboratory, Elstree, United Kingdom | Ion exchange chromatography | Dry heat, 80°C, 72 h | — |
| Factor VII (Facteur VII) | LFB | DEAE adsorption, anion exchange chromatography | TNBP/polysorbate 80 | — |
| Factor VII (Provertin) | Baxter, Vienna, Austria | Ion exchange chromatography | Vapor heat, 60°C, 10 h, at 190 mbar + 80°C, 1 h, at 37/5 mbar | — |
| Recombinant activated factor VII (NovoSeven) | NovoNordisk, Bagsvaerd, Denmark | Recombinant | Yes, not disclosed | Primarily licensed for hemostasis in presence of inhibitors |
| Factor XI | Bio Products Laboratory | Affinity heparin Sepharose chromatography | Dry heat, 80°C, 72 h | Heparin and antithrombin added |
| Factor XI (Hemoleven) | LFB | Dialysis, cation exchange chromatography | TNBP/polysorbate, 15 nm nanofiltration | Heparin, antithrombin, and C-1 esterase inhibitor added |
| Factor XIII (Fibrogammin HS) | ZLB Behring | Multiple precipitation | Pasteurization at 60°C, 10 h | Albumin added |
Coagulation factor (brand) . | Manufacturer . | Fractionation . | Viral inactivation . | Comments . |
|---|---|---|---|---|
| Fibrinogen (Haemocomplettan HS) | ZLB Behring, Marburg, Germany | Multiple precipitation | Pasteurization at 60°C, 20 h | Albumin added |
| Fibrinogen (Clottagen) | LFB, Les Ulis, France | Cryoprecipitation, adsorption on aluminum hydroxide gel, anion exchange chromatography | TNBP/polysorbate 80 | — |
| Fibrinogen | SNBTS, Edinburgh, Scotland | Multiple precipitation, ion exchange chromatography | TNBP/polysorbate 80; dry heat, 80°C, 72 h | — |
| Fibrinogen (Fibroraas) | RAAS, Shanghai, China | Multiple fractionation | TNBP/polysorbate 80 | — |
| Factor VII | Bio Products Laboratory, Elstree, United Kingdom | Ion exchange chromatography | Dry heat, 80°C, 72 h | — |
| Factor VII (Facteur VII) | LFB | DEAE adsorption, anion exchange chromatography | TNBP/polysorbate 80 | — |
| Factor VII (Provertin) | Baxter, Vienna, Austria | Ion exchange chromatography | Vapor heat, 60°C, 10 h, at 190 mbar + 80°C, 1 h, at 37/5 mbar | — |
| Recombinant activated factor VII (NovoSeven) | NovoNordisk, Bagsvaerd, Denmark | Recombinant | Yes, not disclosed | Primarily licensed for hemostasis in presence of inhibitors |
| Factor XI | Bio Products Laboratory | Affinity heparin Sepharose chromatography | Dry heat, 80°C, 72 h | Heparin and antithrombin added |
| Factor XI (Hemoleven) | LFB | Dialysis, cation exchange chromatography | TNBP/polysorbate, 15 nm nanofiltration | Heparin, antithrombin, and C-1 esterase inhibitor added |
| Factor XIII (Fibrogammin HS) | ZLB Behring | Multiple precipitation | Pasteurization at 60°C, 10 h | Albumin added |
Information on these products was obtained from the January 2004 update of Registry of Clotting Factor Concentrates (http://www.wfh.org/showdoc.asp?Rubrique=31&Document=121). DEAE indicates diethylaminoethyl; and TNBP, tri-n-butyl phosphate.