Table 2.

Type of products currently used for replacement therapy in hemophilia A and B

Type of product	Comments
Hemophilia A
Intermediate-purity plasma-derived FVIII concentrates	Purification from cryoprecipitate through multiple precipitation; single-step viral inactivation
High-purity plasma-derived FVIII concentrates	Purification through ion-exchange, heparin ligand or monoclonal antibody chromatography; single- or double-step viral inactivation
Full-length recombinant FVIII concentrates	– From BHK-cultured cells in the presence of HSA, stabilized in sucrose; SD viral inactivation – From CHO-cultured cells without HSA, stabilized in trehalose; SD viral inactivation
B-domain deleted recombinant FVIII concentrate	From CHO-cultured cells without HSA and animal protein; SD viral inactivation and nanofiltration
Hemophilia B
High-purity plasma-derived FIX concentrates	Purification through immunoaffinity or ion exchange plus carbohydrate- or heparin-ligand chromatography; single- or double-step viral inactivation
Recombinant FIX concentrate	From CHO-cultured cells, without HSA; nanofiltration
Hemophilia with inhibitors (by-passing agents)
APCC	Plasma-derived; batch-controlled surface activation of prothrombin complex; vapour heat viral inactivation
rFVIIa	From BHK cultured cell; FVII autoactivation during chromatographic purification; SD viral inactivation

Abbreviations: BHK, baby hamster kidney; CHO, chinese hamster ovary; HSA, human serum albumin; SD, solvent/detergent; FVIII, factor VIII; FIX, factor IX; APCC, activated prothrombin complex concentrates; rFVIIa, recombinant activated factor VII.