Pediatric Clinics of North America - CIPERJ

Table 1
Clotting factor concentrates available in the United States in 2008
Product name (manufacturer)
Human plasma-derived factor VIII concentrates
Humate-P (ZLB Behring, Inc.)
(contains functional VWF protein)
Alphanate SD (Grifols, Inc.)
(contains some functional VWF protein)
Koate-DVI (Bayer, Inc.)
(contains VWF protein)
Viral inactivation procedures
Pasteurization (heating in solution,
60 C, 10 h)
Solvent detergent (TNBP/polysorbate 80)
Affinity chromatography
Dry heat (80 C, 72 h)
Solvent detergent (TNBP/polysorbate 80)
Dry heat (80 C, 72 h)
Purity/specific activity (IU factor VIII activity/mg
total protein) before addition
of stabilizer
Intermediate (1–10 IU/mg)
High (50–100 IU/mg) (O400 IU/mg
after correcting for VWF content)
High (50–100 IU/mg)
Monoclonal antibody-purified factor VIII concentrates (immunoaffinity purified from human plasma, no intact VWF protein)
Monarc-M (Baxter/Immuno, Inc., using Solvent detergent (TNBP/octoxynol 9)
Ultra high (O3000 IU/mg)
recovered plasma from the American
Red Cross)
Immunoaffinity chromatography
Hemofil-M (Baxter/Immuno, Inc.) Solvent detergent (TNBP/octoxynol 9)
Ultra high (O3000 IU/mg)
Immunoaffinity chromatography
Monoclate-P (ZLB Behring, Inc.) Pasteurization (heated in solution, 60 C, 10 h)
Immunoaffinity chromatography
Ultra high (O3000 IU/mg)
Recombinant (genetic-engineered)/first-generation factor VIII concentrates
Recombinate (Baxter/Immuno, Inc.) (human Immunoaffinity, ion exchange
albumin as a stabilizer)
chromatography
Bovine serum albumin used in culture
medium for Chinese hamster ovary cells
Recombinant/second-generation factor VIII concentrates (human albumin-free final formulations)
Kogenate FS (Bayer, Inc.) Helixate FS Immunoaffinity chromatography
(Bayer for ZLB Behring, Inc.) (sucrose as ion exchange
a stabilizer)
Solvent detergent (TNBP/polysorbate 80)
Ultrafiltration
Ultra high (O4000 IU/mg)
Ultra high (O4000 IU/mg)
360 RODRIGUEZ & HOOTS