Clotting factor concentrates available in the United States in 2005.
| Product Name (Manufacturer) . | Viral Inactivation Procedure(s) . | Purity/Specific Activity (IU Factor VIII activity/mg total protein) Before Addition of Stabilizer . |
|---|---|---|
| Human Plasma-derived Factor VIII Concentrates | ||
| Humate-P (ZLB Behring, Inc. ) (Contains functional von Willebrand factor protein) | Pasteurization (heating in solution, 60°C, 10 hr) | Intermediate (1–10 IU/mg) |
| Alphanate SD (Grifols, Inc.) (Contains some functional von Willebrand factor protein) | Solvent detergent (TNBP/Polysorbate 80) Affinity chromatography Dry heat (80°C, 72 hr) | High (50–100 IU/mg) (> 400 IU/mg after correcting for VWF content) |
| Koate-DVI (Bayer, Inc.) (Contains von Willebrand factor protein) | Solvent detergent (TNBP/Polysorbate 80) Dry heat (80°C, 72 hr) | High (50–100 IU/mg) |
| Monoclonal Antibody Purified FVIII Concentrates (Immunoaffinity purified from human plasma, no intact von Willebrand factor protein) | ||
| Monarc-M (Baxter/Immuno, Inc., using recovered plasma from the American Red Cross) | Solvent detergent (TNBP/Octoxynol 9) Immunoaffinity chromatography | Ultra high (> 3000 IU/mg) |
| Hemofil-M (Baxter/Immuno, Inc.) | Solvent detergent (TNBP/Octoxynol 9) Immunoaffinity chromatography | Ultra high (> 3000 IU/mg) |
| Monoclate-P (ZLB Behring, Inc.) | Pasteurization (heated in solution, 60°C, 10 hr) Immunoaffinity chromatography | Ultra high (> 3000 IU/mg) |
| Recombinant (Genetic Engineered)/First Generation FVIII Concentrates | ||
| Recombinate (Baxter/Immuno, Inc.) (human albumin as a stabilizer) | Immunoaffinity, Ion exchange chromatography Bovine serum albumin used in culture medium for Chinese hamster ovary cells | Ultra high (> 4000 IU/mg) |
| Recombinant/Second Generation FVIII Concentrates (human albumin-free final formulations) | ||
| Kogenate FS (Bayer, Inc.) Helixate FS (Bayer for ZLB Behring, Inc.) (sucrose as a stabilizer) | Immunoaffinity chromatography Ion exchange Solvent detergent (TNBP/polysorbate 80) Ultrafiltration | Ultra high (> 4000 IU/mg) |
| Refacto (Wyeth, Inc.) B-domain deleted (sucrose as a stabilizer) | Ion exchange Solvent detergent (TNBP/Triton X-100) Nanofiltration | Ultra high (> 11,200–15,500 IU/mg), measured via chromogenic assay technique |
| Recombinant/Third Generation FVIII Concentrates (No human or animal protein used in the culture medium or manufacturing process; does contain trace amounts of murine monoclonal antibody) | ||
| Advate (Baxter/Immuno, Inc.) (trehalose as a stabilizer) | Immunoaffinity chromatography Ion exchange Solvent detergent (TNBP/polysorbate 80) | Ultra high (> 4000–10,000 IU/mg) |
| Plasma-derived Prothrombin Complex Concentrates/Factor IX complex concentrates (nonactivated; also contain FX & prothrombin but only traces of FVII ) | ||
| Bebulin VH (Baxter/Immuno) | Vapor heat (60°C, 10 hr at 190 mbar pressure plus 1 hr at 80°C, 375 mbar) | Intermediate (< 50 IU/mg) |
| Profilnine SD (Grifols) | Solvent detergent (TNBP/polysorbate 80) | Intermediate (< 50 IU/mg) |
| Proplex-T (Baxter/Immuno) | Dry heat (60°C, 144 hr) | Intermediate (< 50 IU/mg) |
| Plasma-derived Prothrombin Complex Concentrates/Factor IX complex concentrates (activated) | ||
| FEIBA (Baxter/Immuno) | Vapor heating (60°C, 10 hr, 1160 mbar) | Intermediate (< 50 U/mg) |
| Plasma-derived Coagulation Factor IX (human) concentrates | ||
| AlphaNine SD (Grifols) | Dual affinity chromatography Solvent detergent (TNBP/polysorbate 80) Nanofiltration (viral filter) | High (> 200 IU/mg) |
| Mononine (ZLB Behring) | Monoclonal antibody immunoaffinity chromatography Sodium thiocyanate Ultrafiltration | High (> 160 IU/mg) |
| Recombinant F.IX Concentrates | ||
| BeneFIX (Wyeth) (no animal or human-derived protein in cell line; no albumin added to final product) | Affinity chromatography Ultrafiltration | Ultra-high (> 200 IU/mg) |
| Product Name (Manufacturer) . | Viral Inactivation Procedure(s) . | Purity/Specific Activity (IU Factor VIII activity/mg total protein) Before Addition of Stabilizer . |
|---|---|---|
| Human Plasma-derived Factor VIII Concentrates | ||
| Humate-P (ZLB Behring, Inc. ) (Contains functional von Willebrand factor protein) | Pasteurization (heating in solution, 60°C, 10 hr) | Intermediate (1–10 IU/mg) |
| Alphanate SD (Grifols, Inc.) (Contains some functional von Willebrand factor protein) | Solvent detergent (TNBP/Polysorbate 80) Affinity chromatography Dry heat (80°C, 72 hr) | High (50–100 IU/mg) (> 400 IU/mg after correcting for VWF content) |
| Koate-DVI (Bayer, Inc.) (Contains von Willebrand factor protein) | Solvent detergent (TNBP/Polysorbate 80) Dry heat (80°C, 72 hr) | High (50–100 IU/mg) |
| Monoclonal Antibody Purified FVIII Concentrates (Immunoaffinity purified from human plasma, no intact von Willebrand factor protein) | ||
| Monarc-M (Baxter/Immuno, Inc., using recovered plasma from the American Red Cross) | Solvent detergent (TNBP/Octoxynol 9) Immunoaffinity chromatography | Ultra high (> 3000 IU/mg) |
| Hemofil-M (Baxter/Immuno, Inc.) | Solvent detergent (TNBP/Octoxynol 9) Immunoaffinity chromatography | Ultra high (> 3000 IU/mg) |
| Monoclate-P (ZLB Behring, Inc.) | Pasteurization (heated in solution, 60°C, 10 hr) Immunoaffinity chromatography | Ultra high (> 3000 IU/mg) |
| Recombinant (Genetic Engineered)/First Generation FVIII Concentrates | ||
| Recombinate (Baxter/Immuno, Inc.) (human albumin as a stabilizer) | Immunoaffinity, Ion exchange chromatography Bovine serum albumin used in culture medium for Chinese hamster ovary cells | Ultra high (> 4000 IU/mg) |
| Recombinant/Second Generation FVIII Concentrates (human albumin-free final formulations) | ||
| Kogenate FS (Bayer, Inc.) Helixate FS (Bayer for ZLB Behring, Inc.) (sucrose as a stabilizer) | Immunoaffinity chromatography Ion exchange Solvent detergent (TNBP/polysorbate 80) Ultrafiltration | Ultra high (> 4000 IU/mg) |
| Refacto (Wyeth, Inc.) B-domain deleted (sucrose as a stabilizer) | Ion exchange Solvent detergent (TNBP/Triton X-100) Nanofiltration | Ultra high (> 11,200–15,500 IU/mg), measured via chromogenic assay technique |
| Recombinant/Third Generation FVIII Concentrates (No human or animal protein used in the culture medium or manufacturing process; does contain trace amounts of murine monoclonal antibody) | ||
| Advate (Baxter/Immuno, Inc.) (trehalose as a stabilizer) | Immunoaffinity chromatography Ion exchange Solvent detergent (TNBP/polysorbate 80) | Ultra high (> 4000–10,000 IU/mg) |
| Plasma-derived Prothrombin Complex Concentrates/Factor IX complex concentrates (nonactivated; also contain FX & prothrombin but only traces of FVII ) | ||
| Bebulin VH (Baxter/Immuno) | Vapor heat (60°C, 10 hr at 190 mbar pressure plus 1 hr at 80°C, 375 mbar) | Intermediate (< 50 IU/mg) |
| Profilnine SD (Grifols) | Solvent detergent (TNBP/polysorbate 80) | Intermediate (< 50 IU/mg) |
| Proplex-T (Baxter/Immuno) | Dry heat (60°C, 144 hr) | Intermediate (< 50 IU/mg) |
| Plasma-derived Prothrombin Complex Concentrates/Factor IX complex concentrates (activated) | ||
| FEIBA (Baxter/Immuno) | Vapor heating (60°C, 10 hr, 1160 mbar) | Intermediate (< 50 U/mg) |
| Plasma-derived Coagulation Factor IX (human) concentrates | ||
| AlphaNine SD (Grifols) | Dual affinity chromatography Solvent detergent (TNBP/polysorbate 80) Nanofiltration (viral filter) | High (> 200 IU/mg) |
| Mononine (ZLB Behring) | Monoclonal antibody immunoaffinity chromatography Sodium thiocyanate Ultrafiltration | High (> 160 IU/mg) |
| Recombinant F.IX Concentrates | ||
| BeneFIX (Wyeth) (no animal or human-derived protein in cell line; no albumin added to final product) | Affinity chromatography Ultrafiltration | Ultra-high (> 200 IU/mg) |
| Factor VIII (and/or Factor IX) Concentrates Useful in Treatment of Alloantibody and Autoantibody Inhibitor Related Bleeding . | ||
|---|---|---|
| Product Name (Manufacturer) . | Viral Inactivation Method . | Dosage . |
| Recombinant factor VIIa (Genetically engineered) | ||
| NovoSeven (Novo Nordisk, Inc.) (Stabilized in mannitol; bovine calf serum used in culture medium) | Affinity chromatography Solvent/detergent (TNPB/polysorbate 80) | 90 μg/Kg intravenous bolus every 2–3 hr until bleeding ceases (larger dosing regimens are experimental but may be useful in refractory bleeding). This product is the treatment of choice for individuals with allo-factor IX antibody inhibitors and anaphylaxis and/or renal disease associated with the use of factor IX containing concentrates |
| FEIBA-VH (Baxter Immuno, Inc.) (human plasma-derived) | Vapor heated (10 hr, 60°C, 190 mbar plus 1 hr, 80° C, 375 mbar) | 50–100 IU/kg not to exceed 200 IU/kg/24 hr (for factor VIII and IX inhibitors) |
| Porcine Plasma-derived Factor VIII Concentrate | ||
| Hyate C (Ibsen Biomeasure, Inc.) | No longer available | > 50 IU/mg (for factor VIII inhibitors only) |
| Factor VIII (and/or Factor IX) Concentrates Useful in Treatment of Alloantibody and Autoantibody Inhibitor Related Bleeding . | ||
|---|---|---|
| Product Name (Manufacturer) . | Viral Inactivation Method . | Dosage . |
| Recombinant factor VIIa (Genetically engineered) | ||
| NovoSeven (Novo Nordisk, Inc.) (Stabilized in mannitol; bovine calf serum used in culture medium) | Affinity chromatography Solvent/detergent (TNPB/polysorbate 80) | 90 μg/Kg intravenous bolus every 2–3 hr until bleeding ceases (larger dosing regimens are experimental but may be useful in refractory bleeding). This product is the treatment of choice for individuals with allo-factor IX antibody inhibitors and anaphylaxis and/or renal disease associated with the use of factor IX containing concentrates |
| FEIBA-VH (Baxter Immuno, Inc.) (human plasma-derived) | Vapor heated (10 hr, 60°C, 190 mbar plus 1 hr, 80° C, 375 mbar) | 50–100 IU/kg not to exceed 200 IU/kg/24 hr (for factor VIII and IX inhibitors) |
| Porcine Plasma-derived Factor VIII Concentrate | ||
| Hyate C (Ibsen Biomeasure, Inc.) | No longer available | > 50 IU/mg (for factor VIII inhibitors only) |