Characteristics of 3 Clotting Factor Concentrates
| Brand* . | Clotting Factor . | Production Steps After Cryoprecipitation of Plasma Source (viral inactivation) . | TTV DNA Positive/ Total Investigated Lots (%) . |
|---|---|---|---|
| A | Factor VIII | (1) Ion-exchange chromatography | 28/28 (100%) |
| (2) Nano-filtration | |||
| (3) Dry heat 65°C, 96 h | |||
| B | Factor VIII | (1) Solvent/detergent† treatment | 0/24 (0%) |
| (2) Immunoaffinity chromatography | |||
| (3) Ion-exchange chromatography | |||
| C | Factor IX | (1) Immunoaffinity chromatography | 0/25 (0%) |
| (2) Ion-exchange chromatography | |||
| (3) Nano-filtration | |||
| (4) Dry heat 65°C, 96 h |
| Brand* . | Clotting Factor . | Production Steps After Cryoprecipitation of Plasma Source (viral inactivation) . | TTV DNA Positive/ Total Investigated Lots (%) . |
|---|---|---|---|
| A | Factor VIII | (1) Ion-exchange chromatography | 28/28 (100%) |
| (2) Nano-filtration | |||
| (3) Dry heat 65°C, 96 h | |||
| B | Factor VIII | (1) Solvent/detergent† treatment | 0/24 (0%) |
| (2) Immunoaffinity chromatography | |||
| (3) Ion-exchange chromatography | |||
| C | Factor IX | (1) Immunoaffinity chromatography | 0/25 (0%) |
| (2) Ion-exchange chromatography | |||
| (3) Nano-filtration | |||
| (4) Dry heat 65°C, 96 h |
All products are made in Japan from plasma source taken from domestic, screened volunteers. Individual donor plasma is screened using serologic tests for syphillis, HIV1, HIV2, HTLV-1, HBsAg, HBcAb, HCVAb, and ALT. Abnormal plasma is excluded. Brand A and C are made by the same company.
Tri-(n-butyl)-phosphate (TNBP)/Triton X-100.