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• W2022676922 abstract "The small-scale production of a severely heated factor VIII concentrate is described. As starting material for the production 48 units of fresh frozen plasma from whole-blood donations or 24 units of plasma from apheresis are used. During a glycine and sodium chloride fractionation, contaminating proteins are removed from a pooled extract of single-donor cryoprecipitates. The resulting factor VIII-rich precipitate is redissolved in freeze-drying buffer and this solution is desalted by diafiltration. After filtration, this solution is dispensed into 10 vials and frozen. The product is freeze dried, and heat treated at 80°C for 72 h. The mean yield of the heat-treated product improved from 160 IU factor VIII per liter plasma at the start of the production to 215 IU per liter plasma after a modification of the purification process. The validation of the virus inactivation during freeze-drying and 80°C heat treatment for 72 h showed a reduction of ≥7.6 log PFU/ml for Sindbis and a reduction of ≥6.4 log TCID50/ml for HIV-1. The factor VIII concentrate was clinically tested in 6 patients. It possessed a normal half-life, showed a high recovery and no side effects. A Dutch license was granted in June 1991 and since then this product has been routinely manufactured in three Dutch blood banks." @default.
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• W2022676922 date "1994-02-01" @default.
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• W2022676922 title "Development and Small-Scale Production of a Severely Heated Factor VIII Concentrate" @default.
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• W2022676922 doi "https://doi.org/10.1111/j.1423-0410.1994.tb00288.x" @default.
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