Factor viii concentrates prepared from heparinized plasma by...

A - Human Necessities – 61 – K

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A61K 35/14 (2006.01) C07K 14/755 (2006.01) A61K 38/00 (2006.01)

Patent

CA 1178887

ABSTRACT OF THE DISCLOSURE A method for recovering Antihemophilic Factor VIII from whole blood or blood plasma or blood plasma fractions freshly collected directly into an anticoagulant selected from the group of heparin, sodium heparin, or mixtures thereof, the heparin being used in the range of 6 - 8 units/ml of plasma or 3.5 - 4 units/ml of blood; and either first separating the red cells from the plasma and/or freezing the heparinized plasma, resolubilizing the plasma, isolating a cryoprecipitate from the plasma, resolubilizing the cryoprecipitate, adding a saline heparin solution to the resolubilized cryoprecipitate, incubating the resolubilized cryoprecipitate at a temperature of from a out 0°C to about 4°C for a time of at least 2 hours, whereby Factor VIII present in the cryoprecipitate is insolubilized using heparin precipitable cold insoluble globulin and the resulting Factor VIII rich precipitate also includes cold insoluble globulin, separating the Factor VIII rich precipitate, and isolating Factor VIII therefrom. This new process permits recovery of a high purity Factor VIII preparation which can easily be made in the blood bank or alternatively, the cold precipitation step can be carries out in a fractionation plant.

387063

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