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  • Title: Effects of plasma collection systems and processing parameters on the quality of factor IX concentrate.
    Author: Farrugia A, Spiers D, Young I, Oates A, Herrington R, Damianos F.
    Journal: Vox Sang; 1989; 57(1):4-9. PubMed ID: 2800464.
    Abstract:
    Using pilot-scale production of our present factor IX (II and X) concentrate, we have studied the effects of starting plasma source and processing parameter on two in-vitro indicators of product quality - yield and thrombogenic potential. Plasma source did not affect factor IX yield but had a marked effect on thrombogenic potential. Factor IX concentrates produced from plasma derived through centrifugation-based technology showed significantly higher thrombogenic potential than products derived from plasma derived through a filtration-based system. Removal of Cohn fraction I prior to ion-exchange chromatography resulted in a drop in factor IX yield and thrombogenic potential, as did heat treatment to 80 degrees C for 72 h. We conclude that a membrane-filtration-based plasmapheresis system may be the preferred method of plasma procurement for factor IX concentrate production.
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