Effects of plasma collection systems and processing parameters on the quality of factor IX concentrate.
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.
Farrugia
A
A
Blood Products Division, Commonwealth Serum Laboratories, Parkville, Victoria, Australia.
Spiers
D
D
Young
I
I
Oates
A
A
Herrington
R
R
Damianos
F
F
D005591:Chemical Fractionation / Q000379:methods; D005069:Evaluation Studies as Topic; D005164:Factor IX / Q000302:isolation & purification* / Q000592:standards; D006358:Hot Temperature; D006801:Humans; D010949:Plasma / Q000032:analysis*; D010956:Plasmapheresis / Q000379:methods*; D013927:Thrombosis / Q000209:etiology
D005164:Factor IX