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Effects of Plasma Collection Systems and Processing Parameters on the Quality of Factor IX Concentrate 1
Author(s) -
Farrugia A.,
Spiers D.,
Young I.,
Oates A.,
Herrington R.,
Damianos F.
Publication year - 1989
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.1989.tb04975.x
Subject(s) - factor ix , chemistry , yield (engineering) , centrifugation , chromatography , plasma , plasmapheresis , filtration (mathematics) , blood product , size exclusion chromatography , materials science , biochemistry , medicine , immunology , surgery , physics , statistics , mathematics , quantum mechanics , antibody , metallurgy , enzyme
. 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°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.