Comparison among plasma-derived clotting factor VIII by using monodimensional gel electrophoresis and mass spectrometry.
BACKGROUND
Deficiency or dysfunction of coagulation factor VIII (FVIII) is the underlying cause of haemophilia A. Haemophilic patients are at present treated with plasma-derived FVIII (pdFVIII) or recombinant FVIII (rFVIII) in order to correct their clotting deficiency. pdFVIII concentrates are exclusively produced from human plasma upon pooling from multiple donors. It is not know whether the presence of excess of other plasma proteins, in addition to von Willebrand factor, could stimulate untoward immune responses in the recipient. Thus, information regarding the presence of contaminants in commercial products is of concern.


METHODS
Two commercially available pdFVIII concentrates were characterized through SDS-PAGE and mass spectrometry Emoclot and Beriate.


RESULTS
The components of two pdFVIII products considered in this study were well identified by mass spectrometry analysis, in both cases we found abundant components coming from blood plasma, and some other contaminants. Only in Beriate we also found truncated form of pdFVIII.


CONCLUSIONS
The two pdFVIII examined showed the presence of vWF, Fibrinogen in excess, and other substances that could be considered as contaminants or impurities.
Timperio
Anna Maria
AM
Dipartimento di Scienze Ambientali, Università della Tuscia, Viterbo, Italy. timperio@unitus.it
Gevi
Federica
F
Grazzini
Giuliano
G
Vaglio
Stefania
S
Zolla
Lello
L
D004340:Drug Contamination; D004591:Electrophoresis, Polyacrylamide Gel / Q000379:methods*; D005169:Factor VIII / Q000592:standards* / Q000627:therapeutic use; D006467:Hemophilia A / Q000188:drug therapy*; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods*; D011506:Proteins / Q000032:analysis
D011506:Proteins; C078147:F8 protein, human; D005169:Factor VIII