A solvent I detergent treated, pasteurised and highly purified factor VIII concentrate.

ABSTRACT

In an assessment of the risks of virus transmission by clotting concentrates it is clear that the currently practised procedures for virus inactivation are not equally effective against all types of viruses; neither a pasteurisation nor the solvent detergent (SID) process alone are adequate enough to inactivate viruses that are strongly resistant to heat and organic solvents. In this context, human parvovirus B19 and hepatitis A virus (HAV) are of particular concern. In order to improve this situation which still poses a risk to the haemophiliac patients, a more effective pasteurisation process has been developed that could be easily applied to an already well established factor VIII (FVIII) process in addition to the SID-treatment. Experiments using temperatures above 60 degrees C were performed prompted by two recent publications, which demonstrate that HAV becomes instable at temperatures exceeding 62 degrees C. It is the purpose of this paper to present the following progress achievement of a pasteurisation procedure for FVIII at 63 degrees C for 10 h with no discernible change in the structure of the factor VIII/von Willebrand factor (FVIII/VWF) complex owing to a newly developed composition of stabilizers; application of this pasteurisation procedure to a purified FVIII fraction that has already been submitted to a SID-treatment Doing so, two independent virus inactivation steps are performed as previously recommended by the International Association of Biological Standardization (IABS). Introduction of a second purification step on an anion exchange resin, achieving an additional virus reduction over the presently manufactured FVIII preparation.(ABSTRACT TRUNCATED AT 250 WORDS)