Preparing lyophilized plasma with the preserved activity of coagulation factors

The use of a freeze-dried plasma has a number of advantages over fresh frozen plasma (FFP) as for the provision of transfusion care in the field conditions, as well for the carrying out diagnostic studies of the hemostatic system. The execution of diagnostic tests requires for the availability of Biological Standards, plasma calibrator and control material with high stability of target indices in the storage of lyophilized reagents. Plasma lyophilization process causes significant changes in coagulation indices and is accompanied by an increase in plasma pH. The aim of the study was to obtain a freeze-dried human plasma without the pronounced changes in the activity of clotting factors under lyophilization and storage. The acidification of pooled FFP from at least 20 donors before lyophilization to pH values of 7.0–7.1 by HEPES buffer solution at a final concentration of 50 mM was shown to increase the stability of the hemostatic system factors and retain physiological plasma pH after lyophilisation. In conditions of an accelerated storage just so lyophilized plasmas are characterized by the greater stability of all determined coagulation indices. Thus, the proposed approach makes it possible to obtain storage-stable, lyophilized forms of diagnostic reagents and control materials.

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