Results of a quality-control study of lyophilized pooled plasmas which have been 'virally inactivated' using a...

The 'virus-free' lyophilized pooled plasmas supplied to our institute by the German Red Cross in Hagen did not meet the quality norms found in standard products. Indeed, with respect to all the major parameters, they deviated greatly from standard coagulative fresh frozen plasmas. In order to achieve a suitable substitution effect and approximate the properties of fresh plasma, it would be necessary to administer two to three times the amount of 'virus-free' plasma. At the same time it should be noted that by contrast to coagulative fresh plasma, the new product neither compensates for factors which activate or inhibit coagulation, nor for fibrinolytic factors. On the contrary, the ratio between these factors deviates dangerously from their physiological equilibrium. Grave therapeutic consequences can be expected therefrom. In addition, most of the tested batches already contain heparin in quantities within the therapeutic range in spite of the fact that the manufacturer neglects to mention this detail. Finally, the method of preparation pushes the pH values far into the alkaline range. This fact alone could have fatal consequences if this product was administered to severely ill patients. In general, we can only express our surprise that the Bundesgesundheitsamt (German Health Board), as the official body responsible for approving this product, has agreed to its distribution on the basis of notification that changes would be made to an existing approved product. The following facts, in our opinion, should have determined the renewal of the licence for sale: As opposed to the approved product--a plasma derived from individual donors--the 'virus-free' plasma is a pooled plasma. As opposed to the approved product--a deep-frozen plasma derived from individual donors--the 'virus-free' plasma is a pooled lyophilized plasma. As opposed to the approved product which is not subjected to any chemical processing, the 'virus-free' product is treated with tri(n)butylphosphate and an unspecified detergent. These virucidal properties are assumed on the basis of consequential logic rather than proven by hard experimentally determined fact. Data confirming the efficiency of the process based on legitimate animal experiments has not be presented. In spite of all the efforts to improve safety in transfusion medicine we believe that if certain nonprofit-making blood banks are to retain their credibility, they should be subjected to the same stringent laws and regulations that are applied to the rest of the German pharmaceutical industry.(ABSTRACT TRUNCATED AT 400 WORDS)