U Kalina1, H Bickhard, S Schulte. 1. Research and Development, CSL Behring, Marburg, Germany. uwe.kalina@cslbehring.com
Abstract
AIMS: A number of prothrombin complex concentrates (PCCs) are commercially available but they differ in terms of composition. We performed a series of studies to compare the biochemical properties of seven PCCs. METHODS: The following products were investigated: Beriplex P/N, Octaplex, S-TIM 4, PPSB Solvent Detergent, Uman Complex DI, Kaskadil and Cofact. Assays were performed to investigate levels of coagulation factors and their inhibitors, activated coagulation factors and heparin. The thrombin inhibitory capacity of each PCC was determined. Protein content was assessed using the Lowry method and sodium dodecyl sulphate-polyacrylamide gel electrophoresis. RESULTS: The data indicated little difference between most of the products in their levels of factors II, VII, IX and X, with the exception of Uman Complex which had no detectable factor VII. In all cases, the measured levels of coagulation factors were broadly similar to those labelled. Beriplex P/N showed the greatest capacity for thrombin inhibition, a reflection of the observed high levels of the coagulation inhibitors protein C, protein S, protein Z, and small amounts of antithrombin III and heparin in this product. All of the PCCs tested were negative for activated coagulation factors. Purity (i.e. therapeutic protein as a percentage of total protein) was highest in Beriplex P/N, and the second purest product was Uman Complex. CONCLUSION: This in vitro study showed considerable differences between PCCs in terms of coagulation inhibitory capacity and purity.
AIMS: A number of prothrombin complex concentrates (PCCs) are commercially available but they differ in terms of composition. We performed a series of studies to compare the biochemical properties of seven PCCs. METHODS: The following products were investigated: Beriplex P/N, Octaplex, S-TIM 4, PPSB Solvent Detergent, Uman Complex DI, Kaskadil and Cofact. Assays were performed to investigate levels of coagulation factors and their inhibitors, activated coagulation factors and heparin. The thrombin inhibitory capacity of each PCC was determined. Protein content was assessed using the Lowry method and sodium dodecyl sulphate-polyacrylamide gel electrophoresis. RESULTS: The data indicated little difference between most of the products in their levels of factors II, VII, IX and X, with the exception of Uman Complex which had no detectable factor VII. In all cases, the measured levels of coagulation factors were broadly similar to those labelled. Beriplex P/N showed the greatest capacity for thrombin inhibition, a reflection of the observed high levels of the coagulation inhibitors protein C, protein S, protein Z, and small amounts of antithrombin III and heparin in this product. All of the PCCs tested were negative for activated coagulation factors. Purity (i.e. therapeutic protein as a percentage of total protein) was highest in Beriplex P/N, and the second purest product was Uman Complex. CONCLUSION: This in vitro study showed considerable differences between PCCs in terms of coagulation inhibitory capacity and purity.
Authors: Santiago R Leal-Noval; Manuel Muñoz; Marisol Asuero; Enric Contreras; José A García-Erce; Juan V Llau; Victoria Moral; José A Páramo; Manuel Quintana Journal: Blood Transfus Date: 2013-06-17 Impact factor: 3.443