A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable‐bag system
- 29 November 2006
- journal article
- Published by Wiley in Transfusion
- Vol. 46 (12), 2100-2108
- https://doi.org/10.1111/j.1537-2995.2006.01035.x
Abstract
Solvent/detergent (S/D) inactivates enveloped viruses in plasma. The current technology requires a plasma fractionation facility and is applied to large plasma pools, which increases the cost and risks of exposure to S/D-resistant pathogens and lowers the content of protein S and alpha2-antiplasmin. Two S/D treatment procedures for single donations or minipools of plasma have been developed with a single-use bag system.Frozen plasma samples were thawed and treated in disposable bags with either 2 percent tri(n-butyl)phosphate (TnBP) at 37 degrees C or 1 percent TnBP and 1 percent Triton X-45 at 31 degrees C for 4 hours. Plasma samples were extracted three times with 7.5 percent sterile castor oil to remove TnBP and Triton X-45. The TnBP-treated plasma samples were further subjected to a clarifying centrifugation (3800 x g, 30 min). Final plasma samples were dispensed into individual bags and frozen at -30 degrees C. Plasma quality was assessed at each step of the procedures.Both processes yielded greater than 90 percent mean recovery of coagulation factors (clottable fibrinogen, von Willebrand factor, and factors VIII, V, VII, IX, X, and XI), anticoagulants (protein C, protein S), protease inhibitors (antithrombin, alpha2-antiplasmin), total protein, albumin, and immunoglobulins. Global coagulation tests of the treated plasma samples were normal. Final TnBP and Triton X-45 content was less than 10 and 50 ppm, respectively.S/D treatment of plasma can be performed in a closed-bag system under conditions that maintain plasma protein quality. The technology is simple, presents advantages over the industrial large-scale S/D plasma process, and could be performed in blood centers.Keywords
This publication has 38 references indexed in Scilit:
- Pathogen inactivation technology: cleansing the blood supplyJournal of Internal Medicine, 2005
- Coagulation factor content of solvent/detergent plasma compared with fresh frozen plasmaBlood Coagulation & Fibrinolysis, 2003
- Nanofiltration of single plasma donations: feasibility studyVox Sanguinis, 2003
- von Willebrand factor‐cleaving protease activity in congenital thrombotic thrombocytopenic purpuraBritish Journal of Haematology, 2000
- Evaluation of Solvent/Detergent‐Treated Plasma in Patients with a Prolonged Prothrombin TimeVox Sanguinis, 2000
- Cryoprecipitate prepared from plasma virally inactivated by the solvent detergent methodBritish Journal of Haematology, 1997
- Plasma exchange with solvent/detergent‐treated plasma of resistant thrombotic thrombocytopenic purpuraBritish Journal of Haematology, 1996
- Evaluation of solvent/detergent treated plasma in the management of patients with hereditary and acquired coagulation disordersBlood Coagulation & Fibrinolysis, 1993
- Virus Inactivation of Fresh Frozen Plasma by a Solvent Detergent Procedure: Biological ResultsVox Sanguinis, 1992
- Manufacture and in vitro Characterization of a Solvent/Detergent‐Treated Human PlasmaVox Sanguinis, 1992