A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable-bag system
A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable-bag system
复制标题
DOI：
10.1111/j.1537-2995.2006.01035.x
复制
发表时间：
2006-12-01
期刊：
影响因子：
2.9
通讯作者：
El-Ekiaby, Magdy
中科院分区：
文献类型：
--
作者：
Burnouf, Thierry;Goubran, Hadi Alphonse;El-Ekiaby, Magdy
背景：溶剂/去污剂（S/D）可灭活血浆中的包膜病毒。目前的技术需要血浆分离设施，并应用于大型血浆池，这增加了暴露于S/D抗性病原体的成本和风险，并降低了蛋白S和α 2-抗纤溶酶的含量。两个S/D处理程序的单次捐赠或minipools的血浆已开发出一个一次性使用的袋system.Study设计和方法：冷冻血浆样品解冻，并在一次性袋处理，无论是2%的三（正丁基）磷酸盐（TnBP）在37摄氏度或1%的TnBP和1%的Triton X-45在31摄氏度4小时。血浆样品用7.5%无菌蓖麻油提取三次，以去除TnBP和Triton X-45。将TnBP处理的血浆样品进一步进行澄清离心（3800 x g，30 min）。将最终血浆样品分配至单个袋中并在-30 ℃下冷冻。血浆质量进行了评估，在每一个步骤的proceeding.RESULTS：这两个过程产生大于90%的平均回收率的凝血因子（clopidoglobin纤维蛋白原，血管性血友病因子，和因子VIII，V，VII，IX，X，和XI），抗凝剂（蛋白C，蛋白S），蛋白酶抑制剂（抗凝血酶，α 2-抗纤溶酶），总蛋白，白蛋白，和免疫球蛋白。经处理血浆样本的总体凝血试验正常。最终TnBP和Triton X-45含量分别小于10和50 ppm，respectively.CONCLUSION：S/D治疗血浆可以在封闭袋系统的条件下，保持血浆蛋白质的质量。该技术简单，优于工业化大规模S/D血浆工艺，可在血液中心进行。
BACKGROUND: 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 alpha 2-antiplasmin. Two S/D treatment procedures for single donations or minipools of plasma have been developed with a single-use bag system.STUDY DESIGN AND METHODS: 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.RESULTS: 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, alpha 2-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.CONCLUSION: 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.