Burnouf T
Human Plasma Product Services (HPPS), 18 rue Saint-Jacques, 59000 Lille, France.
Transfus Clin Biol. 2007 May;14(1):41-50. doi: 10.1016/j.tracli.2007.04.002. Epub 2007 May 11.
From 22 to 25 million liters of plasma are fractionated yearly in about 70 fractionation plants, either private or government-owned, mainly located in industrialized countries, and with a capacity ranging from 50000 to three million liters. In an increasingly global environment, the plasma industry has recently gone through a major consolidation phase that has seen mergers and acquisitions, and has led to the closure of a number of small plants in Europe. Currently, some fifteen countries are involved into contract plasma fractionation programs to ensure a supply of plasma-derived medicinal products. The majority of the plasma for fractionation is obtained by automated plasmapheresis, the remaining (recovered plasma) being prepared from whole blood as a by-product of red cell production. Plasma for fractionation should be produced, and controlled following well established procedures to meet the strict quality requirements set by regulatory authorities and fractionators. The plasma fractionation technology still relies heavily on the cold ethanol fractionation process, but has been improved by the introduction of modern chromatographic purification methods, and efficient viral inactivation and removal treatments, ensuring quality and safety to a large portfolio of fractionated plasma products. The safety of these products with regards to the risk of transmission of variant Creutzfeldt-Jakob disease seems to be provided, based on current scientific data, by extensive removal of the infectious agent during certain fractionation steps. The leading plasma product is now the intravenous immunoglobulin G, which has replaced factor VIII and albumin in this role. The supply of plasma products (most specifically coagulation products and immunoglobulin) at an affordable price and in sufficient quantity remains an issue; the problem is particularly acute in developing countries, as the switch to recombinant factor VIII in rich countries has not solved the supply issue and has even led to an increase of the mean price of plasma-derived factor VIII to the developing world. In the last few years, the plasma fractionation industry has improved greatly, and should remain essential in the years to come for the procurement of many essential medicines.
每年约有70家血浆分离厂（包括私营和国有，主要位于工业化国家）对2200万至2500万升血浆进行分离，这些工厂的产能从5万升至300万升不等。在日益全球化的环境中，血浆行业最近经历了重大整合阶段，出现了并购情况，并导致欧洲一些小型工厂关闭。目前，约有15个国家参与了合同血浆分离计划，以确保血浆衍生药品的供应。用于分离的大部分血浆是通过自动化单采血浆术获得的，其余的（回收血浆）则是作为红细胞生产的副产品从全血中制备而来。用于分离的血浆应按照既定程序生产和控制，以满足监管机构和分离厂设定的严格质量要求。血浆分离技术仍严重依赖冷乙醇分离法，但通过引入现代色谱纯化方法以及高效的病毒灭活和去除处理得到了改进，确保了大量分离血浆产品的质量和安全性。根据目前的科学数据，通过在某些分离步骤中广泛去除感染因子，这些产品在传播变异型克雅氏病风险方面的安全性似乎得到了保障。目前领先的血浆产品是静脉注射免疫球蛋白G，它已取代因子VIII和白蛋白成为主要产品。以可承受的价格和充足的数量供应血浆产品（最特别是凝血产品和免疫球蛋白）仍然是一个问题；在发展中国家，这个问题尤为严重，因为富裕国家转向重组因子VIII并未解决供应问题，甚至导致向发展中世界供应的血浆衍生因子VIII平均价格上涨。在过去几年中，血浆分离行业有了很大改进，并且在未来几年对于许多基本药物的采购仍将至关重要。
