Flesland O, Seghatchian J, Solheim B G
Blood Bank, Baerum Hospital, N-1306 Barum, Norway.
Transfus Apher Sci. 2003 Feb;28(1):93-100. doi: 10.1016/S1473-0502(02)00104-0.
The establishment of the Norwegian Fractionation Project (Project) was of major importance in preserving national self-sufficiency when plasma, cryoprecipitate and small batch factor IX-concentrates were replaced by virus inactivated products in the last part of the 1980s. Fractionation was performed abroad by contract with Octapharma after tenders on the European market. All Norwegian blood banks (>50) participated in the Project. Total yearly production was 50-60 tons of mainly recovered plasma. From 1993 solvent detergent (SD) treated plasma has replaced other plasma for transfusion. The blood banks paid for the fractionation and/or viral inactivation process, while the plasma remained the property of the blood banks and the final products were returned to the blood banks. The Project sold surplus products to other Norwegian blood banks and the majority of the coagulation factor concentrates to The Institute of Haemophilia and Rikshospitalet University Hospital. Both plasma and blood bank quality was improved by the Project. Clinical experience with the products has been satisfactory and self-sufficiency has been achieved for all major plasma proteins and SD plasma, but a surplus exceeding 3 years consumption of albumin has accumulated due to decreasing clinical use.The Project has secured high yields of the fractionated products and the net income from the produced products is NOK 1115 (140 Euros or US dollars) per litre plasma. An increasing surplus of albumin and the possibility of significant sales abroad of currently not fractionated IVIgG, could lead to a reorganisation of the Project from that of a co-ordinator to a national plasma handling unit. This unit could buy the plasma from the blood banks and have the plasma fractionated by contract after tender, before selling the products back for cost recovery. The small blood banks could produce plasma for products for the Norwegian market, while surplus products from the larger blood banks which are certified for delivery of plasma for fractionation of products to be consumed in the European Community, could be sold on the international market.
20世纪80年代后期，当血浆、冷沉淀和小批量凝血因子IX浓缩物被病毒灭活产品取代时，挪威血浆成分分离项目（该项目）的建立对于维持国家自给自足具有重要意义。通过在欧洲市场招标后，与奥克泰士（Octapharma）签订合同，在国外进行成分分离。所有挪威血库（超过50家）都参与了该项目。每年总产量为50 - 60吨，主要是回收血浆。自1993年起，经溶剂去污剂（SD）处理的血浆已取代其他用于输血的血浆。血库支付成分分离和/或病毒灭活过程的费用，而血浆仍为血库财产，最终产品返还给血库。该项目将剩余产品出售给其他挪威血库，并将大部分凝血因子浓缩物出售给血友病研究所和里克斯医院大学医院。该项目提高了血浆和血库的质量。产品的临床经验令人满意，所有主要血浆蛋白和SD血浆均实现了自给自足，但由于临床使用减少，白蛋白积累了超过3年消费量的过剩库存。该项目确保了成分分离产品的高产量，生产产品的净收入为每升血浆1115挪威克朗（140欧元或美元）。白蛋白过剩情况日益增加，以及目前未进行成分分离的静脉注射免疫球蛋白（IVIgG）有大量出口的可能性，可能导致该项目从协调者角色转变为国家血浆处理单位。这个单位可以从血库购买血浆，在招标后通过合同进行血浆成分分离，然后再将产品卖回以收回成本。小型血库可以生产用于挪威市场产品的血浆，而经认证可提供用于在欧洲共同体消费的产品成分分离血浆的大型血库的剩余产品，则可以在国际市场上销售。
