REVIEW ARTICLE Plasma for fractionation: safety and quality issues A. FARRUGIA Blood and Tissues unit, Office of Devices, Blood and Tissues, Australian Therapeutic Goods Administration, Woden ACT, Australia Summary. Plasma may be procured for use as a therapeutic product or as a raw material for manu- facture of other products, and may be collected as a by-product of whole blood, or as a plasma donation from aphaeresis. When collected for fractionation, the quality and safety of the plasma are intimately linked to the quality and safety of the manufactured plasma derivatives. High quality plasma can be obtained either from whole blood or from plasmaph- eresis; quality can, however, be adversely affected by poor storage conditions after collection. Quality standards for plasma for fractionation are necessarily different than for plasma for transfusion and, with modern fractionation methods, certain quality aspects become less relevant. Similarly, the relevance of certain recent technological advances, such as nucleic acid testing (NAT), for maximizing the safety of plasma for fractionation are questionable, although their introduction through the linkage of recovered plasma to whole blood collection can improve the safety of fresh blood components. Viruses that are not screened for at blood banks may also be excluded from the plasma pool they are more clinically relevant when multiple products made from a pool may infect a large number of recipients, in contrast to components given to one or a small number of patients. Keywords: plasma, products, safety Introduction Worldwide, the development of a plasma deriva- tives industry has followed two basic paths. In systems where blood transfusion services have evolved as a result of direct government interven- tion in health care, the collection of whole blood to sufficient levels is needed to adequately cover fresh product 1 clinical needs. Coupled with the imple- mentation of component therapy rather than whole blood use, this inevitably results in the generation of plasma recovered from whole blood in amounts, which are in excess to those used for direct transfusion. In this environment, plasma fraction- ation has developed as an adjunct of blood trans- fusion services, and has been based upon the fractionation of plasma recovered from the whole blood donations of, predominantly, voluntary blood donors. In systems where the plasma derivatives sector has been encouraged to develop as part of the mainstream pharmaceutical industry, the predomin- ant procurement mode for the raw material has been source plasma generated through aphaeresis, resulting in considerably higher quantities of plasma being available for fractionation compared with the recovered route. The mainstay of this sector has been the commercial fractionation industry in the USA, and its attendant plasma collection arm based on paid donors. The emerging fractionation indus- try in China is also based on paid source plasma collection, and the potential for growth in this sector, parts of which are attempting to move to a volunteer donor base, is obvious. However, at this stage, the world’s supply of plasma derivatives is still heavily dependent on the commercial collection sector in the USA. 1 In this work, fresh products are those labile components of mainstream blood banking such has red cells, platelets and plasma for transfusion. 2 Model viruses are necessary for HCV as the virus itself cannot be cultured and used for inactivation studies. Correspondence: Albert Farrugia, Blood and Tissues Unit, Office of Devices, Blood and Tissues, Australian Therapeutic Goods Administration, PO Box 100, Woden ACT, Australia 2606. E-mail: albert.farrugia@health.gov.au Accepted after revision 18 March 2004 Haemophilia (2004), 10, 334–340 DOI: 10.1111/j.1365-2516.2004.00911.x 334 Ó 2004 Blackwell Publishing Ltd