Plasma for fractionation: safety and quality issues

Abstract

Plasma may be procured for use as a therapeutic product or as a raw material for manufacture 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 plasmapheresis; 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.