Supply challenges: The collector's view

Human blood plasma sets the global plasma fractionation industry apart. Plasma has unique characteristics as a human-derived biological material that go well beyond the physical and economic properties of any other industrial raw material – although these properties are also critical. This chapter is intended to briefly provide an overview of the global supply of plasma as a source of life-saving therapies and the issues that the plasma collection industry faces today. The global supply of plasma that is used for fractionation into therapies is approximately 32 million liters today. Most plasma used is called “normal” – meant in a statistical sense in that the plasma is drawn from the general population. In addition, smaller (but critically) important volumes of “hyper-immune” plasma is produced which typically has elevated levels of a particular antibody. These hyper-immune plasmas can be produced either by donor screening and selection or by immunizing the donors to elicit a particular immuno-response. In addition, plasma is used directly for therapy in many countries and smaller volumes are used for various diagnostic purposes. The other major distinction is between “recovered” and “source” plasma. The former is produced as a by-product of whole blood collection. The cellular components are separated from the whole blood and (usually) used for transfusion or another therapy, leaving the “recovered” plasma. Source plasma is similarly separated from whole blood, but the separation is done almost simultaneously with blood donation and the cellular components are returned to the donor almost immediately. This process is called plasma-pheresis. In most countries, the process is automated (“auto-pheresis”) through filtration or centrifugation technologies. Putting the pieces together, almost all the plasma used for fractionation in the world is either NRP (Normal Recovered Plasma) or NSP (Normal Source Plasma) – and this nomenclature will be used for the rest of this chapter. For various historical, cultural and regulatory reasons, recovered plasma is most commonly collected by not-for-profit organizations such as agencies of government, the National Societies of the Red Cross and Red Crescent or community blood banks. The focus of these organisations is often primarily upon the cellular components of whole blood. It is also generally true that donors of whole blood consider themselves