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2.5 The plasma collection system

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A method was developed at the beginning of World War II to process large volumes of plasma so that some of the proteins could be isolated, concentrated, and used for medical purposes [32]. This plasma “fractionation” process is the basis for a large industry that provides many medically valuable products generally referred to as plasma “derivatives” [33–35]. The plasma for production of these derivatives is obtained by plasmapheresis. Members of the Plasma Protein Therapeutics Association (PPTA) carry out approximately 44 million plasmapheresis procedures annually and collected about 44 million liters of plasma [35]. There are many US Food and Drug Administration (FDA)–licensable plasma derivatives (see Chapter 5). The production of these plasma derivatives is a complex manufacturing process that takes 7–9 months and usually involves batches up to 10,000 L of plasma or plasma from as many as 50,000 donors (see Plasma Protein Therapeutics Association section later in this chapter).

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