over 12,000 people nationwide (Scott 1990). U.S. plasma collection facilities perform approximately 13 million plasmapheresis donor collection procedures annually. Thus, if an average of 700 ml of plasma is obtained from each donation, it could be estimated that approximately 9 million liters of plasma would be collected annually in the United States by plasma centers. Individuals who donate plasma to support the plasma fractionation industry receive between $15 and $20 per donation. According to the ABRA, donors receive compensation of more than $244 million from plasma collection facilities annually (ABRA 1994). This is in contrast to whole blood donors, who donate voluntarily and do not receive compensation. Much of the plasma obtained from whole blood collected by blood banks is also used for production. Blakestone has estimated that in 1990 approximately 12 million liters of plasma were consumed in the manufacture of plasma derivatives (Blakestone 1994).

It is estimated that plasma fractionation worldwide sales exceed $4 billion annually, with U.S. firms providing more than 60 percent of the plasma products or $2.4 billion in domestic and export sales annually (ABRA 1994). Of the $2.4 billion in domestic and export sales, $645 million is the estimated export revenue from sales of U.S. plasma products in Europe.

Plasma Processing

The collected plasma is sent from the collection site to a fractionation laboratory, which in the United States, is either owned by a pharmaceutical company or by an outside company that sells the fractionated plasma to the pharmaceutical company. Fractionation involves further separation of the plasma into proteins such as albumin, immunoglobulin, and AHF concentrates. A pool size of at least 1,000 donors is required by the FDA for the production of immunoglobulin products used in the treatment of infectious disease, because increasing the pool size concentrates the therapeutic antibody portion of plasma. Pooling was more efficient for production in the manufacturing process of AHF concentrates because clotting factor proteins are found in extremely small quantities in plasma. Pooling plasma also has the negative effect of increasing chances for contracting infectious disease (see Chapter 4).



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