pharmaceutical market. See Chapter 4 for a description of the role one such product—antihemophilic factor (AHF)—in the treatment of hemophiliacs. The blood banks' sale of their plasma to the commercial plasma fractionator may, but usually does not, involve an agreement to provide some of the manufactured derivatives back to the blood bank. For example, plasma from whole blood collected by the ARC is fractionated through a contract with Baxter Healthcare, which then returns all of the derivatives produced to the ARC for sale through their blood provision system.

The amount of plasma obtained from whole blood is not adequate to meet the needs for raw material to produce plasma derivatives. Therefore, much of the plasma that will be made into derivatives is obtained by plasmapheresis. This plasma is called source plasma, which is ''the fluid portion of human blood collected by plasmapheresis and intended as the source material for further manufacturing use" [C.F.R., 1992]. Automated instruments are usually used to obtain 650–750 milliliters of plasma up to twice weekly from healthy adult donors (approximately 225 cc of plasma can be obtained from 450 ml of whole blood but most plasma is obtained directly through plasmapheresis). An individual can donate up to about 100 liters of plasma annually in the United States if the plasma protein levels and other laboratory tests and physical findings remain normal. The plasma is used as raw material for the manufacture of the derivatives shown in Table 2.3. The production of these plasma derivatives is a complex manufacturing process usually involving large batches of plasma (up to 10,000 liters) from as many 1,000–20,000, or more, donors.

The high demand for plasma products and the lengthy and often uncomfortable procedure of plasmapheresis led to the justification and legalization of compensation for plasma in the United States. Up to the early 1980s, plasma collection centers could be located in prisons and other areas where there was a high prevalence of hepatitis and other chronic infections. With the possible emergence of AIDS in the blood supply, plasma fractionators began closing their prison collection sites in December 1982, and in essence all were closed by January 1984.

Organizations and facilities need licenses for plasma collection (if shipped interstate) and the manufacture of AHF concentrate and other products from plasma.

Plasma Collection

Data regarding the plasma fractionation industry are proprietary and thus not readily available. The FDA does not routinely collect data on the nature of plasma donors, the amount of plasma each organization collects, or the number of derivative products produced. According to the American Blood Resources Association (ABRA), the U.S. plasma and plasma fractionation industry employs



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